Abbrev
C42610
eTMF
String
Preferred Abbreviation of term name
Abbreviation
Core
Abbreviation
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42610
Annotation Property
Abbreviation
X99004
eTMF
String
Annotation Properties are used to provide annotations for a content model entity or term. For more, refer to general description at: http://www.w3.org/TR/owl2-syntax/#Annotation_Properties
Annotation Property
Core
Annotation Property
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Annotation_Property
Annotation Property
Annotation Property
X99001
eTMF
String
A single collection of related digital content items within a digital repository, for example a collection of clinical trial documents for a single clinical trial Study. File based or database. Child entities = Categories, Organization, Person, Data Property, Annotation Property
Archive
Core
Archive
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Archive
Annotation Property
Archive
C25372
eTMF
String
A hierarchical classification of content items within an archive, with child SubCategories and Content Types. assignments, Annotation Property values
Category
Core
Category
Required If Applicable
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25372
Annotation Property
Category
Cat Code
C93524
eTMF
String
A coded value specifying a Category or Content Type classification using the CareLex Classification numbering scheme. Required for every Category and Content Type. For example, 100.11 *
Category Code
Core
Category Code
Required If Applicable
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C93524
Annotation Property
Category Code
C42614
eTMF
String
The word or phrase used by preference to refer to an entity or a term, including Category, Content Type, Data Property, Annotation Property, Organization, Person
Category Code
Core
Category Code
Required If Applicable
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42614
Annotation Property
Category Name
X99005
eTMF
String
Specifies whether a category used in a content model is a published (Core) category or an organization-specific Category for internal use
Category Type
Core
Category Type
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Category_Type
Annotation Property
Core; Organization Specific
Category Type
C25162
eTMF
String
Code for the Category, Content Type, Data Property term or Annotation Property Term. NCI Thesaurus codes begin with ‘C’; CareLex term codes begin with an X; Codes which are pending review by CareLex begin with ‘Y’, and both organization-specific and general metadata codes begin with a ‘Z’. All codes are 1 alpha char (a-z) and 5 numeric characters 0-9.
Code
Core
Code
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25162
Annotation Property
Code
C99095
eTMF
String
A single digital file. Includes digital documents, images, multimedia or other digital content. Has one and only one Content Type parent. Child entities = Data Property assignments, Data Property values
Content Item
Core
Content Item
Required If Applicable
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C99095
Annotation Property
Content Item
X99008
eTMF
String
Specifies the content model that the term belongs to. A content content model defines how content can be classified for a specific business domain. It is similar to an electronic filing system folder structure, where content or documents are classified and assigned properties. A content model is structured as an ontology comprised of a hierarchical taxonomy of content categories, content or document types and data properties or metadata. The relationships between content types and data properties are described in a machine readable computer language known as RDF/XML.
Content Model
Core
Content Model
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Content_Model
Annotation Property
Content Model
X99002
eTMF
String
A content type is a reusable collection of metadata, business processes, behavior, and other settings for a category of items or documents in electronic content material.
Content Type
Core
Content Type
Required If Applicable
Document Type
CareLex
http://www.CareLex.org/2012/carelex.owl#Content_Type
Annotation Property
Content Type
X99010
eTMF
String
Specifies name of person or entity who entered a term in a content model ontology.
Creator
Core
Creator
Optional
DCMI
http://purl.org/dc/terms/creator
Annotation Property
Creator
XREF
C43621
eTMF
String
Optional Code indicating mapping of term to an external term in another place (if more than one, each code separated by semi-colon)
Cross Reference
Core
Cross Reference
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C43621
Annotation Property
Cross Reference
X99009
eTMF
String
A data type is a classification identifying one of various types of data, such as string, date, integer or boolean, that determines the possible values for that type of value.
DataType
Core
DataType
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#DataType
Annotation Property
DataType
Metadata
X99003
eTMF
String
Data Properties are similar to XML attributes. They are used to define the attributes of Content Types. For more, refer to the general description at: http://www.w3.org/TR/owl2-syntax/#Data_Properties
Data Property
Core
Data Property
Required If Applicable
Metadata
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Property
Annotation Property
Data Property
C42777
eTMF
String
A concise explanation of the meaning of a Category or Data Property.
Definition
Core
Definition
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42777
Annotation Property
Definition
C43682
eTMF
Provides an alternative Preferred Name. For use by software or systems to provide a localized display name. By default, Display Name is the same as Preferred Name.
String
Provides an alternative to Preferred Name. For use by software or systems to provide a localized display name. By default, Display Name is the same as Preferred Name.
Display Name
Core
Display Name
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C43682
Annotation Property
Display Name
C45561
eTMF
String
Used only in OWL RDF/XML file. An identifying marker attached to a Category, Content Type, Data Property or Annotation Property. Label is always the same as Preferred Name and cannot be changed.
Label
Core
Label
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C45561
Annotation Property
Label
X99011
eTMF
String
Used in Ontology to indicate which metadata or data property attributes are assigned to a given content type. Metadata attributes are assigned to Content Types in RDF/XML separated by semi-colons.
Metadata
Core
Metadata
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Metadata
Annotation Property
Metadata
X99006
eTMF
String
Metadata terms are organized by type. Types of metadata are: Core metadata, Business Process Metadata, Domain Specific metadata, General Metadata, Organization Specific. Metadata Types are detailed in the CareLex specification publication.
Metadata Type
Core
Metadata Type
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Metadata_Type
Annotation Property
Core; Business Process; Domain; General; Organization
Metadata Type
X99020
eTMF
String
Metadata that is not required for a content type, but is included to provide additional information or details. There are no limitations on the metadata term source or attributes.
Optional Metadata
Core
Optional Metadata
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Optional_Metadata
Annotation Property
Optional Metadata
C43707
eTMF
String
The word or phrase used by preference to refer to an entity or a term, including Category, Content Type, Data Property, Annotation Property, Organization, and Person.
Preferred Name
Core
Preferred Name
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C43707
Annotation Property
Preferred Name
Reg
C68821
eTMF
String
Specifies agency regulatory Code Section that corresponds to a Content Type requirement- for example, FDA CFR 21 part 11, ICH 5.1.1. Multiple Code sections are separated by semi-colon characters.
Regulation
Core
Regulation
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C68821
Annotation Property
Regulation
Content Repository
C16143
eTMF
String
A digital library in which collections, or archives, of content items are stored in digital format. File based or database. Child entities = Archive
Repository
Core
Repository
Required If Applicable
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C16143
Annotation Property
Repository
C25652
eTMF
String
For a Content Type, specifies whether the Content Type is required by a regulatory agency or to satisfy organization requirements. Does not apply where content type = category. Valid values: Required, Optional, Required if Applicable
Requirement
Core
Requirement
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25652
Annotation Property
Required; Optional; Required if Applicable
Requirement
C25692
eTMF
String
A classification of content within a parent Category. May have zero or more Content Types as children. Has zero or more SubCategories. Child of Category.
SubCategory
Core
SubCategory
Required If Applicable
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25692
Annotation Property
SubCategory
C52469
eTMF
String
Synonyms for the Category, Content Type, Data Property or Annotation Property
Synonym
Core
Synonym
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C52469
Annotation Property
Synonym
C43822
eTMF
String
An indicator of the particular group or agency that supplied a specific term.
Term Source
Core
Term Source
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C43822
Annotation Property
Term Source
X99000
eTMF
String
Indicates URL where term is defined and maintained. Organization specific terms do not require Term Source URL.
Term Source URL
Core
Term Source URL
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Term_Source_URL
Annotation Property
Term Source URL
C42737
eTMF
String
The type of term – Valid values: Primary Category, SubCategory, Content Type, Data Property, Annotation Property, Entity
Term Type
Core
Term Type
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42737
Annotation Property
Primary Category; SubCategory; Content Type
Term Type
X99007
eTMF
String
A value set is a fixed set of data values that can be selected for a given data property attribute. The value set helps ensure data entry accuracy for a given data property field. For example, the data property Organization Role may have a value set of: sponsor, investigator, CRO. The data property attribute could be assigned one of these value set values.
Value Set
Core
Value Set
Required If Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Value_Set
Annotation Property
Value Set
X00003
C.Schmidt CareLex
Business Process Metadata: Recommended metadata for Content Types to provide support for Business Process Modeling and extended auditing. Based on BPMN standard notation
Business Process
Business Process
Term Source URL: http://www.CareLex.org/2012/carelex.owl#Business_Process
Business Process
C99023
eTMF
C.Schmidt CareLex
String
The unique identifier for a piece of content such as a document, image, or other media in a specified context.
Content Identifier
Core
Content Identifier
Required
Content ID
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C99023
Data Property
Content Identifier
X90000
eTMF
C.Schmidt CareLex
String
Content Type Name
The name of the content type. A content type is a reusable collection of metadata, workflow, behavior, and other settings for a category of items in electronic content material.
Content Type Name
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Content_Type_Name
Data Property
Content Type Name
X00005
C.Schmidt CareLex
Core Metadata is assgned to every Content Type by default.
Core
Core
http://www.CareLex.org/2012/carelex.owl#Core
Core
C25464
eTMF
C.Schmidt CareLex
String
Name of country using ISO 3166-1 alpha-3 country codes- Example: USA
Country
Domain
Country
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25464
Data Property
Country
C42620
eTMF
C.Schmidt CareLex
Date
Created
The date and time the resource was created. For a digital file, this need not match a file-system creation time. For a freshly created resource, it should be close to that time. Later file transfer, copying, and so on, may make the file-system time arbitrarily different.
Core
Created
Required
Date Created
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42620
Data Property
Created
C42628
eTMF
C.Schmidt CareLex
String
Indicates the username of the person who brought the item into existence.
Created By
Core
Created By
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42628
Data Property
Created By
C73925
eTMF
C.Schmidt CareLex
String
Professional credential of Person for study - MD, RN, PhD or other for Person linked to a content item / document
Credential
Domain
Credential
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C73925
Data Property
MD, RN, PhD, MS, MA, BA, MBA
Credential
C25164
eTMF
C.Schmidt CareLex
Date
Date of event or Date in context of the document or content type for an event or task. Can be different than date created. Recommended encoding is ISO-8601, such as YYYY-MM-DD.
Date
Business Process
Date
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25164
Data Property
Date
X90005
eTMF
C.Schmidt CareLex
String
An account of the resource or content item.
Description
General
Description
Optional
DCMI
http://purl.org/dc/elements/1.1/description
Data Property
Description
C80447
eTMF
C.Schmidt CareLex
String
Extra data embedded in a document or metadata linked to a document which identifies and authenticates the signer of a document using public-key encryption. May be a URI or path to digital signature resource or public certificate.
Digital Signature
Business Process
Digital Signature
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C80447
Data Property
Digital Signature
X00007
C.Schmidt CareLex
Domain based metadata: Domain-based metadata is specific to the domain, such as 'eTMF Metadata' for the eTMF domain. The recommended domain-based metadata is shown for each Category.
Domain
Domain
http://www.CareLex.org/2012/carelex.owl#Domain
Domain
C48573
eTMF
Date
To come to a close or end of useable period; termination.
General
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C48573&ns=NCI_Thesaurus
Data Property
Expiration
C42761
eTMF
C.Schmidt CareLex
String
Content Item File Format – e.g., PDF, JPG, GIF, XLS, DOC, DOCX, XLSX, PPT, PPTX; uses filename extension as format
Format
Core
Format
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42761
Data Property
PDF, JPG, GIF, XLS, DOC, DOCX, XLSX, PPT, PPTX
Format
X00006
C.Schmidt CareLex
General metadata: Metadata terms which may be taken from a variety of published term sources such as Dublin Core, NCI Thesaurus, or others. May be applied to a content type at the discretion of the implementor.
General
General
http://www.CareLex.org/2012/carelex.owl#General
General
X90006
eTMF
C. Schmidt
String
A spatial region or named place.
Location
General
Location
Optional
DCMI
http://purl.org/dc/terms/Location
Data Property
Location
C25446
eTMF
C.Schmidt CareLex
Date
The date and time the resource was changed in ISO 8601 format.
Modified
Core
Modified
Required
Modification
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25446
Data Property
Modified
C42629
eTMF
C.Schmidt CareLex
String
Indicates the username of the person who changed an item
Modified By
Core
Modified By
Required
Modifier
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42629
Data Property
Modified By
C93874
eTMF
C.Schmidt CareLex
String
The full name of the Organization who linked to the resource.
Organization
Business Process
Organization
Required
Organization Name
NCI
ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C93874
Data Property
Organization
Org Role
X90004
eTMF
C.Schmidt CareLex
String
Denotes Organization Role of Organization who is responsible for or linked to the Content Item. Value set - for example: Sponsor, Site, CRO, Vendor.
Organization Role
Business Process
Organization Role
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Organization_Role
Data Property
Organization Role
C25191
eTMF
C.Schmidt CareLex
String
The full name of the person who performed the workflow action (e.g., approved or submitted a document) or the person to whom this document is linked.
Person
Business Process
Person
Optional
Person Name, Contact Name
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25191
Data Property
Person
X90003
eTMF
C.Schmidt CareLex
String
Role of person who is responsible for or linked to content item. For example: Principal Investigator, SubInvestigator, Study Coordinator, Sponsor Project Manager, CRO Project Manager, Data Manager
Person Role
Business Process
Person Role
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Person_Role
Data Property
Principal Investigator, SubInvestigator, Study Coordinator, Sponsor Project Manager, CRO Project Manager, Data Manager, Other
Person Role
X90002
eTMF
C. Schmidt
String
A sequence or flow of Activities in an organization with the objective of carrying out work. (source: BPMN V 2.0 spec). Tasks are atomic activities that are included within a Process
Process
Business Process
Process
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Process
Data Property
Process
C83081
eTMF
C.Schmidt CareLex
String
A sequence of characters used to identify, name, or characterize the study site.
Site ID
Domain
Site ID
Optional
Study Site Identifier
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C83081
Data Property
Site ID
C25683
eTMF
C.Schmidt CareLex
String
Where the content item is from or its origin. Example values: Archive Import Scan, Fax, email, system, other
Source
Business Process
Source
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C25683
Data Property
Archive, Import, Scan, Fax, Email, System , Other
Source
C83082
eTMF
C.Schmidt CareLex
String
A sequence of characters used to identify, name, or characterize the study.
Study ID
Domain
Study ID
Required
Study Identifier
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C83082
Data Property
Study ID
C69258
eTMF
C. Schmidt
String
A Subject Identifier is a unique sequence of characters used to identify, name, or characterize the study subject individual in a clinical trial study.
Subject Identifier
Business Process
Subject Identifier
Optional
Subject ID
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C69258
Data Property
Subject Identifier
C49106
eTMF
String
An affix occurring at the end of a word, word base, phrase, or name.
General
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C49106&ns=NCI_Thesaurus
Data Property
Suffix
X90001
eTMF
C. Schmidt
String
A single activity that has occurred within a business process. Generally, an end-user, an application, or both will perform the Task. Concept derives from BPMN V2.0. Example tasks are Submission, Approval, Review. Each task is captured in a single record of the business process metadata history log. Example values: Submitted, Approved, Declined, Signed
Task
Business Process
Task
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Task
Data Property
Task
X90007
eTMF
C. Schmidt
String
A name given to the resource or content item.
Title
General
Title
Optional
DCMI
http://purl.org/dc/elements/1.1/title
Data Property
Title
X90008
eTMF
C. Schmidt
String
The nature or genre of the resource or content item.
Type
General
Type
Optional
DCMI
http://purl.org/dc/elements/1.1/type
Data Property
Type
C42778
eTMF
C. Schmidt
String
A character string that can identify any kind of resource on the Internet, including images, text, video, audio and programs. The most commom type of a URI is a URL.
URI
Core
URI
Required
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C42778
Data Property
URI
C42694
eTMF
C.Schmidt CareLex
String
The account name used by a person to access a computer system.
Username
Business Process
Username
Required
User Name
NCI
http://www.CareLex.org/2012/carelex.owl#Username
Data Property
Username
C83101
eTMF
C. Schmidt
String
The numerical identifier of the visit.
Visit Number
Domain
Visit Number
Optional
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C83101
Data Property
Visit Number
X90009
eTMF
String
Specifies whether a document or content item has been digitally signed. If no signature is required, status = null
Business Process
Required
eSign Status
CareLex
http://www.CareLex.org/2012/carelex.owl#Digital_Signature_Status
Data Property
False; Null; True
Digital Signature Status
Acceptance_of_Investigator_Brochure
T104.11.10
X10085
eTMF
C.Schmidt CareLex
084
To document that IB was sent and received.
Acceptance of Investigator Brochure
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Acceptance of Investigator Brochure
Optional
IB Receipt Confirmation, IB signature page
CareLex
http://www.CareLex.org/2012/carelex.owl#Acceptance_of_Investigator_Brochure
Content Type
Acceptance of Investigator Brochure
Additional_Monitoring_Activity
T104.11.34
X10109
eTMF
C.Schmidt CareLex
109
To document additional monitoring activity such as co-visits and Sponsor-specific monitoring activities
Additional Monitoring Activity
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Additional Monitoring Activity
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Additional_Monitoring_Activity
Content Type
Additional Monitoring Activity
Adjudication_Committee_Document
Adj Comm
T100.12.13
X10024
eTMF
C.Schmidt CareLex
021
To describe in advance the decision-making process of the Committee that will evaluate key trial events (e.g. endpoints).
Adjudication Committee Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Adjudication Committee Document
ICH 5.5.2
Required if Applicable
End Point Committee Document
CareLex
http://www.CareLex.org/2012/carelex.owl#Adjudication_Committee_Document
Content Type
Adjudication Committee Document
Analysis
110.12
C25391
eTMF
Analysis
Analysis
CareLex
http://www.CareLex.org/2012/carelex.owl#Analysis
SubCategory
Analysis
Analysis_QC_Documentation
T110.12.11
X10261
eTMF
218
To confirm the QC procedures planned for the analysis programs as well as the actual output of the QC steps.
Analysis QC Documentation
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Analysis QC Documentation
ICH 5.1, 5.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Analysis_QC_Documentation
Content Type
Analysis QC Documentation
Annotated_Case_Report_Form
T109.11.11
X10228
eTMF
C.Schmidt CareLex
188
To provide detailed instructions on how data points on each CRF are to be completed; how to enter on paper and if EDC, how to enter data into the system.
Annotated Case Report Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Annotated Case Report Form
ICH 5.1, 5.5
Optional
Annotated CRF, CRF Completion Guidelines
CareLex
http://www.CareLex.org/2012/carelex.owl#Annotated_Case_Report_Form
Content Type
Annotated Case Report Form
Approval
T102.10.11
C25425
eTMF
C.Schmidt CareLex
053
A document received from a regulatory authority stating that the Submission has been received and approved.
Approval
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Approval
ICH 8.2.9, 8.3.4
Required if Applicable
Letter of Authorization
CareLex
http://www.CareLex.org/2012/carelex.owl#Approval
Content Type
Approval
Approval_for_Database_Activation
T109.12.14
X10236
eTMF
196
To provide documentation that all requirements of the database specification have been satisfied, and data entry can begin (go live); will also include confirmation that data validation testing has been successfully completed.
Approval for Database Activation
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Approval for Database Activation
ICH 5.1, 5.5
Required
Database Release Approval, Approval for Database Go Live
CareLex
http://www.CareLex.org/2012/carelex.owl#Approval_for_Database_Activation
Content Type
Approval for Database Activation
Audit_Certificate
Aud Cert
T100.10.23
X10015
eTMF
C.Schmidt CareLex
014
To document that an audit was performed. (Does not contain the audit report.) Site specific audit certificate filed under investigator documents.
Audit Certificate
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Audit Certificate
ICH 8.4.4
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Audit_Certificate
Content Type
Audit Certificate
Bioanalytical_Reports
T107.10.12
X10197
eTMF
C.Schmidt CareLex
162
Summary listings or individual subject reports provided by the laboratory or other testing facility, e.g. results of biochemical testing, histological examination.
Bioanalytical Reports
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Bioanalytical Reports
ICH 8.2.12, 8.3.8
Required if Applicable
Bioanalytical Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Bioanalytical_Reports
Content Type
Bioanalytical Reports
Bioanalytical_Validation_Methods
T107.10.11
X10196
eTMF
C.Schmidt CareLex
161
To document through use of control data that a laboratory can consistently and reproducibly report results that are reliable; may include but is not limited to reporting of calibration and control results for a research test parameter, antibody or pharmacokinetic testing that may be performed by an internal or external laboratory; required if certification or accreditation is not available for the study test method.
Bioanalytical Validation Methods
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Bioanalytical Validation Methods
ICH 8.2.12, 8.3.7
Required if Applicable
Method validation, quality control testing, precision testing
CareLex
http://www.CareLex.org/2012/carelex.owl#Bioanalytical_Validation_Methods
Content Type
Bioanalytical Validation Methods
CRF_Completion_Requirements
T109.11.10
X10227
eTMF
C.Schmidt CareLex
187
To provide detailed instructions on how data points on each CRF are to be completed; how to enter on paper and if EDC, how to enter data into the system.
CRF Completion Requirements
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
CRF Completion Requirements
ICH 1.46, 5.1, 5.5
Required
CRF Completion Guidelines
CareLex
http://www.CareLex.org/2012/carelex.owl#CRF_Completion_Requirements
Content Type
CRF Completion Requirements
Case_Report_Form
CRF
T101.10.16
C40988
eTMF
C.Schmidt CareLex
037
Blank forms / templates in paper form or e-Format to capture the data points of the protocol.
Case Report Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Case Report Form
ICH 8.2.2, 8.3.2
Required
Sample Case Report Form, CRF/eCRF, Sample CRF/eCRF
CareLex
http://www.CareLex.org/2012/carelex.owl#Case_Report_Form
Content Type
Case Report Form
Central_Trial_Documents
101
X10036
eTMF
C.Schmidt CareLex
General Study Documents - not study site specific
Central Trial Documents
Central Trial Documents
CareLex
http://www.CareLex.org/2012/carelex.owl#Central_Trial_Documents
Primary Category
Central Trial Documents
Central_Trial_Final_Reports
101.12
X10049
eTMF
C.Schmidt CareLex
To describe final or interim results and interpretation of trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report; contains data listings and summaries.
Central Trial Final Reports
Central Trial Final Reports
Reports
CareLex
http://www.CareLex.org/2012/carelex.owl#Central_Trial_Final_Reports
SubCategory
Central Trial Final Reports
Centralized_Testing
107
X10193
eTMF
C.Schmidt CareLex
Documents related to central laboratory research and reporting for clinical trials.
Centralized Testing
Centralized Testing
CareLex
http://www.CareLex.org/2012/carelex.owl#Centralized_Testing
Primary Category
Centralized Testing
Certificate_of_Analysis
T105.11.13
X10156
eTMF
C.Schmidt CareLex
132
To document identity, purity, and strength of the IP(s) to be used trial, in accordance with the specifications of the IP, including the acceptance limits and the actual results of the tests.
Certificate of Analysis
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Certificate of Analysis
ICH 2.12, 5.13.5, 8.2.16, 8.3.9
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Certificate_of_Analysis
Content Type
Certificate of Analysis
Certificate_of_Destruction
T105.10.20
X10151
eTMF
C.Schmidt CareLex
128
To document the confirmation of destruction of IP at the end of a trial at a distribution center, depot, and/or site.
Certificate of Destruction
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Certificate of Destruction
ICH 5.14.4
Required
Documentation of Destruction
CareLex
http://www.CareLex.org/2012/carelex.owl#Certificate_of_Destruction
Content Type
Certificate of Destruction
Clinical_Study_Report
Cln Study Rpt
T101.12.10
C79176
eTMF
C.Schmidt CareLex
045
To describe final or interim results and interpretation of trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report; contains data listings and summaries.
Clinical Study Report
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Clinical Study Report
ICH 1.13, 8.4.8
Required
Integrated Clinical & Statistical Report, Abbreviated Clinical Study Report, CSR, Legacy CSR, Report Body
CareLex
http://www.CareLex.org/2012/carelex.owl#Clinical_Study_Report
Content Type
Clinical Study Report
Clinical_Study_Report_Synopsis
Clin Study Rpt Syn
T101.12.11
X10050
eTMF
C.Schmidt CareLex
046
A short summary of the study results taken from the full Clinical Study Report, primarily prepared for submission to regulatory bodies and/or IEC/IRBs.
Clinical Study Report Synopsis
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Clinical Study Report Synopsis
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Clinical_Study_Report_Synopsis
Content Type
Clinical Study Report Synopsis
Clinical_Trial_Agreement
T104.11.21
X10096
eTMF
C.Schmidt CareLex
095
To document agreement of trial requirements between sponsor or 3rd Party and site/ PI. Includes indemnity unless separate document created.
Clinical Trial Agreement
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Clinical Trial Agreement
ICH 8.2.4, 8.2.6
Required
Clinical Study Agreement, Investigator Financial Agreement
CareLex
http://www.CareLex.org/2012/carelex.owl#Clinical_ Trial_Agreement
Content Type
Clinical Trial Agreement
Clinical_Trial_Oversight_Committees
100.12
X10020
eTMF
C.Schmidt CareLex
A group delegated to consider some matter; a self-constituted organization to promote something related to a clinical trial.
Clinical Trial Oversight Committees
Clinical Trial Oversight Committees
Committees
CareLex
http://www.CareLex.org/2012/carelex.owl#Clinical_Trial_Oversight_Committees
SubCategory
Clinical Trial Oversight Committees
Communication_Plan
Comms Plan
T100.10.16
X10008
eTMF
C.Schmidt CareLex
007
To document communication strategy and plans between trial stakeholders.
Communication Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Communication Plan
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Communication_Plan
Content Type
Communication Plan
Completed_Case_Report_Forms
T109.11.12
X10229
eTMF
C.Schmidt CareLex
189
A document which contains the available protocol-required information to be reported to the sponsor for each subject in the clinical trial; associated documents may include but is not limited to documentation of CRF corrections, subject diaries, questionnaires, laboratory reports and other third-party specialty data.
Completed Case Report Forms
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Task
Completed Case Report Forms
ICH 5.1, 5.5, 8.3.14
Required
Completed CRFs
CareLex
http://www.CareLex.org/2012/carelex.owl#Completed_Case_Report_Forms
Content Type
Completed Case Report Forms
Computed_Tomography
CT
111.13
C17204
eTMF
C.Schmidt CareLex
Subject Tomography for a specific study.
Computed Tomography
Computed Tomography
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C17204
SubCategory
Computed Tomography
Contractual_Agreement
T108.11.12
X10217
eTMF
C.Schmidt CareLex
180
To document by a written dated signed agreement between two or more parties that defines any arrangements on delegation and distribution of tasks and obligations; critical components include service description, responsibilities matrix and budget.
Contractual Agreement
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Contractual Agreement
ICH 1.17, 8.2.6
Required if Applicable
Scope of Work, Project Work Order, Change Order, Financial Agreement, Contract, Service Agreement, Letter of Agreement, Authorization to Proceed
CareLex
http://www.CareLex.org/2012/carelex.owl#Contractual_Agreement
Content Type
Contractual Agreement
Core_Trial_Documents
101.10
X10037
eTMF
C.Schmidt CareLex
Core clinical trial document templates and forms, not subject specific, such as Protocol, Investigator Brochure, Protocol Synopsis, Sample Case Report Form
Core Trial Documents
Core Trial Documents
Trial Documents
CareLex
http://www.CareLex.org/2012/carelex.owl#Core_Trial_Documents
SubCategory
Core Trial Documents
Data_Capture
109.11
X10226
eTMF
C.Schmidt CareLex
Documents describing processes to capture, enter, store and retrieve clinical trial data
Data Capture
Data Capture
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Capture
SubCategory
Data Capture
Data_Clarification_Forms
T109.11.13
X10230
eTMF
C.Schmidt CareLex
190
Any documentation used to query database discrepancies and to record approved corrections to the clinical trial database; includes self-evident corrections, laboratory queries and any other database queries generated.
Data Clarification Forms
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Task
Data Clarification Forms
ICH 4.9.3, 5.5, 8.3.15
Required
Documentation of Corrections to Entered Data, Data Correction Forms, Data Query Forms, Documentation of Corrections to Entered Data
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Clarification_Forms
Content Type
Data Clarification Forms
Data_Definitions_for_Analysis_Datasets
T110.12.10
X10260
eTMF
217
To define the programming logic required to transform the raw dataset to the analysis dataset; includes populations, etc; as outlined in the SAP.
Data Definitions for Analysis Datasets
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Data Definitions for Analysis Datasets
ICH 5.1, 5.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Definitions_for_Analysis_Datasets
Content Type
Data Definitions for Analysis Datasets
Data_Entry_Guidelines
T109.12.16
X10238
eTMF
198
To provide detailed instructions on how CRF data is to be entered into a database; specific to a paper CRF trial (therefore, would not be required with an EDC trial), including self-evident corrections and global conventions.
Data Entry Guidelines
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Data Entry Guidelines
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Entry_Guidelines
Content Type
Data Entry Guidelines
Data_Management
109
C18086
eTMF
C.Schmidt CareLex
Data Management
Data Management
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Management
Primary Category
Data Management
Data_Management_Oversight
109.10
X10224
eTMF
C.Schmidt CareLex
Documents related to operating procedures for clinical trial data acquisition, validation, storage, protection, and processing.
Data Management Oversight
Data Management Oversight
Data Management
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Management_Oversight
SubCategory
Data Management Oversight
Data_Management_Plan
T109.10.10
X10225
eTMF
C.Schmidt CareLex
186
To identify the overall strategy for data management process: a compilation of documents that may include but are not limited to: Completion Guidelines, Database (build) Specification, Entry Guidelines, Database Testing; most if not all content types are listed in the Data Management Category.
Data Management Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Data Management Plan
ICH 5.1, 5.5
Optional
Data Management Operational Plan, Technology Plan, Data Management Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Management_Plan
Content Type
Data Management Plan
Data_Privacy_Agreement
T104.11.20
X10095
eTMF
C.Schmidt CareLex
094
To document agreement between Sponsor and Site Staff (EU); often contained in Clinical Trial Agreement
Data Privacy Agreement
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Data Privacy Agreement
Optional
Personal Data Consent
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Privacy_Agreement
Content Type
Data Privacy Agreement
Data_Validation_Certification
T109.12.21
X10243
eTMF
203
To confirm that the data validation programming has been done correctly and it accurately validates data as per the data validation plan.
Data Validation Certification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Data Validation Certification
ICH 5.1, 5.5
Required
EDC UAT Sign Off; EDC Validation Certification
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Validation_Certification
Content Type
Data Validation Certification
Data_Validation_Plan
T109.12.11
X10233
eTMF
C.Schmidt CareLex
193
To define edit checks and the process for edit check / validation testing for Database Specification, may include what test data is to be used.
Data Validation Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Data Validation Plan
ICH 5.1, 5.5
Required
Data integration, Edit Check and Logic Check Specifications, EDC Validation including Validation Test Plan, Data Validation Specification
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Validation_Plan
Content Type
Data Validation Plan
Data_Validation_Testing
T109.12.13
X10235
eTMF
C.Schmidt CareLex
195
To provide evidence that the data validation has been implemented correctly and it accurately validates data as per the data validation plan.
Data Validation Testing
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Data Validation Testing
ICH 5.1, 5.5
Required
Edit Check Validation, Data Validation Database Specification QC
CareLex
http://www.CareLex.org/2012/carelex.owl#Data_Validation_Testing
Content Type
Data Validation Testing
Database
109.12
C15426
eTMF
C.Schmidt CareLex
An information set with a regular structure; a database for electronic data capture of data in a clinical trial.
Database
Database
CareLex
http://www.CareLex.org/2012/carelex.owl#Database
SubCategory
Database
Database_Account_Management
T109.13.10
X10245
eTMF
C.Schmidt CareLex
204
To capture account management details for all team members who will need to have access to the system. Includes EDC
Database Account Management
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Database Account Management
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Database_Account_Management
Content Type
Database Account Management
Database_Lock_and_Unlock_Approval
T109.12.20
X10242
eTMF
202
Confirmation that all of the requirements for database release have been meet; may include all unlock and re-lock documentation.
Database Lock and Unlock Approval
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Database Lock and Unlock Approval
ICH 5.1, 5.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Database_Lock_and_Unlock_Approval
Content Type
Database Lock and Unlock Approval
Database_Quality_Plan
T109.12.19
X10241
eTMF
201
To define the procedures for creating and implementing a Quality Control (QC) Plan to ensure that quality data is captured into a clinical database on an ongoing basis. This would include any documentation of the results from the plan.
Database Quality Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Database Quality Plan
ICH 5.1, 5.5
Required
Database QC / QA Plan & Results, QC/QA Database Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Database_Quality_Plan
Content Type
Database Quality Plan
Database_Specification
T109.12.10
X10232
eTMF
C.Schmidt CareLex
192
To provide a detailed framework to database designers on how a database is to be built for paper and EDC; design requirements for the build of the database; for EDC studies, user requirements may be included; also includes maintenance and archiving guidelines.
Database Specification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Database Specification
ICH 1.46, 5.1, 5.5
Required
Database Programming Requirements
CareLex
http://www.CareLex.org/2012/carelex.owl#Database_Specification
Content Type
Database Specification
Debarment_Statement
Debar Stmt
T100.10.20
X10012
eTMF
C.Schmidt CareLex
011
To certify whether the applicant, or any of its principals, is currently debarred, suspended, proposed for debarment, or declared ineligible to receive federal awards; whether within the past three years the applicant, or any of its principals, has been convicted of or had a civil judgment rendered against it for, or been indicted for, commission of fraud or certain criminal offenses; and whether the applicant has had any federal award terminated for cause or default in the past three years. Often part of the site qualification process.
Debarment Statement
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Debarment Statement
Optional
Debarment Certification
CareLex
http://www.CareLex.org/2012/carelex.owl#Debarment_Statement
Content Type
Debarment Statement
Dictionary_Coding
T109.12.18
X10240
eTMF
200
To document the process and tools used in medical coding; includes medical sign off of coding; may include resolution discrepancies.
Dictionary Coding
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Dictionary Coding
ICH 5.1, 5.5
Required
Medical Coding
CareLex
http://www.CareLex.org/2012/carelex.owl#Dictionary_Coding
Content Type
Dictionary Coding
Digital_Photographs
111.10
C19342
eTMF
C.Schmidt CareLex
Digital photos and images for study or study subjects
Digital Photographs
Digital Photographs
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C19342
SubCategory
Digital Photographs
Dose_Escalation
Dose Esc
T100.12.15
X10026
eTMF
C.Schmidt CareLex
023
To document all correspondence and decisions regarding dose escalation, including approvals to move to the next dosing level.
Dose Escalation
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Dose Escalation
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Dose_Escalation
Content Type
Dose Escalation
EDC_Management
109.13
X10244
eTMF
C.Schmidt CareLex
Management of the Electronic Data Capture (EDC) system
EDC Management
EDC Management
CareLex
http://www.CareLex.org/2012/carelex.owl#EDC_Management
SubCategory
EDC Management
Edit_Check_Programming
T109.12.12
X10234
eTMF
C.Schmidt CareLex
194
To provide the code which satisfies the edit check specification details in data validation plan; may include a reference to where the code resides.
Edit Check Programming
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Edit Check Programming
ICH 5.1, 5.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Edit_Check_Programming
Content Type
Edit Check Programming
Electronic_Data_Capture_Final_Data
T109.11.14
X10231
eTMF
C.Schmidt CareLex
191
Final Electronic Data Capture data for the protocol.
Electronic Data Capture Final Data
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Task
Electronic Data Capture Final Data
ICH 8.3.14
Required if Applicable
Final EDC Data
CareLex
http://www.CareLex.org/2012/carelex.owl#Electronic_Data_Capture_Final_Data
Content Type
Electronic Data Capture Final Data
End_of_Trial
T110.11.15
X10259
eTMF
216
To document and authorize the release of the randomization code and allow the trial data to be unblinded. Includes evidence of release of end of trial unblinding
End of Trial
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
End of Trial
ICH 5.1, 5.5
Required
Decoding Request, Randomization Release Request
CareLex
http://www.CareLex.org/2012/carelex.owl#End_of_Trial
Content Type
End of Trial
Evidence_of_Contractor_Compliance_
T108.10.10
X10213
eTMF
C.Schmidt CareLex
177
To confirm that a third party meets, and continues to meet throughout the study, all relevant criteria to fulfill a contractual obligation; may include a quality questionnaire, a visit report to qualify their capabilities, other documents that support capabilities.
Evidence of Contractor Compliance
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Evidence of Contractor Compliance
Required if Applicable
Documentation of Decision to Utilize Third Party, Qualification of Vendor, Audit Certificate
CareLex
http://www.CareLex.org/2012/carelex.owl#Evidence_of_Contractor_Compliance
Content Type
Evidence of Contractor Compliance
Expedited_Safety_Report
T106.11.10
X10184
eTMF
C.Schmidt CareLex
152
To assure notification by the sponsor of unexpected serious adverse drug reactions and other safety information; submitted to regulatory authorities and IRBs/IECs. Reports may include but are not limited to CIOMS, MedWatch, Electronic Submission of AE Notification to FDA Reports, Analysis of Similar Events, cover letters, and/or country-specific reporting forms.
Expedited Safety Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Expedited Safety Report
ICH 5.16.2, 5.17, 8.3.17-18
Required if Applicable
CIOMS Report, MedWatch, Investigational New Drug (IND) Safety Report, Suspected Unexpected Serious Adverse Reaction (SUSAR)
CareLex
http://www.CareLex.org/2012/carelex.owl#Expedited_Safety_Report
Content Type
Expedited Safety Report
External_Data_Transfer_Specifications
T109.12.15
X10237
eTMF
197
To document import and export data specifications; includes but is not limited to diary, lab, IVRS, imaging; may include transfer from one group to another; may also include data transfer from IVRS to EDC.
External Data Transfer Specifications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
External Data Transfer Specifications
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#External_Data_Transfer_Specifications
Content Type
External Data Transfer Specifications
Facility_Documentation
107.10
X10194
eTMF
C.Schmidt CareLex
Certifications and or accreditation for central laboratory for a clinical trial
Facility Documentation
Facility Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Facility_Documentation
SubCategory
Facility Documentation
Feasibility_Documentation
T104.10.12
X10081
eTMF
C.Schmidt CareLex
081
To document site feasibility for the given protocol.
Feasibility Documentation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Feasibility Documentation
Optional
Site Selection Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Feasibility_Documentation
Content Type
Feasibility Documentation
Filenote_Master_List
Filent Mstr List
T100.10.24
X10016
eTMF
C.Schmidt CareLex
015
To provide a consolidated list/index of file notes generated during the trial. (may not be needed with eTMF)
Filenote Master List
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Filenote Master List
Optional
Note to File Master List
CareLex
http://www.CareLex.org/2012/carelex.owl#Filenote_Master_List
Content Type
Filenote Master List
Final_Analysis_Datasets
T110.12.18
X10268
eTMF
225
The datasets used for the final analysis.
Final Analysis Datasets
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Final Analysis Datasets
ICH 5.1, 5.5
Required
Analysis Datasets
CareLex
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Datasets
Content Type
Final Analysis Datasets
Final_Analysis_Output
T110.12.19
X10269
eTMF
226
The Tables, Listings and Figures produced from the final analysis datasets; includes Statistics approval. May be appended to the CSR.
Final Analysis Output
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Final Analysis Output
ICH 5.1, 5.5
Required
Statistical Output
CareLex
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Output
Content Type
Final Analysis Output
Final_Analysis_Programs
T110.12.17
X10267
eTMF
224
The suite of programs designed to generate the final analysis outputs as referenced in the SAP.
Final Analysis Programs
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Final Analysis Programs
ICH 5.1, 5.5
Required
Program File for Analysis Dataset
CareLex
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Programs
Content Type
Final Analysis Programs
Final_Analysis_Raw_Datasets
T110.12.16
X10266
eTMF
223
The export of raw data for final analysis purposes.
Final Analysis Raw Datasets
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Final Analysis Raw Datasets
ICH 5.1, 5.5
Required
Datasets
CareLex
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Raw_Datasets
Content Type
Final Analysis Raw Datasets
Final_Trial_Close_Out_Monitoring_Report
T104.11.37
X10112
eTMF
C.Schmidt CareLex
112
To document trial activities are completed for site closure prior to trial completion.
Final Trial Close Out Monitoring Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Final Trial Close Out Monitoring Report
ICH 8.4.5
Required
Close Out Visit Report, Close Out Monitoring Visit Report
CareLex
http://www.CareLex.org/2012/carelex.owl#Final_Trial_Close_Out_Monitoring_Report
Content Type
Final Trial Close Out Monitoring Report
Financial_Disclosure_Form
FD
T104.11.19
X10094
eTMF
C.Schmidt CareLex
093
To certify that no financial arrangements with an investigator have been made where study outcome could affect compensation; that the investigator has no proprietary interest in the tested product; that the investigator does not have a significant equity interest in the sponsor of the covered study; and that the investigator has not received significant payments of other sorts; and/or disclosure of specified financial arrangements and any steps taken to minimize the potential for bias.
Financial Disclosure Form
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Financial Disclosure Form
ICH 8.2.4
Required if Applicable
Financial Disclosure Information
CareLex
http://www.CareLex.org/2012/carelex.owl#Financial_Disclosure_Form
Content Type
Financial Disclosure Form
Financial_Disclosure_Summary
FD Summary
T101.10.14
X10041
eTMF
C.Schmidt CareLex
035
Summary documentation of compliance with financial disclosure reporting requirements. May include summaries, lists, other reports.
Financial Disclosure Summary
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Financial Disclosure Summary
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Financial_Disclosure_Summary
Content Type
Financial Disclosure Summary
Financial_Documentation
T104.11.36
X10111
eTMF
C.Schmidt CareLex
111
Includes all invoices, receipts, payment summaries relating to the trial
Financial Documentation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Financial Documentation
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Financial_Documentation
Content Type
Financial Documentation
Form_FDA_1572
1572
T104.11.17
X10092
eTMF
C.Schmidt CareLex
091
For IND trial, 1572 must be completed globally for FDA submission.
Form FDA 1572
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Form FDA 1572
ICH 8.2.6
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Form_FDA_1572
Content Type
Form FDA 1572
General_Central_Trial_Communications
GCTrial Comms
T101.13.10
X10053
eTMF
C.Schmidt CareLex
048
General Central Trial Communications agreements, significant discussions or relevant information, but not specifically listed. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Central Trial Communications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Central Trial Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Communications
Content Type
General Central Trial Communications
General_Central_Trial_Documents
101.13
X10052
eTMF
C.Schmidt CareLex
General Central Trial Documents otherwise unspecified.
General Central Trial Documents
General Central Trial Documents
General
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Documents
SubCategory
General Central Trial Documents
General_Central_Trial_Filenote
GCTrial File
T101.13.13
X10056
eTMF
C.Schmidt CareLex
051
General Central Trial notes to file to document any decision or to clarify any information relating to the Central Trial category.
General Central Trial Filenote
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Central Trial Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Filenote
Content Type
General Central Trial Filenote
General_Central_Trial_Meeting_Material
GCTrial Mtg Matl
T101.13.12
X10055
eTMF
C.Schmidt CareLex
050
General Central Trial Meeting Agendas, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Central Trial Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Central Trial Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Meeting_Material
Content Type
General Central Trial Meeting Material
General_Central_Trial_Tracking_Document
GCTrial Tracking
T101.13.11
X10054
eTMF
C.Schmidt CareLex
049
General Central Trial Tracking documents developed for the purpose of tracking activities during the course of the trial.
General Central Trial Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Central Trial Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Tracking_Document
Content Type
General Central Trial Tracking Document
General_Centralized_Meeting_Material
T107.12.12
X10210
eTMF
C.Schmidt CareLex
175
General Centralized Testing Agenda, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Centralized Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Centralized Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Meeting_Material
Content Type
General Centralized Meeting Material
General_Centralized_Testing
107.12
X10207
eTMF
C.Schmidt CareLex
General Centralized Testing documents, otherwise unspecified
General Centralized Testing
General Centralized Testing
General Centralized Testing documents otherwise unspecified
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Testing
SubCategory
General Centralized Testing
General_Centralized_Testing_Communications
T107.12.10
X10208
eTMF
C.Schmidt CareLex
173
General Centralized Testing agreements, significant discussions or relevant information, but not specifically listed. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Centralized Testing Communications
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Centralized Testing Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Testing_Communications
Content Type
General Centralized Testing Communications
General_Centralized_Testing_Filenote
T107.12.13
X10211
eTMF
C.Schmidt CareLex
176
To document any decision or to clarify any information relating to the General Centralized Testing Category.
General Centralized Testing Filenote
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Centralized Testing Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Testing_Filenote
Content Type
General Centralized Testing Filenote
General_Centralized_Tracking_Document
T107.12.11
X10209
eTMF
C.Schmidt CareLex
174
General Centralized Testing documents developed for the purpose of tracking activities during the course of the trial.
General Centralized Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Centralized Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Tracking_Document
Content Type
General Centralized Tracking Document
General_Data_Management
109.14
X10246
eTMF
C.Schmidt CareLex
General Data Management documents, otherwise unspecified
General Data Management
General Data Management
CareLex
http://www.CareLex.org/2012/carelex.owl#EDC_Management
SubCategory
General Data Management
General_Data_Management_Communications
T109.14.10
X10247
eTMF
C.Schmidt CareLex
205
General Data Management agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Data Management Communications
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Data Management Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Communications
Content Type
General Data Management Communications
General_Data_Management_Filenote
T109.14.13
X10250
eTMF
208
To document any decision or to clarify any information relating to the General Data Management Category.
General Data Management Filenote
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Data Management Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Filenote
Content Type
General Data Management Filenote
General_Data_Management_Meeting_Material
T109.14.12
X10249
eTMF
207
General Data Management Agendas, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Data Management Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Data Management Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Meeting_Material
Content Type
General Data Management Meeting Material
General_Data_Management_Tracking_Document
T109.14.11
X10248
eTMF
206
General Data Management documents developed for the purpose of tracking activities during the course of the trial.
General Data Management Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Data Management Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Tracking_Document
Content Type
General Data Management Tracking Document
General_IP_Documents
105.16
X10174
eTMF
C.Schmidt CareLex
General IP and Trial Supplies, otherwise unspecified
General IP Documents
General IP Documents
General
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IP_Documents
SubCategory
General IP Documents
General_IP_and_Trial_Supplies_Communications
T105.16.10
X10175
eTMF
C.Schmidt CareLex
146
General IP and Trial Supplies agreements, significant discussions or relevant information, but not specifically listed. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General IP and Trial Supplies Communications
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General IP and Trial Supplies Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Communications
Content Type
General IP and Trial Supplies Communications
General_IP_and_Trial_Supplies_Filenote
T105.16.13
X10178
eTMF
C.Schmidt CareLex
149
To document any decision or to clarify any information relating to the General IP and Trial Supplies category.
General IP and Trial Supplies Filenote
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General IP and Trial Supplies Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Filenote
Content Type
General IP and Trial Supplies Filenote
General_IP_and_Trial_Supplies_Meeting_Material
T105.16.12
X10177
eTMF
C.Schmidt CareLex
148
General IP and Trial Supplies Meeting Agenda, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General IP and Trial Supplies Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General IP and Trial Supplies Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Meeting_Material
Content Type
General IP and Trial Supplies Meeting Material
General_IP_and_Trial_Supplies_Tracking_Document
T105.16.11
X10176
eTMF
C.Schmidt CareLex
147
General IP and Trial Supplies documents developed for the purpose of tracking activities during the course of the trial.
General IP and Trial Supplies Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General IP and Trial Supplies Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Tracking_Document
Content Type
General IP and Trial Supplies Tracking Document
General_IRB-IEC
103
X10071
eTMF
C.Schmidt CareLex
Set of documents shared between an Institutional Review Board (IRB), independent ethics committee (IEC) or other Committee and a sponsor regarding the conduct of a trial. General IRB documents are trial level documents, not site specific documents. Local IRB-IEC are filed under Site Management, IRB-IEC Documents category.
General IRB-IEC
General IRB-IEC
IRB/IEC and other Approvals
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC
Primary Category
General IRB-IEC
General_IRB-IEC_Communications
T103.10.10
X10073
eTMF
C.Schmidt CareLex
075
General IRB-IEC communications, significant discussions or relevant information. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General IRB-IEC Communications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General IRB-IEC Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Communications
Content Type
General IRB-IEC Communications
General_IRB-IEC_Filenote
T103.10.13
X10076
eTMF
C.Schmidt CareLex
078
To document any decision or to clarify any information relating to the General IRB-IEC and other Committees Sponsor Communications Category.
General IRB-IEC Filenote
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General IRB-IEC Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Filenote
Content Type
General IRB-IEC Filenote
General_IRB-IEC_Meeting_Material
T103.10.12
X10075
eTMF
C.Schmidt CareLex
077
General IRB-IEC related Agenda, presentation materials and other documentation generated during an internal or external meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General IRB-IEC Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General IRB-IEC Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Meeting_Material
Content Type
General IRB-IEC Meeting Material
General_IRB-IEC_Tracking_Document
T103.10.11
X10074
eTMF
C.Schmidt CareLex
076
General IRB-IEC documents developed for the purpose of tracking activities during the course of the trial.
General IRB-IEC Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General IRB-IEC Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Tracking_Document
Content Type
General IRB-IEC Tracking Document
General_Regulatory
102.13
X10066
eTMF
C.Schmidt CareLex
Regulatory documents not otherwise specified
General Regulatory
General Regulatory
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Regulatory
SubCategory
General Regulatory
General_Regulatory_Communications
T102.13.10
X10067
eTMF
C.Schmidt CareLex
061
General Regulatory agreements, significant discussions or relevant information, but not specifically listed. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Regulatory Communications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Regulatory Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Communications
Content Type
General Regulatory Communications
General_Regulatory_Filenote
T102.13.13
X10070
eTMF
C.Schmidt CareLex
064
To document any decision or to clarify any information relating to the General Regulatory Category.
General Regulatory Filenote
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Regulatory Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Filenote
Content Type
General Regulatory Filenote
General_Regulatory_Meeting_Material
T102.13.12
X10069
eTMF
C.Schmidt CareLex
063
General Regulatory Agenda, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Regulatory Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Regulatory Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Meeting_Material
Content Type
General Regulatory Meeting Material
General_Regulatory_Tracking_Document
T102.13.11
X10068
eTMF
C.Schmidt CareLex
062
General Regulatory documents developed for the purpose of tracking activities during the course of the trial.
General Regulatory Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Regulatory Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Tracking_ Document
Content Type
General Regulatory Tracking Document
General_Safety_Communications
T106.12.10
X10189
eTMF
C.Schmidt CareLex
156
General Safety agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Safety Communications
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Safety Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Safety _Communications
Content Type
General Safety Communications
General_Safety_Filenote
T106.12.13
X10192
eTMF
C.Schmidt CareLex
159
To document any decision or to clarify any information relating to the General Safety Category.
General Safety Filenote
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Safety Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Safety_Filenote
Content Type
General Safety Filenote
General_Safety_Meeting_Material
T106.12.12
X10191
eTMF
C.Schmidt CareLex
158
General Safety Category meeting Agenda, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Safety Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Safety Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Safety_Meeting_Material
Content Type
General Safety Meeting Material
General_Safety_Reporting
106.12
X10188
eTMF
C.Schmidt CareLex
Safety Reporting documents, otherwise unspecified
General Safety Reporting
General Safety Reporting
General
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Safety_Reporting
SubCategory
General Safety Reporting
General_Safety_Tracking_Document
T106.12.11
X10190
eTMF
C.Schmidt CareLex
157
General Safety documents developed for the purpose of tracking activities during the course of the trial.
General Safety Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Safety Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Safety_Tracking Document
Content Type
General Safety Tracking Document
General_Site_Management
104.15
X10134
eTMF
C.Schmidt CareLex
General Site Management documents, otherwise unspecified
General Site Management
General Site Management
General
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Site_Management
SubCategory
General Site Management
General_Site_Management_Communications
T104.15.10
X10135
eTMF
C.Schmidt CareLex
114
General Site Management agreements, significant discussions or relevant information, but not specifically listed. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Site Management Communications
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Site Management Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Communications
Content Type
General Site Management Communications
General_Site_Management_Filenote
T104.15.13
X10138
eTMF
C.Schmidt CareLex
117
To document any decision or to clarify any information relating to the General Site Management Category.
General Site Management Filenote
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Site Management Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Filenote
Content Type
General Site Management Filenote
General_Site_Management_Meeting_Material
T104.15.12
X10137
eTMF
C.Schmidt CareLex
116
General Site Management Category meeting Agenda, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Site Management Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Site Management Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Meeting_Material
Content Type
General Site Management Meeting Material
General_Site_Management_Tracking_Document
T104.15.11
X10136
eTMF
C.Schmidt CareLex
115
General Site Management documents developed for the purpose of tracking activities during the course of the trial.
General Site Management Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
General Site Management Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Tracking_Document
Content Type
General Site Management Tracking Document
General_Statistics
110.14
X10274
eTMF
General Statistics documents, otherwise unspecified
General Statistics
General Statistics
General
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Statistics
SubCategory
General Statistics
General_Statistics_Communications
T110.14.10
X10275
eTMF
230
General Statistics agreements, significant discussions or relevant information, but not specifically listed in this Reference Model. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Statistics Communications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Statistics Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Communications
Content Type
General Statistics Communications
General_Statistics_Filenote
T110.14.13
X10278
eTMF
233
To document any decision or to clarify any information relating to the General Statistics Category.
General Statistics Filenote
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Statistics Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Filenote
Content Type
General Statistics Filenote
General_Statistics_Meeting_Material
T110.14.12
X10277
eTMF
232
General Statistics Meeting Agenda, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Statistics Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Statistics Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Meeting_Material
Content Type
General Statistics Meeting Material
General_Statistics_Tracking_Document
T110.14.11
X10276
eTMF
231
General Statistics documents developed for the purpose of tracking activities during the course of the trial.
General Statistics Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Statistics Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Tracking_Document
Content Type
General Statistics Tracking Document
General_Trial_Filenote
GTrial File
T100.14.13
X10035
eTMF
C.Schmidt CareLex
030
General Trial Management Filenotes that document any decision or to clarify any information relating to trial management.
General Trial Filenote
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Trial Filenote
Required if Applicable
Filenote, Note
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Trial_Filenote
Content Type
General Trial Filenote
General_Trial_Management_Communications
GTrial Mgmt Comm
T100.14.10
X10032
eTMF
C.Schmidt CareLex
027
Management Communications for Trial Management, including significant discussions or relevant information, but not specifically listed. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Trial Management Communications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Trial Management Communications
ICH 8.3.11
Required
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Communications
Content Type
General Trial Management Communications
General_Trial_Management_Documents
100.14
X10031
eTMF
C.Schmidt CareLex
Trial Management Documents or Content that is unspecified
General Trial Management Documents
General Trial Management Documents
General, Unspecified
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Documents
SubCategory
General Trial Management Documents
General_Trial_Management_Meeting_Material
GTrial Mgmt Mtg
T100.14.12
X10034
eTMF
C.Schmidt CareLex
029
General Trial Management Meeting Material including, Agenda, presentation materials and other documentation generated during any other internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Trial Management Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Trial Management Meeting Material
Required if Applicable
Other Meeting Material, Meeting Background Materials
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Meeting_Material
Content Type
General Trial Management Meeting Material
General_Trial_Management_Tracking_Document
GTrial Mgmt Track
T100.14.11
X10033
eTMF
C.Schmidt CareLex
028
General Trial Management documents developed for the purpose of tracking activities during the course of the trial.
General Trial Management Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Trial Management Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Tracking_Document
Content Type
General Trial Management Tracking Document
General_Vendor_Communications
T108.12.10
X10220
eTMF
C.Schmidt CareLex
182
General Vendor agreements, significant discussions or relevant information, but not specifically listed.. Types of correspondence may include, but not limited to: letters, memo, electronic communications and faxes.
General Vendor Communications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Vendor Communications
ICH 8.3.11
Required if Applicable
Relevant Communications, Correspondence
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Communications
Content Type
General Vendor Communications
General_Vendor_Filenote
T108.12.13
X10223
eTMF
C.Schmidt CareLex
185
To document any decision or to clarify any information relating to the General Vendor Category.
General Vendor Filenote
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Vendor Filenote
Required if Applicable
Filenote
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Filenote
Content Type
General Vendor Filenote
General_Vendor_Meeting_Material
T108.12.12
X10222
eTMF
C.Schmidt CareLex
184
General Vendor meeting agendas, presentation materials and other documentation generated during an internal or external Category-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.
General Vendor Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Vendor Meeting Material
Required if Applicable
Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Meeting_Material
Content Type
General Vendor Meeting Material
General_Vendor_Tracking_Document
T108.12.11
X10221
eTMF
C.Schmidt CareLex
183
General Vendor documents developed for the purpose of tracking activities during the course of the trial.
General Vendor Tracking Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
General Vendor Tracking Document
Optional
Tracking Document
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Tracking_Document
Content Type
General Vendor Tracking Document
General_Vendors
108.12
X10219
eTMF
C.Schmidt CareLex
Vendor documents not otherwise specified
General Vendors
General Vendors
CareLex
http://www.CareLex.org/2012/carelex.owl#General_Vendors
SubCategory
General Vendors
IP_Accountability_Record
T105.10.14
X10145
eTMF
C.Schmidt CareLex
122
To document records of the dispensing IP to/from the subject and the reconciliation of IP prior to return to the sponsor.
IP Accountability Record
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Accountability Record
ICH 5.14.4, 8.3.23, 8.4.1
Required
Accountability Documentation, Inventory Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Accountability_Record
Content Type
IP Accountability Record
IP_Documentation
105.10
X10140
eTMF
C.Schmidt CareLex
Documents related to the recording of shipping, handling, labeling of Investigational Product (IP) and supplies
IP Documentation
IP Documentation
IP Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Documentation
SubCategory
IP Documentation
IP_Instructions_for_Handling
T105.10.11
X10142
eTMF
C.Schmidt CareLex
119
To instruct on how the IP should be handled during transit and stored upon arrival at the distribution center, depot, and/or trial site. The content should address expectations for adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused IP to the sponsor (or their delegate) If appropriate to the trial, includes preparation of the IP leading to administration.
IP Instructions for Handling
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IP Instructions for Handling
ICH 5.13.2, 5.14.3, 8.2.14
Required
Pharmacy Manual
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Instructions_for_Handling
Content Type
IP Instructions for Handling
IP_Quality_Complaint_Form
T105.10.18
X10149
eTMF
C.Schmidt CareLex
126
To document or record a product complaint.
IP Quality Complaint Form
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Quality Complaint Form
ICH 5.14.4
Required if Applicable
Compliance and/or Drug Concentration Data Listing
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Quality_Complaint_Form
Content Type
IP Quality Complaint Form
IP_Randomization
105.12
X10157
eTMF
C.Schmidt CareLex
Documents related to the blinding and randomization of Investigational Product (IP) and supplies
IP Randomization
IP Randomization
IP Allocation Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Randomization
SubCategory
IP Randomization
IP_Randomization_Plan
T105.12.10
X10158
eTMF
C.Schmidt CareLex
133
To document the treatment allocation for each subject. Used if urgent unblinding or code break is needed, or when interim or final unblinding occurs.
IP Randomization Plan
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Randomization Plan
ICH 5.13.4
Required
Treatment Allocation Documentation, Randomization envelopes, Treatment Allocation Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#I_ Randomization_Plan
Content Type
IP Randomization Plan
IP_Re-labeling_Plan
T105.10.16
X10147
eTMF
C.Schmidt CareLex
124
To document the well described plan for the re-labeling process to occur at the depot and/or site and confirmation records that the re-labeling occurred.
IP Re-labeling Plan
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Re-labeling Plan
ICH 5.14.4
Required if Applicable
Re-labeling Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Re-labeling_Plan
Content Type
IP Re-labeling Plan
IP_Recall_Plan
T105.10.17
X10148
eTMF
C.Schmidt CareLex
125
To document the well described plan for the recall process for the IP to occur at a distribution center, depot and/or site; will include confirmation records that the recall occurred.
IP Recall Plan
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Recall Plan
ICH 5.14.4
Required if Applicable
IP Recall Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Recall_Plan
Content Type
IP Recall Plan
IP_Regulatory_Release
T105.11.11
X10154
eTMF
C.Schmidt CareLex
130
To document all regulatory IP release. Second stage of a multi-stage release process, if release process required.
IP Regulatory Release
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IP Regulatory Release
ICH 2.12, 5.14.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Regulatory_Release
Content Type
IP Regulatory Release
IP_Release_Process
105.11
X10152
eTMF
C.Schmidt CareLex
Documents related to the release of Investigational Product (IP) and supplies
IP Release Process
IP Release Process
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Release_Process
SubCategory
IP Release Process
IP_Return_Record
T105.10.19
X10150
eTMF
C.Schmidt CareLex
127
To detail inventories of returns to/from a distribution center, depot, and/or trial site. Examples include courier documentation and packing/ inventory listing.
IP Return Record
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Return Record
ICH 5.14.4, 8.2.15, 8.3.9
Required
IP Documentation Return
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Return_Record
Content Type
IP Return Record
IP_Sample_Label
T105.10.12
X10143
eTMF
C.Schmidt CareLex
120
A sample of each IP label type (for every pack and every language) to be used in the trial; approval status must be clear; translation certificates are to be included. All stages of label text development are included within this content type.
IP Sample Label
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IP Sample Label
ICH 5.13.1, 8.2.13
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Sample_Label
Content Type
IP Sample Label
IP_Shipment_Record
T105.10.13
X10144
eTMF
C.Schmidt CareLex
121
To document records of the dispensing IP to/from the subject and the reconciliation of IP prior to return to the sponsor
IP Shipment Record
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Shipment Record
ICH 5.14.4, 8.2.15, 8.3.8
Required
IP Documentation of Shipment
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Shipment_Record
Content Type
IP Shipment Record
IP_Site_Release_Documentation
T104.11.26
X10101
eTMF
C.Schmidt CareLex
100
To document approval for sites to receive drug supply / investigational medicinal product.
IP Site Release Documentation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Site Release Documentation
ICH 5.14.2
Optional
Drug Release Document, Authorization to Ship Clinical Trial Materials
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Site_Release_Documentation
Content Type
IP Site Release Documentation
IP_Supply_Plan
T105.10.10
X10141
eTMF
C.Schmidt CareLex
118
To document, minimally, written procedures which define the following as they pertain to the IP: 1) quantity of active, placebo, and/or if applicable, comparator or rescue supplies needed to fulfill the requirements of the trial protocol over the life of the trial, and 2) acceptable storage temperatures and conditions, storage times, reconstitution fluids and procedures, and devices for product infusion.
IP Supply Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IP Supply Plan
ICH 2.13, 5.13.3
Optional
Trial Medication Plan, Clinical Trial Material Distribution Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Supply Plan
Content Type
IP Supply Plan
IP_Transfer_Record
T105.10.15
X10146
eTMF
C.Schmidt CareLex
123
To document the transfer of IP between depots and sites (within or across protocols). Examples include sponsor approval for transfer and evidence of consultation with Qualified Person (QP).
IP Transfer Record
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IP Transfer Record
ICH 5.14.4
Required if Applicable
IP Documentation of Transfer
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_Transfer_Record
Content Type
IP Transfer Record
IP_and_Trial_Supplies
105
X10139
eTMF
C.Schmidt CareLex
Documents related to the recording of shipping, storage, dispensing and destruction of Investigational Product (IP) and supplies
IP and Trial Supplies
IP and Trial Supplies
CareLex
http://www.CareLex.org/2012/carelex.owl#IP_and_Trial_Supplies
Primary Category
IP and Trial Supplies
IRB-IEC_Approval
T104.13.11
C70800
eTMF
C.Schmidt CareLex
Study Site specific document containing the determination of the Institutional Review Board (IRB) or independent ethics committee (IEC) that the clinical study with human subject participation has been reviewed and may be conducted at a particular study site within the constraints set forth by the IRB and other institutional and federal requirements.
IRB-IEC Approval
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approval
ICH 8.2.7, 8.3.3
Required
IRB/IEC Submission Approval
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approval
Content Type
IRB-IEC Approval
IRB-IEC_Approved_Advertisement_for_Subject_Recruitment
Subj Ads
T104.13.13
X10119
eTMF
C.Schmidt CareLex
IRB approved recruitment materials used to locate subjects for participation in a clinical trial; approved by the IRB/IEC to ensure recruitment measures are appropriate and not coercive. Site ID specified.
IRB-IEC Approved Advertisement for Subject Recruitment
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Advertisement for Subject Recruitment
ICH 8.2.3, 8.3.2
Required if Applicable
Advertisements for Subject Recruitment
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Advertisement_for_Subject_Recruitment
Content Type
IRB-IEC Approved Advertisement for Subject Recruitment
IRB-IEC_Approved_Informed_Consent
Inf Consent
T104.13.12
X16468
eTMF
C.Schmidt CareLex
IRB approved document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial; may include Assent for minors. Site ID specified.
IRB-IEC Approved Informed Consent
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Informed Consent
ICH 8.2.3, 8.3.2
Required
Informed Consent Template, Assent Template
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Informed_Consent
Content Type
IRB-IEC Approved Informed Consent
IRB-IEC_Approved_Other_Subject_Information
Subj Other
T104.13.18
X10124
eTMF
C.Schmidt CareLex
IRB approved forms to be provided to the subject to further assist with understanding the trial requirements or concepts; may include memory aids. Site ID specific.
IRB-IEC Approved Other Subject Information
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Other Subject Information
ICH 8.2.3, 8.3.2
Required if Applicable
Other Written Information Given to Subjects
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Other_Subject_Information
Content Type
IRB-IEC Approved Other Subject Information
IRB-IEC_Approved_Subject_Diary
Subj Diary
T104.13.14
X10120
eTMF
C.Schmidt CareLex
IRB approved document for subject data captured away from the site. Site ID specified.
IRB-IEC Approved Subject Diary
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Subject Diary
Required if Applicable
Subject Diary
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Diary
Content Type
IRB-IEC Approved Subject Diary
IRB-IEC_Approved_Subject_Information
Subj Inf Sht
T104.13.16
X10122
eTMF
C.Schmidt CareLex
IRB approved document showing the appropriate written information (content and wording) provided to the subject regarding the trial. Site ID specified.
IRB-IEC Approved Subject Information
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Subject Information
ICH 8.2.3, 8.3.2
Required
Subject Information Sheet
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC Approved Subject Information
Content Type
IRB-IEC Approved Subject Information
IRB-IEC_Approved_Subject_Participation
Subj Part Card
T104.13.17
X10123
eTMF
C.Schmidt CareLex
IRB approved document provided to the subject to carry to document trial participation. Site ID specified.
IRB-IEC Approved Subject Participation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Subject Participation
ICH 8.2.3, 8.3.2
Required if Applicable
Subject Participation Card
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Participation
Content Type
IRB-IEC Approved Subject Participation
IRB-IEC_Approved_Subject_Questionnaire
Subj Quest
T104.13.15
X10121
eTMF
C.Schmidt CareLex
IRB approved document to capture specific subject related information through a series of questions. Site ID specified.
IRB-IEC Approved Subject Questionnaire
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Approved Subject Questionnaire
Required if Applicable
Subject Questionnaire
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Questionnaire
Content Type
IRB-IEC Approved Subject Questionnaire
IRB-IEC_Composition
T104.13.19
X10125
eTMF
C.Schmidt CareLex
Study Site specific documentation that the Institutional Review Board (IRB) or independent ethics committee (IEC) consists of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial.
IRB-IEC Composition
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Composition
ICH 8.2.8
Required
IRB/IEC Composition, Reviewer Participant List, Membership List, Assurance Number, IRB Roster
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Composition
Content Type
IRB-IEC Composition
IRB-IEC_Documentation_of_Non-Voting_Status
T104.13.20
X10126
eTMF
C.Schmidt CareLex
Study Site specific documentation verifying non-voting members of the Institutional Review Board (IRB)or independent ethics committee (IEC) if the investigator or sub-investigator is on the IRB/IEC.
IRB-IEC Documentation of Non-Voting Status
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Documentation of Non-Voting Status
ICH 3.2.1
Required if Applicable
IRB/IEC Documentation of Non-Voting Status
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Documentation_of_Non-Voting_Status
Content Type
IRB-IEC Documentation of Non-Voting Status
IRB-IEC_Documents
104.13
X10118
eTMF
C.Schmidt CareLex
Study Site specific approvals by an Institutional Review Board (IRB) or independent ethics committee (IEC) or other body regarding human subjects in biomedical or behavioral research.
IRB-IEC Documents
IRB-IEC Documents
IRB/IEC Trial Approval
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Documents
SubCategory
IRB-IEC Documents
IRB-IEC_GCP_Compliance_Statement
T104.13.21
X10127
eTMF
C.Schmidt CareLex
Study Site specific documentation that the Institutional Review Board (IRB) or independent ethics committee (IEC) is performing its function according to written operating procedures and is in compliance with Good Clinical Practices (GCP) and applicable regulatory requirements.
IRB-IEC GCP Compliance Statement
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC GCP Compliance Statement
ICH 3.2.2, 3.4
Required if Applicable
IRB/IEC GCP Compliance Statement, Attestation Form
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_GCP_Compliance_Statement
Content Type
IRB-IEC GCP Compliance Statement
IRB-IEC_Notification_of_Trial_Termination
T104.14.12
X10133
eTMF
C.Schmidt CareLex
074
Document detailing the termination of a trial – whether upon completion or premature termination.
IRB-IEC Notification of Trial Termination
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Notification of Trial Termination
ICH 4.12, 5.21
Required
IRB/IEC Notification of Trial Termination, Notification of Discontinuation of Clinical Trial
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Notification_of_Trial_Termination
Content Type
IRB-IEC Notification of Trial Termination
IRB-IEC_Report
T104.14.11
X10132
eTMF
C.Schmidt CareLex
073
Reports issued to the Institutional Review Board (IRB) or independent ethics committee (IEC) by the sponsor/3rd Party and/or investigator e.g. Line Listings, Interim Reports or Annual Reports.
IRB-IEC Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Report
ICH 8.3.19
Required
IRB/IEC Report
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Report
Content Type
IRB-IEC Report
IRB-IEC_Sponsor_Communications
103.10
X10072
eTMF
C.Schmidt CareLex
General IRB-IEC communications, significant discussions or relevant information. Local IRB-IEC documents are filed under Site Management.
IRB-IEC Sponsor Communications
IRB-IEC Sponsor Communications
IRB/IEC and other Approvals
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Sponsor_Communications
SubCategory
IRB-IEC Sponsor Communications
IRB-IEC_Submission
T104.13.10
C25694
eTMF
C.Schmidt CareLex
Study Site specific document describing the trial or changes/updates to the trial submitted to an Institutional Review Board (IRB) independent ethics committee (IEC)for approval, including recruitment and education materials.
IRB-IEC Submission
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
IRB-IEC Submission
ICH 8.2.7, 8.3.3
Required
IRB/IEC Submission
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Submission
Content Type
IRB-IEC Submission
IRB-IEC_Trial_Status_Reporting
104.14
X10130
eTMF
C.Schmidt CareLex
The notification to an Institutional Review Board (IRB) or independent ethics committee (IEC) of all findings (new, important information on serious adverse events and or safety concerns) that could adversely affect the safety of subjects, impact the conduct of the trial or alter the IRB/IEC's approval/favorable opinion to continue the trial.
IRB-IEC Trial Status Reporting
IRB-IEC Trial Status Reporting
Trial Status Reporting
CareLex
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Trial_Status_Reporting
SubCategory
IRB-IEC Trial Status Reporting
IRT_User_Acceptance_Testing_Certification
T105.15.12
X10171
eTMF
C.Schmidt CareLex
143
To document the acceptability of the series of assessments of the interactive response technology (IRT) performed by key users of the system that are designed to show that the IRT has been correctly programmed and meets the requirements of the User Requirements Specification (URS). Minimally the signature page and may include validation or other documentation.
IRT User Acceptance Testing Certification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IRT User Acceptance Testing Certification
ICH 5.5.3
Required if Applicable
IRT UAT Scripts and Sign Off
CareLex
http://www.CareLex.org/2012/carelex.owl#IRT_User_Acceptance_Testing_Certification
Content Type
IRT User Acceptance Testing Certification
IRT_User_Manual
T105.15.13
X10172
eTMF
C.Schmidt CareLex
144
To provide instructions and define the operational instructions for the IRT for the user.
IRT User Manual
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IRT User Manual
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#IR_ User_Manual
Content Type
IRT User Manual
IRT_User_Notifications
T105.15.14
X10173
eTMF
C.Schmidt CareLex
145
To inform IRT Users of the following notifications of IVRS system access permissions for study management or site personnel, subject randomization number, IP request, IP shipments, etc.
IRT User Notifications
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IRT User Notifications
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#IRT_User_Notifications
Content Type
IRT User Notifications
IRT_User_Requirement_Specification
T105.15.10
X10169
eTMF
C.Schmidt CareLex
141
To document end user requirements from design and capabilities of the interactive response technology (IRT) such as Interactive Voice Randomization System (IVRS) or Interactive Web Randomization System (IWRS), included by not limited to screening, randomization, drug allocation, submitted to the vendor for analysis. May also include technical aspects of the system development.
IRT User Requirement Specification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IRT User Requirement Specification
ICH 5.5.3
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#IRT_User_Requirement_Specification
Content Type
IRT User Requirement Specification
IRT_Validation_Certification
T105.15.11
X10170
eTMF
C.Schmidt CareLex
142
To confirm the validation status of the interactive response technology (IRT).
IRT Validation Certification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
IRT Validation Certification
ICH 5.5.3
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#IRT_Validation _Certification
Content Type
IRT Validation Certification
Import-Export_License
T102.11.11
X10062
eTMF
C.Schmidt CareLex
057
A document issued by a national government authorizing the importation or exportation of certain goods into its territory.
Import-Export License
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Import-Export License
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Import-Export_License
Content Type
Import-Export License
Import-Export_License_Application
T102.11.10
X10061
eTMF
C.Schmidt CareLex
056
An application made to one or more regulatory agencies requesting a license to import or export the investigational product and clinical supplies.
Import-Export License Application
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Import-Export License Application
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Import-Export_License_Application
Content Type
Import-Export License Application
Indemnity
T104.11.22
X10097
eTMF
C.Schmidt CareLex
096
To provide legal protection in the event of an unforeseen adverse circumstance arising during the course of a clinical trial. May be in Clinical Trial Agreement
Indemnity
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Indemnity
ICH 8.2.4, 8.2.6
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Indemnity
Content Type
Indemnity
Independent_Data_Monitoring_Committee_Charter
IDMC Charter
T100.12.10
X10021
eTMF
C.Schmidt CareLex
018
To describe the purpose and modus operandi of the Independent Data Monitoring Committee (IDMC), which may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data and the critical efficacy endpoints and to recommend to the sponsor whether to continue, modify or stop a trial.
Independent Data Monitoring Committee Charter
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Independent Data Monitoring Committee Charter
ICH 5.5.2
Required if Applicable
Data Safety Monitoring Board (DSMB) Charter, Data Monitoring Committee
CareLex
http://www.CareLex.org/2012/carelex.owl#Independent_Data_Monitoring_Committee_Charter
Content Type
Independent Data Monitoring Committee Charter
Independent_Data_Monitoring_Committee_Correspondence
IDMC Corres
T100.12.12
X10023
eTMF
C.Schmidt CareLex
020
To document any agreements or significant decisions regarding trial conduct, protocol violations, adverse event reporting, to include minutes, reports, notifications, recommendations from the IDMC. Applicable to interim and final analyzes.
Independent Data Monitoring Committee Correspondence
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Independent Data Monitoring Committee Correspondence
ICH 1.25, 5.5.2
Required if Applicable
Data Safety Monitoring Board Correspondence, IDMC Data Package, Data Monitoring Committee
CareLex
http://www.CareLex.org/2012/carelex.owl#Independent_Data_Monitoring_Committee_Correspondence
Content Type
Independent Data Monitoring Committee Correspondence
Independent_Data_Monitoring_Committee_Member_List
IDMC Mbr list
T100.12.11
X10022
eTMF
C.Schmidt CareLex
019
To document the current composition of the IDMC.
Independent Data Monitoring Committee Member List
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Independent Data Monitoring Committee Member List
ICH 5.5.2
Required if Applicable
Data Safety Monitoring Board Member List, Data Monitoring Committee
CareLex
http://www.CareLex.org/2012/carelex.owl#Independent_Data_Monitoring_Committee_Member_List
Content Type
Independent Data Monitoring Committee Member List
Informed_Consent_Form
Inf Consent
T101.11.12
C16468
eTMF
C.Schmidt CareLex
040
Site-specific document form explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject. Site specific documents filed under Investigator Documents.
Informed Consent Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Informed Consent Form
ICH 8.2.3, 8.3.2
Required
Consent Form
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C16468
Content Type
Informed Consent Form
Insurance
Ins
T101.10.15
C16745
eTMF
C.Schmidt CareLex
036
To document that compensation to subject(s) for trial-related injury will be available may include policy and certificates, terms and conditions. Certificate is Required, policy is Optional
Insurance
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Insurance
ICH 8.2.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Insurance
Content Type
Insurance
Interactive_Response_Technology
105.15
X10168
eTMF
C.Schmidt CareLex
To document interactive response technology (IRT) used in a clinical trial
Interactive Response Technology
Interactive Response Technology
CareLex
http://www.CareLex.org/2012/carelex.owl#Interactive_Response_Technology
SubCategory
Interactive Response Technology
Interfacility_Standardization_Methods
T107.10.17
X10200
eTMF
C.Schmidt CareLex
167
To confirm that two or more facilities can perform the same test / procedure and obtain consistent results; includes but may not be limited to phantom data for CT or bioanalytical assay.
Interfacility Standardization Methods
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Interfacility Standardization Methods
ICH 8.2.12, 8.3.7
Required if applicable
Interlaboratory Comparison Testing, Proficiency Testing
CareLex
http://www.CareLex.org/2012/carelex.owl#Interfacility_Standardization_Methods
Content Type
Interfacility Standardization Methods
Interim_Analysis_Datasets
T110.12.14
X10264
eTMF
221
The datasets used for the interim analysis.
Interim Analysis Datasets
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Interim Analysis Datasets
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Datasets
Content Type
Interim Analysis Datasets
Interim_Analysis_Output
T110.12.15
X10265
eTMF
222
The Tables Listings and Figures produced from the interim analysis datasets; includes Statistics approval.
Interim Analysis Output
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Interim Analysis Output
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Output
Content Type
Interim Analysis Output
Interim_Analysis_Programs
T110.12.13
X10263
eTMF
220
The suite of programs designed to generate the interim analysis outputs as referenced in the SAP.
Interim Analysis Programs
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Interim Analysis Programs
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Programs
Content Type
Interim Analysis Programs
Interim_Analysis_Raw_Datasets
T110.12.12
X10262
eTMF
219
The export of raw data for interim analysis purposes.
Interim Analysis Raw Datasets
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Interim Analysis Raw Datasets
ICH 5.1, 5.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Raw_Datasets
Content Type
Interim Analysis Raw Datasets
Interim_Statistical_Reports
T110.13.10
X10272
eTMF
228
To summarize the relevant statistical aspects of the interim analysis. May be appended to the CSR.
Interim Statistical Reports
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Interim Statistical Reports
ICH 5.1, 5.5
Required if Applicable
Interim Statistical Report(s)
CareLex
http://www.CareLex.org/2012/carelex.owl#Interim_Statistical_Reports
Content Type
Interim Statistical Reports
Investigational_Medicinal_Product
102.11
X10060
eTMF
C.Schmidt CareLex
Documents pertaining to the investigational product - e.g., drug or device
Investigational Medicinal Product
Investigational Medicinal Product
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigational_Medicinal_Product
SubCategory
Investigational Medicinal Product
Investigator_Brochure
IB
T101.10.10
X10038
eTMF
C.Schmidt CareLex
031
To provide relevant and current clinical and non-clinical data on the investigational product(s) that is related to the study of the product(s) in human subjects.
Investigator Brochure
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Investigator Brochure
ICH 7.1, 8.2.1, 8.3.1
Required
IB
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigator_Brochure
Content Type
Investigator Brochure
Investigator_Confidentiality_Agreement
T104.10.11
X10080
eTMF
C.Schmidt CareLex
080
A document between the sponsor and an outside party (Investigator or Institution) that defines the terms and basic criteria to assure that the party (or parties) receiving confidential information will maintain confidentiality and will not use that information for any purpose other than that described in the Agreement. May also be present in the Clinical Trial Agreement
Investigator Confidentiality Agreement
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Investigator Confidentiality Agreement
ICH 1.16
Required
Confidentiality Agreement
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigator_Confidentiality_Agreement
Content Type
Investigator Confidentiality Agreement
Investigator_Documents
104.11
X10084
eTMF
C.Schmidt CareLex
Documents related to a specific investigator site
Investigator Documents
Investigator Documents
Site Set-up Documentation, Site Set-up Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigator_Documents
SubCategory
Investigator Documents
Investigator_Newsletter
Inv Newsltr
T100.10.22
X10014
eTMF
C.Schmidt CareLex
013
To inform investigative staff of common implementation issues and of the progress of the trial.
Investigator Newsletter
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Investigator Newsletter
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigator_Newsletter
Content Type
Investigator Newsletter
Investigator_Regulatory_Agreement
T104.11.18
X10093
eTMF
C.Schmidt CareLex
092
A regulatory statement from the investigator required by certain health authorities e.g. includes but is not limited to ‘Qualified Investigator Undertaking’ form and ‘Clinical Trial Site Information’ form required by Health Canada
Investigator Regulatory Agreement
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Investigator Regulatory Agreement
ICH 8.2.6
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigator_Regulatory_Agreement
Content Type
Investigator Regulatory Agreement
Investigators_Meeting_Material
Inv Mtg Matl
T100.13.12
X10030
eTMF
C.Schmidt CareLex
026
Agenda, presentation materials and other documentation made available for attendees of the investigator meeting(s). Includes meeting minutes or questions and answers (Q&A), attendance sheets and any pre-meeting material.
Investigators Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Investigators Meeting Material
ICH 4.1.2, 4.2.4
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Investigators_Meeting_Material
Content Type
Investigators Meeting Material
Kick-off_Meeting_Material
KO MM
T100.13.10
X10028
eTMF
C.Schmidt CareLex
024
Agenda, presentation materials and other documentation made available for attendees of the trial kick-off meeting.
Kick-off Meeting Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Kick-off Meeting Material
Required
Boot-up Meeting Material
CareLex
http://www.CareLex.org/2012/carelex.owl#Kick-off_Meeting_Material
Content Type
Kick-off Meeting Material
Lab_Manual
T107.10.14
C62612
eTMF
C.Schmidt CareLex
164
To outline the procedures to be followed in the collection, handling and shipping of samples; may not be available for local facilities.
Lab Manual
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Lab Manual
ICH 8.2.14
Optional
User Manual, Facility Manual, Facility Handbook
CareLex
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C62612
Content Type
Lab Manual
Laboratory_Certification
T107.10.10
X10195
eTMF
C.Schmidt CareLex
160
To document recognition and approval by an authorized accrediting body applying known acceptable standards, that the facility is competent to perform required test(s), and support reliability of results; if applicable.
Laboratory Certification
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Laboratory Certification
ICH 8.2.12, 8.3.7
Required if Applicable
Certification or Accreditation, Qualifications
CareLex
http://www.CareLex.org/2012/carelex.owl#Laboratory_Certification
Content Type
Laboratory Certification
Laboratory_Director_Curriculum_Vitae
Lab Dir CV
T107.10.16
X10199
eTMF
C.Schmidt CareLex
166
To verify that the Head of Facility is suitably qualified to lead and oversee the management and reporting of results; may be included with Certification / Accreditation; may be found in the Lab Manual.
Laboratory Director Curriculum Vitae
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Laboratory Director Curriculum Vitae
ICH 8.2.12, 8.3.7
Optional
Head of Facility Curriculum Vitae
CareLex
http://www.CareLex.org/2012/carelex.owl#Laboratory_Director_Curriculum _Vitae
Content Type
Laboratory Director Curriculum Vitae
Laboratory_Sample_Details
107.11
X10201
eTMF
C.Schmidt CareLex
Documents and details related to laboratory samples collected for a clinical trial, such as the collection, storage, shipping, tracking, location and retention of samples.
Laboratory Sample Details
Laboratory Sample Details
Sample Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Laboratory_Sample_Details
SubCategory
Laboratory Sample Details
Laboratory_Shipment_Records
T107.11.11
X10203
eTMF
C.Schmidt CareLex
169
To provide relevant details for samples sent in any one shipment.
Laboratory Shipment Records
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Laboratory Shipment Records
ICH 8.2.15, 8.3.8
Optional
Shipment Records, Specimen Shipment Records
CareLex
http://www.CareLex.org/2012/carelex.owl#Laboratory_Shipment_Records
Content Type
Laboratory Shipment Records
License
PI Lic
T104.11.15
X10090
eTMF
C.Schmidt CareLex
To document medical or other licenses for site personnel such as Principal Investigator conducting clinical trials.
License
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
License
ICH 8.2.10
Required if Applicable
Principal Investigator License
CareLex
http://www.CareLex.org/2012/carelex.owl#License
Content Type
License
Life_Sciences
X00001
C.Schmidt CareLex
Organizations in the fields of biotechnology, pharmaceuticals, biomedical technologies, life systems technologies, nutraceuticals, cosmeceuticals, food processing, environmental, biomedical devices, and organizations and institutions that devote the majority of their efforts in the various stages of research, development, technology transfer and commercialization; includes all sciences having to do with organisms such as plants, animals and human beings.
http://www.CareLex.org/2012/carelex.owl#Life_Sciences
Life Sciences
List_of_SOPs_Current_During_Trial
SOPs
T100.10.13
X10005
eTMF
C.Schmidt CareLex
004
To document which standard operating procedures (SOPs) and which versions were in effect for the duration of the trial, and trial-specific procedures created for the trial. To include Sponsor and third party SOPs
List of SOPs Current During Trial
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
List of SOPs Current During Trial
ICH 5.1.1
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#List_of_SOPs_Current_During_Trial
Content Type
List of SOPs Current During Trial
Local_Laboratory_Certification_or_Accreditation
T104.11.24
X10099
eTMF
C.Schmidt CareLex
098
To document recognition and approval by an authorized accrediting body applying known acceptable standards, that the facility is competent to perform required test(s), and support reliability of results.
Local Laboratory Certification or Accreditation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Local Laboratory Certification or Accreditation
ICH 8.2.12, 8.3.7
Required
Lab Qualifications
CareLex
http://www.CareLex.org/2012/carelex.owl#Local_Laboratory_Certification_or_Accreditation
Content Type
Local Laboratory Certification or Accreditation
Local_Laboratory_Normal_Ranges
T104.11.25
X10100
eTMF
C.Schmidt CareLex
099
To define acceptable limits (where 95% of the population that a laboratory serves will fall) for comparative interpretation that allow for medical decisions to be made; may be included in Lab Manual.
Local Laboratory Normal Ranges
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Local Laboratory Normal Ranges
ICH 8.2.11, 8.3.6
Required
Reference Ranges, Lab Normals
CareLex
http://www.CareLex.org/2012/carelex.owl#Local_Laboratory_Normal_Ranges
Content Type
Local Laboratory Normal Ranges
Magnetic_Resonance_Imaging
MR
111.12
C16809
eTMF
C.Schmidt CareLex
Subject MRIs for a specific study.
Magnetic Resonance Imaging
Magnetic Resonance Imaging
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C16809
SubCategory
Magnetic Resonance Imaging
Master_Randomization_List
T110.11.12
X10256
eTMF
213
To document the single source that holds the information on the assignment of subjects to treatment or control groups. In blinded studies, this list remains blinded until its release following the final data lock.
Master Randomization List
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Master Randomization List
ICH 6.4.8, 8.2.18, 8.4.3
Required
Randomization Schedule
CareLex
http://www.CareLex.org/2012/carelex.owl#Master_Randomization_List
Content Type
Master Randomization List
Medical_Imaging
111
C16831
eTMF
Use of digital medical images and digital imaging techniques in clinical trials to enable the capture and interpretation of clinical trial data. If not captured elsewhere, original medical image formats should be retained in the eTMF. For display purposes in web-based eTMF systems, digital medical images may be converted to JPEG 2000 or JPEG standards along with relevant metadata to identify and describe the image; Medical video may be converted to MPEG 4 format.
Medical Imaging
Medical Imaging
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C16831
Primary Category
Medical Imaging
Medical_Imaging_Other
111.16
X10290
eTMF
C.Schmidt CareLex
Subject Medical Imaging for a specific study. Category for other medical imaging formats and techniques not listed in eTMF.
Medical Imaging Other
Medical Imaging Other
CareLex
http://www.CareLex.org/2012/carelex.owl#Medical_Imaging_Other
SubCategory
Medical Imaging Other
Medical_Monitoring_Plan
Med Mon Plan
T100.10.18
X10010
eTMF
C.Schmidt CareLex
009
To describe how medical surveillance of trial subjects will be assured during the trial.
Medical Monitoring Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Medical Monitoring Plan
ICH 5.16
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Medical_Monitoring_Plan
Content Type
Medical Monitoring Plan
Monitoring_Plan
T100.10.17
X10009
eTMF
C.Schmidt CareLex
008
To describe how monitoring will be implemented during the trial, including strategy for source data verification.
Monitoring Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Monitoring Plan
ICH 5.18.3
Required
Monitoring Data Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Monitoring_Plan
Content Type
Monitoring Plan
Monitoring_Visit_Report
T104.11.32
X10107
eTMF
C.Schmidt CareLex
107
To document site visits evaluating trial conduct and compliance of the site, may include follow-up letter.
Monitoring Visit Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Monitoring Visit Report
ICH 8.3.10
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Monitoring_Visit_Report
Content Type
Monitoring Visit Report
Non-IP_Documentation
105.14
X10164
eTMF
C.Schmidt CareLex
Non-IP Documentation
Non-IP Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Non-IP_Documentation
SubCategory
Non-IP Documentation
Non-IP_Documentation_of_Return__
T105.14.12
X10167
eTMF
C.Schmidt CareLex
140
To inventory the returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot, and/or site. Examples include courier documentation and packing/ inventory listing.
Non-IP Documentation of Return
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Non-IP Documentation of Return
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Non-IP_Documentation_of_Return
Content Type
Non-IP Documentation of Return
Non-IP_Documentation_of_Shipment_
T105.14.11
X10166
eTMF
C.Schmidt CareLex
139
To inventory the shipment and any returns of certain non-IP supplies needed to fulfill the trial protocol requirements to a distribution center, depot, and/or site.
Non-IP Documentation of Shipment
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Non-IP Documentation of Shipment
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Non-IP_Documentation_of_Shipment
Content Type
Non-IP Documentation of Shipment
Non-IP_Supply_Plan_
T105.14.10
X10165
eTMF
C.Schmidt CareLex
138
An agreed upon plan which defines the details and quantity of non-IP supplies needed to fulfill the trial protocol requirements over the life of the trial. This may include but is not limited to rescue medication, supplementary medication, pre-treatment, other prophylactic therapies, drug delivery supplies (IV tubing, syringes), thermometers, and respirometers.
Non-IP Supply Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Non-IP Supply Plan
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Non-IP_Supply_Plan
Content Type
Non-IP Supply Plan
Normal_Ranges
T107.10.13
C71474
eTMF
C.Schmidt CareLex
163
To define acceptable limits (where 95% of the population that a facility serves will fall) for comparative interpretation that allow for medical decisions to be made; may be included in Lab Manual.
Normal Ranges
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Normal Ranges
ICH 8.2.11, 8.3.6
Required if Applicable
Reference Ranges
CareLex
http://www.CareLex.org/2012/carelex.owl#Normal_Ranges
Content Type
Normal Ranges
Notification_of_Regulatory_Identification_Number
T102.10.12
X10058
eTMF
C.Schmidt CareLex
054
Document identifying unique Identification (ID) number used to uniquely identify the trial or the trial level in that region, assigned by a regulatory agency – i.e., EU = EudraCT Number, FDA = IND Number.
Notification of Regulatory Identification Number
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Notification of Regulatory Identification Number
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Notification_of_Regulatory_Identification_Number
Content Type
Notification of Regulatory Identification Number
Notification_of_Safety_Information
T102.12.10
X10064
eTMF
C.Schmidt CareLex
058
Notification to Regulatory Authorities of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority's approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, Serious Breaches, cover letters and/or country-specific reporting forms.
Notification of Safety Information
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Notification of Safety Information
ICH 8.3.17
Required
Notification to Regulatory Authority of Safety/Trial Information, Safety Report
CareLex
http://www.CareLex.org/2012/carelex.owl#Notification_of_Safety_Information
Content Type
Notification of Safety Information
Notification_of_Trial_Termination
T102.12.12
X10065
eTMF
C.Schmidt CareLex
060
Document detailing the termination of a trial – whether upon completion or premature termination.
Notification of Trial Termination
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Notification of Trial Termination
ICH 4.12, 5.21
Required
Notification of Discontinuation of Clinical Trial
CareLex
http://www.CareLex.org/2012/carelex.owl#Notification_of_Trial_Termination
Content Type
Notification of Trial Termination
Notification_to_IRB-IEC_of_Safety_Information
T104.14.10
X10131
eTMF
C.Schmidt CareLex
072
To assure the Institutional Review Board (IRB) or independent ethics committee (IEC) are promptly notified of all findings (new, important information on serious adverse events and or safety concerns) that could adversely affect the safety of subjects, impact the conduct of the trial or alter the IRB/IEC's approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, SUSARs, CIOMS, MedWatch, Analysis of Similar Events, cover letters and/or IRB/IEC-specific reporting forms.
Notification to IRB-IEC of Safety Information
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Notification to IRB-IEC of Safety Information
ICH 8.3.17
Required
Safety Report, Notification to Regulatory Authority of Safety/Trial Information
CareLex
http://www.CareLex.org/2012/carelex.owl#Notification_to_IRB-IEC_of_Safety_Information
Content Type
Notification to IRB-IEC of Safety Information
Notification_to_Investigators_of_Safety_Information
T104.11.38
X10113
eTMF
C.Schmidt CareLex
113
To assure investigators are promptly notified of all findings (new, important information on serious adverse events and or safety concerns) that could adversely affect the safety of subjects, impact the conduct of the trial or alter their IRB/IEC's approval/favorable opinion to continue the trial. Notifications may include but are not limited to Quarterly line listings, SUSARs, CIOMS, MedWatch, Analysis of Similar Events, cover letters and/or country-specific reporting forms.
Notification to Investigators of Safety Information
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Notification to Investigators of Safety Information
ICH 5.16.2, 5.17, 8.3.17-18
Required if Applicable
Dear Doctor, Dear Health Care Provider Letter, Safety Letter
CareLex
http://www.CareLex.org/2012/carelex.owl#Notification_to_Investigators_of_Safety_Information
Content Type
Notification to Investigators of Safety Information
Nuclear_Medicine
NM
111.14
C16922
eTMF
C.Schmidt CareLex
Subject Nuclear Medicine for a specific study.
Nuclear Medicine
Nuclear Medicine
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C16922
SubCategory
Nuclear Medicine
Operational_Procedure_Manual
Ops Manual
T100.10.14
X10006
eTMF
C.Schmidt CareLex
005
To describe trial-related processes not covered by formal standard operating procedures. Includes manuals given to sites for ISFs
Operational Procedure Manual
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Operational Procedure Manual
ICH 5.1.1
Optional
Study Reference Manual, Work Instruction
CareLex
http://www.CareLex.org/2012/carelex.owl#Operational_Procedure_Manual
Content Type
Operational Procedure Manual
Other_Approvals
T104.13.23
X10129
eTMF
C.Schmidt CareLex
Study Site specific documentation received from the Approval Committee in response to submission indicating approval/acknowledgement of trial specifications or modifications.
Other Approvals
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Other Approvals
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Other_Approvals
Content Type
Other Approvals
Other_Financial_Agreement
T104.11.23
X10098
eTMF
C.Schmidt CareLex
097
To document agreement of trial requirements between other parties involved in the conduct of the trial. Includes indemnity unless separate document created. e.g. Pharmacy agreement, other department agreement, institutional agreement.
Other Financial Agreement
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Other Financial Agreement
ICH 8.2.4, 8.2.6
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Other_Financial_Agreement
Content Type
Other Financial Agreement
Other_Subject_Forms
Subj Other Fm
T101.11.16
X10048
eTMF
C.Schmidt CareLex
044
To be provided to the subject to further assist with understanding the trial requirements or concepts; may include memory aids. Site specific documents filed under Investigator Documents, Site Subject Documents
Other Subject Forms
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Other Subject Forms
ICH 8.2.3, 8.3.2
Required if Applicable
Other Written Information Given to Subjects
CareLex
http://www.CareLex.org/2012/carelex.owl#Other_Subject_Forms
Content Type
Other Subject Forms
Other_Submissions
T104.13.22
X10128
eTMF
C.Schmidt CareLex
Study Site specific documents describing the trial or changes/updates to the trial submitted to a committee other than the Institutional Review Board (IRB) or IEC for approval. Examples include Scientific, Institutional, Financial, Data Protection, Biobank. To include: Submissions and Correspondence
Other Submissions
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Other Submissions
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Other_Submissions
Content Type
Other Submissions
Other_non-IDMC_Trial_Committee_Document
non-IDMC Comm
T100.12.14
X10025
eTMF
C.Schmidt CareLex
022
To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event reporting from committees other than IDMC. To include charter, member list and correspondence.
Other non-IDMC Trial Committee Document
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Other non-IDMC Trial Committee Document
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Other_non-IDMC_Trial_Committee_Document
Content Type
Other non-IDMC Trial Committee Document
Pharmacokinetics_Report
PK Report
T101.12.12
X10051
eTMF
C.Schmidt CareLex
047
To present & summarize the relevant top line findings of the pharmacokinetic (PK) aspects of the interim or final analysis and may include PK analysis or reports.
Pharmacokinetics Report
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Pharmacokinetics Report
Optional
PK Report
CareLex
http://www.CareLex.org/2012/carelex.owl#Pharmacokinetics_Report
Content Type
Pharmacokinetics Report
Pharmacovigilance_Database_Line_Listing
T106.10.11
X10182
eTMF
C.Schmidt CareLex
151
Listing of data used for a variety of safety evaluation of the investigational product purposes (e.g. Serious Adverse Events (SAE) case listings, database line listings, etc.).
Pharmacovigilance Database Line Listing
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Pharmacovigilance Database Line Listing
ICH 5.16.1, 5.17.3, 8.3.17
Optional
Periodic Line Listing
CareLex
http://www.CareLex.org/2012/carelex.owl#Pharmacovigilance_Database_Line_Listing
Content Type
Pharmacovigilance Database Line Listing
Pre_Trial_Monitoring_Report
PSVR
T104.10.13
X10082
eTMF
C.Schmidt CareLex
082
To document onsite visit to determine qualification of site to participate in the trial.
Pre Trial Monitoring Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Pre Trial Monitoring Report
ICH 8.2.19
Required
Pre-Study Visit Report, Site Evaluation Visit Report
CareLex
http://www.CareLex.org/2012/carelex.owl#Pre_Trial_Monitoring_Report
Content Type
Pre Trial Monitoring Report
Pregnancy_Report
T106.11.12
X10186
eTMF
C.Schmidt CareLex
154
To organize critical data around a pregnancy that occurred whilst either the male or the female subject was participating in a clinical trial. Reporting forms and supporting data collected for pregnancy cases and their outcome. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, case unblinding form, narratives, and/or safety database case printouts.
Pregnancy Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Task
Pregnancy Report
ICH 4.11, 8.3.16
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Pregnancy_Report
Content Type
Pregnancy Report
Principal_Investigator_Curriculum_Vitae
PI CV
T104.11.13
X10088
eTMF
C.Schmidt CareLex
087
To document qualifications and eligibility of the Principal Investigator to conduct trial and/or provide medical supervision of subjects. To include updates.
Principal Investigator Curriculum Vitae
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Principal Investigator Curriculum Vitae
ICH 8.2.10, 8.3.5
Required
Investigator CVs
CareLex
http://www.CareLex.org/2012/carelex.owl#Principal_ Investigator_Curriculum_Vitae
Content Type
Principal Investigator Curriculum Vitae
Protocol
T101.10.11
C25320
eTMF
C.Schmidt CareLex
032
A formal document that describes a complete plan of research activity in the framework of a clinical study: objective(s), design, methodology, statistical considerations, and organization of a trial.
Protocol
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Protocol
ICH 1.4.4, 8.2.2
Required
Clinical Study Protocol, Protocol, Study Protocol, Full Protocol, Protocol Amendment
CareLex
http://www.CareLex.org/2012/carelex.owl#Protocol
Content Type
Protocol
Protocol_Amendment
Prot Amend
T101.10.13
X10040
eTMF
C.Schmidt CareLex
034
To describe description of change(s) to or formal clarification of a protocol. Includes justification for a non-substantial amendment, such as administrative changes.
Protocol Amendment
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Protocol Amendment
ICH 1.4.5, 8.3.2
Required if Applicable
Summary of Changes
CareLex
http://www.CareLex.org/2012/carelex.owl#Protocol_Amendment
Content Type
Protocol Amendment
Protocol_Amendment_Signature_Page
T104.11.12
X10087
eTMF
C.Schmidt CareLex
086
To document investigator and sponsor agreement to the protocol amendment.
Protocol Amendment Signature Page
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Protocol Amendment Signature Page
ICH 8.2.2
Required if Applicable
Signature Page
CareLex
http://www.CareLex.org/2012/carelex.owl#Protocol_Amendment_Signature_Page
Content Type
Protocol Amendment Signature Page
Protocol_Deviations
T104.11.35
X10110
eTMF
C.Schmidt CareLex
110
To document non-compliance/ deviations to the protocol.
Protocol Deviations
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Protocol Deviations
ICH 3.3.8, 5.18.4
Required if Applicable
Protocol Deviation Report, Deviation Log, Protocol Violation
CareLex
http://www.CareLex.org/2012/carelex.owl#Protocol_Deviations
Content Type
Protocol Deviations
Protocol_Signature_Page
T104.11.11
X10086
eTMF
C.Schmidt CareLex
085
To document investigator and sponsor agreement to the protocol.
Protocol Signature Page
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Protocol Signature Page
ICH 8.2.2
Required
Signature Page
CareLex
http://www.CareLex.org/2012/carelex.owl#Protocol_Signature_Page
Content Type
Protocol Signature Page
Protocol_Synopsis
Prot Syn
T101.10.12
X10039
eTMF
C.Schmidt CareLex
033
A summary of the pertinent points of the protocol. A local language version may be translated from Required (English) or produced in the country if required by local Regulatory Authorities or IRB/IEC
Protocol Synopsis
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Protocol Synopsis
Required if Applicable
Protocol Summary, Protocol Profile, Synopsis
CareLex
http://www.CareLex.org/2012/carelex.owl#Protocol_Synopsis
Content Type
Protocol Synopsis
Publication_Policy
Pubs Policy
T100.10.19
X10011
eTMF
C.Schmidt CareLex
010
To describe how trial results will be published if publication policy is not captured within the protocol.
Publication Policy
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Publication Policy
ICH 6.15
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Publication_Policy
Content Type
Publication Policy
Qualified_Person_Certification
T105.11.10
X10153
eTMF
C.Schmidt CareLex
129
To confirm that any IP from another country has been manufactured and checked in accordance with standards of Good Manufacturing Practices (GMP) at least equivalent to those laid down in Directive 91/356/EEC. Documents the technical release documentation including GMP certification. First stage of a multi-stage release process, if release process required.
Qualified Person Certification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Qualified Person Certification
ICH 2.12, 5.13.1
Required if Applicable
QP (Qualified Person) Certification, QP Certification
CareLex
http://www.CareLex.org/2012/carelex.owl#Qualified_Person_Certification
Content Type
Qualified Person Certification
Quality_Plan
QA Plan
T100.10.12
X10004
eTMF
C.Schmidt CareLex
003
To outline the operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. Relevant parts may include but not be limited to a plan written by a sponsor for internal oversight of study quality management, a plan between a sponsor and a third party vendor, an audit plan, data verification steps; also includes escalation in the event of a quality issue being identified and all corrective and preventative actions determined.
Quality Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Quality Plan
ICH 5.1
Optional
Joint Vendor Oversight Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Quality_Plan
Content Type
Quality Plan
Radiography
111.11
C38101
eTMF
C.Schmidt CareLex
Radiography or X-rays used in medical imaging
Radiography
Radiography
X-ray
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C38101
SubCategory
Radiography
Randomization
110.11
C25196
eTMF
The allocation of individuals to groups by chance, especially in order to control the variables in an experiment; content related to the randomization scheme for a clinical trial.
Randomization
Randomization
CareLex
http://www.CareLex.org/2012/carelex.owl#Randomization
SubCategory
Randomization
Randomization_Plan
T110.11.10
X10254
eTMF
211
To detail the randomization scheme and how the randomization will be carried out; this plan is then used to initiate programming.
Randomization Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Randomization Plan
ICH 1.48, 5.1, 5.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Randomization_Plan
Content Type
Randomization Plan
Randomization_Procedure
T110.11.11
X10255
eTMF
212
To define the procedure which defines how subjects are randomized in a trial. This could be by IRT or a manual process.
Randomization Procedure
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Randomization Procedure
ICH 1.48, 8.2.17
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Randomization_Procedure
Content Type
Randomization Procedure
Randomization_Programming
T110.11.13
X10257
eTMF
214
Computer code and the process of writing the code to generate randomization number for treatment assignment.
Randomization Programming
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Randomization Programming
ICH 5.1, 5.5
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Randomization_Programming
Content Type
Randomization Programming
Randomization_Validation
T110.11.14
X10258
eTMF
215
To verify that the randomization program generates the randomization number and treatment assignment correctly according to the randomization schema specified for the trial.
Randomization Validation
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Randomization Validation
ICH 5.1, 5.5
Required
Randomization Sign Off
CareLex
http://www.CareLex.org/2012/carelex.owl#Randomization_Validation
Content Type
Randomization Validation
Record_of_Retained_Body_Fluids_or_Tissue_Samples
T107.11.14
X10206
eTMF
C.Schmidt CareLex
172
To document location and identification of samples being held for possible future (re)testing; to include destruction records, when and if this occurs.
Record of Retained Body Fluids or Tissue Samples
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Record of Retained Body Fluids or Tissue Samples
ICH 8.3.25
Required if Applicable
Record of Retained Body Fluids / Tissue Samples
CareLex
http://www.CareLex.org/2012/carelex.owl#Record_of_Retained_BodyFluids_or_Tissue_Samples
Content Type
Record of Retained Body Fluids or Tissue Samples
Recruitment_Plan
T100.10.15
X10007
eTMF
C.Schmidt CareLex
006
To document the planned subject enrolment/recruitment goals during the trial, including contingency plans.
Recruitment Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Recruitment Plan
ICH 5.6
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Recruitment_Plan
Content Type
Recruitment Plan
Regulatory
102
C18995
eTMF
C.Schmidt CareLex
Documents and processes pertaining to compliance with government regulations and laws
Regulatory
Regulatory
Regulatory Affairs
CareLex
http://www.CareLex.org/2012/carelex.owl#Regulatory
Primary Category
Regulatory
Regulatory_Report
T102.12.11
C97107
eTMF
C.Schmidt CareLex
059
Reports filed with Regulatory Authorities across the conduct of a trial; i.e., Periodic Report, Interim Report, Annual Report.
Regulatory Report
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Regulatory Report
Required
Report
CareLex
http://www.CareLex.org/2012/carelex.owl#Regulatory_Report
Content Type
Regulatory Report
Regulatory_Submission
T102.10.10
C70885
eTMF
C.Schmidt CareLex
052
An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness.
Regulatory Submission
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Regulatory Submission
Optional
Submission
CareLex
http://www.CareLex.org/2012/carelex.owl#Regulatory_Submission
Content Type
Regulatory Submission
Reserved_T104.11.30
T104.11.30
X10105
eTMF
C.Schmidt CareLex
106
Reserved T104.11.30
Core; Date; Organization; Organization Role; Process; Site ID; Source; Task
Reserved T104.11.30
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Reserved_T104.11.30
Content Type
Reserved T104.11.30
Reserved_T104.11.31
T104.11.31
X10106
eTMF
C.Schmidt CareLex
235
Reserved T104.11.31
Core; Date; Organization; Organization Role; Process; Site ID; Source; Task
Reserved T104.11.31
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Reserved_T104.11.31
Content Type
Reserved T104.11.31
Roles_and_Responsibilities_Matrix
T108.11.13
X10218
eTMF
C.Schmidt CareLex
181
To identify range and distribution of tasks and responsibilities; may define internal assignment and all external parties; covers GCP as well as business process; often part of the Contractual Agreement.
Roles and Responsibilities Matrix
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Roles and Responsibilities Matrix
ICH 5.2.2, 5.7
Required if Applicable
Task Ownership Matrix, Transfer of Obligations, Transfer of Regulatory Obligation, Technical Agreement
CareLex
http://www.CareLex.org/2012/carelex.owl#Roles_and_Responsibilities_Matrix
Content Type
Roles and Responsibilities Matrix
SAE_Report_
T106.11.11
X10185
eTMF
C.Schmidt CareLex
153
To organize critical data around a serious adverse event, adverse event, and/or a laboratory abnormality as identified in the protocol. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms, and/or safety database case printouts.
SAE Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
SAE Report
ICH 4.11, 8.3.16
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#SAE_Report
Content Type
SAE Report
Safety_Documentation
106.10
X10180
eTMF
C.Schmidt CareLex
Safety reporting documents for a clinical trial such as Safety Mangement plan
Safety Documentation
Safety Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Safety_Documentation
SubCategory
Safety Documentation
Safety_Management_Plan
T106.10.10
X10181
eTMF
C.Schmidt CareLex
150
To clearly define the end-to-end process for the ongoing safety evaluation for the investigational product of safety; includes data to be collected, reporting objectives, and processes for a clinical trial. Plan may include but is not limited to associated documents for quality management, safety database entry specifications and templates, and/or coding guidelines.
Safety Management Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Safety Management Plan
ICH 2.2, 5.16.1
Required
Safety Reporting Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Safety_Management_Plan
Content Type
Safety Management Plan
Safety_Reporting
106
X10179
eTMF
C.Schmidt CareLex
Documents describing safety reporting, monitoring and notification for a clinical trial.
Safety Reporting
Safety Reporting
CareLex
http://www.CareLex.org/2012/carelex.owl#Safety_Reporting
Primary Category
Safety Reporting
Sample_Export_Documentation
T107.11.13
X10205
eTMF
C.Schmidt CareLex
171
To provide the necessary documentation required per country to allow for exportation of biological samples.
Sample Export Documentation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Sample Export Documentation
ICH 8.2.15, 8.3.8
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Sample_Export_Documentation
Content Type
Sample Export Documentation
Sample_Size_Calculation
T110.10.11
X10253
eTMF
210
To document the technique, assumptions and output used to calculate the sample size; can include QC and sign off.
Sample Size Calculation
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Sample Size Calculation
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Sample_Size_Calculation
Content Type
Sample Size Calculation
Sample_Storage_Condition_Log
T107.11.12
X10204
eTMF
C.Schmidt CareLex
170
To monitor and track sample storage under the appropriate conditions.
Sample Storage Condition Log
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Sample Storage Condition Log
ICH 8.2.14
Optional
Specimen Storage Condition Log, Temperature Log
CareLex
http://www.CareLex.org/2012/carelex.owl#Sample_Storage_Condition_Log
Content Type
Sample Storage Condition Log
Serious_Adverse_Event_Reconciliation
T109.12.17
X10239
eTMF
199
To document reconciliation and resolution of discrepancies between the safety and clinical databases has been completed.
Serious Adverse Event Reconciliation
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Serious Adverse Event Reconciliation
ICH 5.1, 5.5
Required
SAE Reconciliation
CareLex
http://www.CareLex.org/2012/carelex.owl#Serious_Adverse_Event_Reconciliation
Content Type
Serious Adverse Event Reconciliation
Site_Initiation
104.12
X10114
eTMF
C.Schmidt CareLex
Documents regarding initiation of site and confirmation that requirements have been met to begin trial participation.
Site Initiation
Site Initiation
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Initiation
SubCategory
Site Initiation
Site_Management
104
X10077
eTMF
C.Schmidt CareLex
Documentation related to sites selected for the trial.
Site Management
Site Management
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Management
Primary Category
Site Management
Site_Personnel_Supporting_Information
T104.11.16
X10091
eTMF
C.Schmidt CareLex
090
To document medical qualifications of the investigators. Includes list of publications, list of previous studies, training certificates for specific examinations, ICH-GCP training, etc. when applicable.
Site Personnel Supporting Information
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Site Personnel Supporting Information
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Personnel_Supporting_Information
Content Type
Site Personnel Supporting Information
Site_Selection
104.10
X10078
eTMF
C.Schmidt CareLex
Documentation related to site selection for the trial.
Site Selection
Site Selection
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Selection
SubCategory
Site Selection
Site_Signature_Sheet
T104.11.27
X10102
eTMF
C.Schmidt CareLex
101
To document delegation by the Principal Investigator of trial specific tasks to site personnel conducting the trial.
Site Signature Sheet
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Site Signature Sheet
ICH 4.1.5, 8.3.24
Required
Delegation of Authority
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Signature_Sheet
Content Type
Site Signature Sheet
Site_Training_Documentation
T104.12.12
X10117
eTMF
C.Schmidt CareLex
104
To document completion of site training, including attendance and certification. Includes EDC training
Site Training Documentation
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Site Training Documentation
ICH 4.1.1
Required
Training completion documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Training_Documentation
Content Type
Site Training Documentation
Site_Training_Material
T104.12.11
X10116
eTMF
C.Schmidt CareLex
103
To demonstrate material used to train sites. Includes electronic data capture (EDC) training
Site Training Material
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Site Training Material
ICH 4.1.1
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Site_Training_Material
Content Type
Site Training Material
Sites_Evaluated_but_not_Selected
T104.10.14
X10083
eTMF
C.Schmidt CareLex
083
Documentation related to sites evaluated but not selected for the trial.
Sites Evaluated but not Selected
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Sites Evaluated but not Selected
Optional
Investigators not used
CareLex
http://www.CareLex.org/2012/carelex.owl#Sites_Evaluated_but_not_Selected
Content Type
Sites Evaluated but not Selected
Special_Events_of_Interest
T106.11.13
X10187
eTMF
C.Schmidt CareLex
155
To organize critical data around a special event of interest, one that is of scientific and medical concern specific to the product or program. Usually requested by or submitted to Regulatory Agencies. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms, and/or safety database case printouts.
Special Events of Interest
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Special Events of Interest
Required if Applicable
Medical Events of Interest
CareLex
http://www.CareLex.org/2012/carelex.owl#Special_Events_of_Interest
Content Type
Special Events of Interest
Specimen_Label
T107.11.10
X10202
eTMF
C.Schmidt CareLex
168
To capture critical information about the collection of a sample; may include but is not limited to subject ID, date and time of collection, etc; may be included in Lab Manual.
Specimen Label
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Specimen Label
Optional
Sample Label
CareLex
http://www.CareLex.org/2012/carelex.owl#Specimen_Label
Content Type
Specimen Label
Statistical_Analysis_Plan
T110.10.10
X10252
eTMF
209
To define, in detail, the statistical aspects of the trial design, the process of data selection for all analyzes, the data items to be analyzed and all the procedures and methods to be employed in the analysis of those data items as well as the planned presentation of those results (Tables, Listings and Figures (TLFs)). Includes interim and final.
Statistical Analysis Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Statistical Analysis Plan
ICH 6.9
Required
SAP, Statistical Analysis Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Statistical_Analysis_Plan
Content Type
Statistical Analysis Plan
Statistical_Report
T110.13.11
X10273
eTMF
229
To summarize the relevant statistical aspects of the final analysis. May be appended to the CSR.
Statistical Report
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Statistical Report
ICH 5.1, 5.6
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Statistical_Report
Content Type
Statistical Report
Statistical_Report_Records
110.13
X10271
eTMF
Documents, reports or records related to the interim or final statistical data for the clinical trial
Statistical Report Records
Statistical Report Records
CareLex
http://www.CareLex.org/2012/carelex.owl#Statistical_Report_Records
SubCategory
Statistical Report Records
Statistics
110
C17167
eTMF
A branch of applied mathematics concerned with the collection and interpretation of quantitative data and the use of probability theory to estimate population parameters; use of statistics in clinical trials to interpret clinical trial data
Statistics
Statistics
CareLex
http://www.CareLex.org/2012/carelex.owl#Statistics
Primary Category
Statistics
Statistics_Oversight
110.10
X10251
eTMF
Documents related to the management of statistical data interpretation
Statistics Oversight
Statistics Oversight
CareLex
http://www.CareLex.org/2012/carelex.owl#Statistics_Oversight
SubCategory
Statistics Oversight
Study_Registry_Documents
T102.10.13
X10059
eTMF
C.Schmidt CareLex
055
Documentation related to registration of clinical trials in public registration of clinical trials in public registries such as ClinicalTrials.gov and to submission of results periodically during the study and at study completion.
Study Registry Documents
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Study Registry Documents
Required if Applicable
Public Registration
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Registry_Documents
Content Type
Study Registry Documents
Study_Site_Personnel_Details
T104.10.10
X10079
eTMF
C.Schmidt CareLex
079
To document contact information for primary points of contact at the site (e.g. Principal Investigator, Institution Name, Trial Coordinator, Contracts, etc).
Study Site Personnel Details
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Study Site Personnel Details
Optional
Site Contact Details
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Site_Personnel_Details
Content Type
Study Site Personnel Details
Study_Subject_CT
T111.13.10
X10284
eTMF
Subject CT for a specific study.
Study Subject CT
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject CT
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_CT
Content Type
Study Subject CT
Study_Subject_CT_Report
T111.13.11
X10285
eTMF
CT report linked to CT images.
Study Subject CT Report
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject CT Report
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_CT_Report
Content Type
Study Subject CT Report
Study_Subject_MRI
T111.12.10
X10282
eTMF
Subject X-rays or radiography for a specific study.
Study Subject MRI
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject MRI
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_MRI
Content Type
Study Subject MRI
Study_Subject_MRI_Report
T111.12.11
X10283
eTMF
MRI report linked to MRI images.
Study Subject MRI Report
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject MRI Report
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_MRI_Report
Content Type
Study Subject MRI Report
Study_Subject_Medical_Imaging
T111.16.10
X10291
eTMF
Subject Medical Imaging for a specific study.
Study Subject Medical Imaging
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Medical Imaging
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Medical_Imaging
Content Type
Study Subject Medical Imaging
Study_Subject_Medical_Imaging_Report
T111.16.11
X10292
eTMF
Subject Medical Imaging linked to Medical images.
Study Subject Medical Imaging Report
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Medical Imaging Report
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Medical_Imaging_Report
Content Type
Study Subject Medical Imaging Report
Study_Subject_Nuclear_Medicine
T111.14.10
X10286
eTMF
Subject Nuclear Medicine for a specific study.
Study Subject Nuclear Medicine
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Nuclear Medicine
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Nuclear_Medicine
Content Type
Study Subject Nuclear Medicine
Study_Subject_Nuclear_Medicine_Report
T111.14.11
X10287
eTMF
Nuclear Medicine report linked to Nuclear Medicine images.
Study Subject Nuclear Medicine Report
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Nuclear Medicine Report
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Nuclear_Medicine_Report
Content Type
Study Subject Nuclear Medicine Report
Study_Subject_Photos
T111.10.10
X10279
eTMF
C.Schmidt CareLex
Subject digital photographs for a specific study.
Study Subject Photos
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Photos
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Photos
Content Type
Study Subject Photos
Study_Subject_Radiography
T111.11.10
X10280
eTMF
C.Schmidt CareLex
Subject X-rays or radiography for a specific study.
Study Subject Radiography
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Radiography
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Radiography
Content Type
Study Subject Radiography
Study_Subject_Radiography_Report
T111.11.11
X10281
eTMF
Radiography report linked to radiography images.
Study Subject Radiography Report
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Radiography Report
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Radiography_Report
Content Type
Study Subject Radiography Report
Study_Subject_Ultrasound
T111.15.10
X10288
eTMF
Subject Ultrasound for a specific study.
Study Subject Ultrasound
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Ultrasound
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Ultrasound
Content Type
Study Subject Ultrasound
Study_Subject_Ultrasound_Report
T111.15.11
X10289
eTMF
Ultrasound report linked to Ultrasound images.
Study Subject Ultrasound Report
Core; Date; Organization; Organization Role; Person Role; Process; Source; Task; Visit Number; Subject Identifier; Country; Study ID
Study Subject Ultrasound Report
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Ultrasound_Report
Content Type
Study Subject Ultrasound Report
Sub-Investigator_Curriculum_Vitae
Sub-I CV
T104.11.14
X10089
eTMF
C.Schmidt CareLex
088
To document qualifications and eligibility of any sub-Investigators to conduct trial and/or provide medical supervision of subjects. Sub-Investigators include any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). To include updates. Note that a single Content Type 'Curriculum Vitae' with Person Role information could replace both Sub Investigator CV and Principal Investigator CV Content Types.
Sub-Investigator Curriculum Vitae
Core; Date; Country; Site ID; Study ID; Organization; Organization Role; Person; Person Role; Process; Source; Task
Sub-Investigator Curriculum Vitae
ICH 8.2.10, 8.3.5
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Sub-Investigator_Curriculum_Vitae
Content Type
Sub-Investigator Curriculum Vitae
Subject_Diary_Form
Subj Diary Fm
T101.11.10
X10043
eTMF
C.Schmidt CareLex
038
To document subject data captured away from the site (blank forms / templates). Site specific documents filed under Investigator Documents, Site Subject Documents
Subject Diary Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Subject Diary Form
Required if Applicable
Subject Diary
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Diary_Form
Content Type
Subject Diary Form
Subject_Document_Forms
101.11
X10042
eTMF
C.Schmidt CareLex
General Study Document templates - patient specific for subject data collection. Site specific documents filed under Investigator Documents, Site Subject Documents
Subject Document Forms
Subject Document Forms
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Document_Forms
SubCategory
Subject Document Forms
Subject_Enrollment_Log
T104.11.28
X10103
eTMF
C.Schmidt CareLex
105
To document chronological enrolment of subjects by trial number. To anonymously list all subjects enrolled for the Sponsor.
Subject Enrollment Log
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Subject Enrollment Log
ICH 8.3.20, 8.3.22
Required
Subject Log
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Enrollment_Log
Content Type
Subject Enrollment Log
Subject_Evaluability_Criteria_and_Subject_Classification
T110.12.20
X10270
eTMF
227
To document the decisions which define the criteria applied to evaluate each subject in the trial, in order to that will unambiguously assign the subject to the populations established in the SAP.
Subject Evaluability Criteria and Subject Classification
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Subject Evaluability Criteria and Subject Classification
ICH 5.1, 5.5, 6.9.7
Required
Subject Evaluability Criteria and Subject Classification, Population Definition Criteria, Protocol Violations, Deviations and Exemptions, Protocol Deviation Listing
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Evaluability_Criteria_and_Subject_Classification
Content Type
Subject Evaluability Criteria and Subject Classification
Subject_Information_Form
Subj Inf Fm
T101.11.13
X10045
eTMF
C.Schmidt CareLex
041
Form or template with the appropriate written information (content and wording) provided to the subject regarding the trial. Site specific documents filed under Investigator Documents.
Subject Information Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Subject Information Form
ICH 8.2.3, 8.3.2
Required
Subject Information Sheet
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Information_Form
Content Type
Subject Information Form
Subject_Participation_Form
Subj Part
T101.11.14
X10046
eTMF
C.Schmidt CareLex
042
To be provided to the subject to carry to document trial participation (blank template). Site specific documents filed under Investigator Documents, Site Subject Documents
Subject Participation Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Subject Participation Form
ICH 8.2.3, 8.3.2
Required if Applicable
Subject Participation Card
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Participation_Form
Content Type
Subject Participation Form
Subject_Questionnaire_Form
Subj Quest Fm
T101.11.11
X10044
eTMF
C.Schmidt CareLex
039
To capture specific subject related information through a series of questions (blank forms / templates). Site specific documents filed under Investigator Documents, Site Subject Documents
Subject Questionnaire Form
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Subject Questionnaire Form
Required if Applicable
Subject Questionnaire
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Questionnaire_Form
Content Type
Subject Questionnaire Form
Subject_Screen_Log
T104.11.29
X10104
eTMF
C.Schmidt CareLex
234
To document identification of subjects who entered pre-trial screening
Subject Screen Log
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Subject Screen Log
ICH 8.3.20, 8.3.23
Required
Subject Identification Log
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Screen_Log
Content Type
Subject Screen Log
Subject_Unblinding_Event
T105.12.12
X10160
eTMF
C.Schmidt CareLex
135
To document the action of breaking the blind for an individual subject, urgently if needed, or when interim or final unblinding occurs. Treatment unblinding may be controlled by interactive response technology (IRT) and or manually.
Subject Unblinding Event
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Subject Unblinding Event
ICH 5.13.4, 8.4.6
Required if Applicable
Treatment Decoding Documentation, Unblinding, Code Break
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Unblinding_Event
Content Type
Subject Unblinding Event
Subject_Unblinding_Plan
T105.12.11
X10159
eTMF
C.Schmidt CareLex
134
To document the plan and procedures to be taken should the action of breaking the blind for an individual subject be urgently needed, or when interim or final unblinding occurs.
Subject Unblinding Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Subject Unblinding Plan
ICH 5.13.4, 8.2.17, 8.4.3
Required
Unblinding Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Subject_Unblinding_Plan
Content Type
Subject Unblinding Plan
Supply_Import_Documentation
T107.10.15
X10198
eTMF
C.Schmidt CareLex
165
To provide the necessary documentation required per country to allow for importation of supplies or non-drug IP.
Supply Import Documentation
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Supply Import Documentation
ICH 8.2.15, 8.3.8
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Supply_Import_Documentation
Content Type
Supply Import Documentation
TSE_Statement
T105.11.12
X10155
eTMF
C.Schmidt CareLex
131
To document the confirmation that the IP either has been manufactured of materials of non-animal origin or if it is, is it certified that all measures have been taken to minimize the risk of transmitting transmissible spongiform encephalopathy (TSE) via medicinal products. May be included in Clinical Trial Applications.
TSE Statement
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
TSE Statement
ICH 8.2.15, 8.3.8
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#TSE_Statement
Content Type
TSE Statement
Template_Advertisement_for_Subject_Recruitment
Templt Subj Ads
T101.11.15
X10047
eTMF
C.Schmidt CareLex
043
To document recruitment materials used to locate subjects for participation in a clinical trial; approved by the IRB/IEC to ensure recruitment measures are appropriate and not coercive. Site specific documents filed under Investigator Documents, Site Subject Documents
Template Advertisement for Subject Recruitment
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Template Advertisement for Subject Recruitment
ICH 8.2.3, 8.3.2
Required if Applicable
Advertisements for Subject Recruitment
CareLex
http://www.CareLex.org/2012/carelex.owl#Template_Advertisement_for_Subject_Recruitment
Content Type
Template Advertisement for Subject Recruitment
Trial_Approval
102.10
X10057
eTMF
C.Schmidt CareLex
Trial Approval
Trial Approval
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Approval
SubCategory
Trial Approval
Trial_Initiation_Monitoring_Report
T104.12.10
X10115
eTMF
C.Schmidt CareLex
102
To document visit to initiate site and confirm requirements have been met to begin trial participation, and that trial procedures were reviewed with the investigator and trial personnel at the site.
Trial Initiation Monitoring Report
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Trial Initiation Monitoring Report
ICH 8.2.20
Required
Site Initiation Visit Report
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Initiation_Monitoring_Report
Content Type
Trial Initiation Monitoring Report
Trial_Management
Trial Mgmt
100
X10000
eTMF
C.Schmidt CareLex
The act of conducting, controlling or supervising a clinical trial study
Trial Management
Trial Management
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Management
Primary Category
Trial Management
Trial_Management_Meeting_Documents
100.13
X10027
eTMF
C.Schmidt CareLex
Trial Management Meeting documents including but not limited to: Agenda, presentation materials and other documentation made available for attendees of Trial Management Meetings
Trial Management Meeting Documents
Trial Management Meeting Documents
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Management_Meeting_Documents
SubCategory
Trial Management Meeting Documents
Trial_Management_Plan
TM Plan
T100.10.11
X10003
eTMF
C.Schmidt CareLex
002
To identify overall strategy for timelines, management and conduct of the trial and typically makes reference to other Content Types.
Trial Management Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Trial Management Plan
ICH 2.2
Optional
Project Management Plan
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Management_Plan
Content Type
Trial Management Plan
Trial_Master_File_Plan
TM File Plan
T100.10.10
X10002
eTMF
C.Schmidt CareLex
001
To document how records for the trial will be managed and stored during and after the trial, including procedure and documentation for destruction. To include TMF filing structure or eTMF Content Model to be used.
Trial Master File Plan
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Trial Master File Plan
ICH 5.5.7
Optional
Records Management Plan, File plan, Filing instructions
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Master_File_Plan
Content Type
Trial Master File Plan
Trial_Oversight
100.10
X10001
eTMF
C.Schmidt CareLex
The process of monitoring or supervisory authority over biomedical research for a particular study.
Trial Oversight
Trial Oversight
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Oversight
SubCategory
Trial Oversight
Trial_Regulatory_Status_Reporting
102.12
X10063
eTMF
C.Schmidt CareLex
Notification to Regulatory Authorities of clinical trial events
Trial Regulatory Status Reporting
Trial Regulatory Status Reporting
Trial Status Reporting
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Regulatory_Status_Reporting
SubCategory
Trial Regulatory Status Reporting
Trial_Safety_Status_Reporting
106.11
X10183
eTMF
C.Schmidt CareLex
Safety status reports for a clinical trial such as SAE, Pregnancy and events of special interest
Trial Safety Status Reporting
Trial Safety Status Reporting
Trial Status Reporting
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Safety_Status_Reporting
SubCategory
Trial Safety Status Reporting
Trial_Status_Report
Trial Stat Rept
T100.10.21
X10013
eTMF
C.Schmidt CareLex
012
Routine trial status progress report generated by the sponsor or 3rd Party and distributed to trial stakeholders.
Trial Status Report
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Trial Status Report
ICH 5.18.4 (g)
Optional
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Status_Report
Content Type
Trial Status Report
Trial_Supply_Storage
105.13
X10161
eTMF
C.Schmidt CareLex
Documents related to the storage of Investigational Product (IP) and supplies
Trial Supply Storage
Trial Supply Storage
Storage
CareLex
http://www.CareLex.org/2012/carelex.owl#Tria_ Supply_Storage
SubCategory
Trial Supply Storage
Trial_Supply_Storage_Condition_Excursions
T105.13.11
X10163
eTMF
C.Schmidt CareLex
137
To record excursions for IP, Non-IP and other trial supplies from the acceptable pre-defined condition range either during transit or storage at a distribution center, depot, and/or trial site.
Trial Supply Storage Condition Excursions
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Trial Supply Storage Condition Excursions
ICH 5.14.4
Required if Applicable
Storage Condition Excursion Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Supply_Storage_Condition_Excursions
Content Type
Trial Supply Storage Condition Excursions
Trial_Supply_Storage_Conditions
T105.13.10
X10162
eTMF
C.Schmidt CareLex
136
To document the unique storage conditions of the IP, Non IP and other trial supplies at the sponsor (if sponsor is distributing), distribution center, depot, and trial site, if required by the available stability requirements of the IP.
Trial Supply Storage Conditions
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Trial Supply Storage Conditions
ICH 5.14.4
Required
Storage Condition Documentation
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Supply-Storage_Conditions
Content Type
Trial Supply Storage Conditions
Trial_Team
100.11
X10017
eTMF
C.Schmidt CareLex
A defined group of team members for a clinical trial
Trial Team
Trial Team
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Team
SubCategory
Trial Team
Trial_Team_Curriculum_Vitae
Trial Tm CV
T100.11.11
X10019
eTMF
C.Schmidt CareLex
017
To document qualifications and eligibility of Trial Team Members, including sponsor and 3rd Party. May be indication of where these are filed
Trial Team Curriculum Vitae
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Trial Team Curriculum Vitae
ICH 2.8
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Team_Curriculum_Vitae
Content Type
Trial Team Curriculum Vitae
Trial_Team_Details
Trial Tm Detl
T100.11.10
X10018
eTMF
C.Schmidt CareLex
016
To define trial roles, contact details and structure of the trial team - both Sponsor and third parties; optionally this may include full and initials-only signature of all team members.
Trial Team Details
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Trial Team Details
ICH 2.8, 5.7
Required
Trial Team Roles and Responsibilities, Members List, Team Structure, Team Roster, Trial Team Log
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Team_Details
Content Type
Trial Team Details
Trial_Team_Training_Material
Trial Tm Training
T100.13.11
X10029
eTMF
C.Schmidt CareLex
025
Trial-relevant training, including use of specialized systems, to provide evidence that trial team have appropriate qualifications and experience to conduct the trial, includes evidence of training (attendance sheets) and includes all training material.
Trial Team Training Material
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Trial Team Training Material
ICH 5.4.1
Required
CareLex
http://www.CareLex.org/2012/carelex.owl#Trial_Team_Training_Material
Content Type
Trial Team Training Material
Ultrasound
US
111.15
C64384
eTMF
C.Schmidt CareLex
Subject Ultrasound for a specific study.
Ultrasound
Ultrasound
NCI
http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C64384
SubCategory
Ultrasound
Vendor_Confidentiality_Agreement
T108.11.10
X10215
eTMF
C.Schmidt CareLex
178
To confirm by written legal agreement that key information between parties will be prevented from being inappropriately disclosed. May be included in another contractual agreement.
Vendor Confidentiality Agreement
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Vendor Confidentiality Agreement
ICH 1.16
Required if Applicable
CareLex
http://www.CareLex.org/2012/carelex.owl#Vendor_Confidentiality_Agreement
Content Type
Vendor Confidentiality Agreement
Vendor_Oversight
108.10
X10212
eTMF
C.Schmidt CareLex
Documents related to the process of monitoring or supervising work done by a Vendor
Vendor Oversight
Vendor Oversight
Third Party Oversight
CareLex
http://www.CareLex.org/2012/carelex.owl#Vendor_Oversight
SubCategory
Vendor Oversight
Vendor_Records
108.11
X10214
eTMF
C.Schmidt CareLex
Documents related to the relationship between a vendor and a clinical trial sponsor or Clinical Research Organization (CRO).
Vendor Records
Vendor Records
Third Party Set-up
CareLex
http://www.CareLex.org/2012/carelex.owl#Vendor_Records
SubCategory
Vendor Records
Vendor_Selection
T108.11.11
X10216
eTMF
C.Schmidt CareLex
179
To identify how a vendor will be chosen and the criteria to be used in the process. May include document provided as part of the process
Vendor Selection
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task
Vendor Selection
Optional
Contractor Selection, Vendor Selection Documents, Contractor Selection
CareLex
http://www.CareLex.org/2012/carelex.owl#Vendor_Selection
Content Type
Vendor Selection
Vendors
108
C68608
eTMF
C.Schmidt CareLex
A person or agency that promotes or exchanges goods or services for money; a seller.
Vendors
Vendors
Third parties
CareLex
http://www.CareLex.org/2012/carelex.owl#Vendors
Primary Category
Vendors
Visit_Log
T104.11.33
X10108
eTMF
C.Schmidt CareLex
108
To document monitoring visit dates and attendees.
Visit Log
Core; Country; Date; Organization; Organization Role; Process; Site ID; Source; Study ID; Task
Visit Log
Required
Monitor visit log
CareLex
http://www.CareLex.org/2012/carelex.owl#Visit_Log
Content Type
Visit Log
eTMF
X00002
C.Schmidt CareLex
eTMF = Electronic Trial Master File. Documents or content collected, classified, indexed and archived for use in BioPharma clinical trials.
http://www.CareLex.org/2012/carelex.owl#eTMF
eTMF