336
322
337
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Radiography_Report
Study Subject Radiography Report
'Study Subject Radiography Report' SubClassOf 'Radiography'
http://www.CareLex.org/2016/carelex.owl#Edit_Check_Programming
Edit Check Programming
'Edit Check Programming' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_CT_Report
Study Subject CT Report
'Study Subject CT Report' SubClassOf 'Computed Tomography'
http://www.CareLex.org/2016/carelex.owl#Financial_Documentation
Financial Documentation
'Financial Documentation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Investigator_Newsletter
Investigator Newsletter
'Investigator Newsletter' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Statistics_Oversight
Statistics Oversight
'Statistics Oversight' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#IP_Transfer_Record
IP Transfer Record
'IP Transfer Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Sample_Storage_Condition_Log
Sample Storage Condition Log
'Sample Storage Condition Log' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Form_FDA_1572
Form FDA 1572
'Form FDA 1572' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Local_Laboratory_Normal_Ranges
Local Laboratory Normal Ranges
'Local Laboratory Normal Ranges' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Shipment_Record
IP Shipment Record
'IP Shipment Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Trial_Master_File_Plan
Trial Master File Plan
'Trial Master File Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Database
Database
'Database' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Protocol_Amendment
Protocol Amendment
'Protocol Amendment' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Investigator_Documents
Investigator Documents
'Investigator Documents' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Central_Trial_Final_Reports
Central Trial Final Reports
'Central Trial Final Reports' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Meeting_Material
Central Trial Meeting Material
'Central Trial Meeting Material' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Ultrasound
Ultrasound
'Ultrasound' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Monitoring_Plan
Monitoring Plan
'Monitoring Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Site_Signature_Sheet
Site Signature Sheet
'Site Signature Sheet' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Regulatory_Status_Reporting
Trial Regulatory Status Reporting
'Trial Regulatory Status Reporting' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Statistical_Report_Records
Statistical Report Records
'Statistical Report Records' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Filenote
IP and Trial Supplies Filenote
'IP and Trial Supplies Filenote' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Monitoring_Visit_Follow-up_Letter
Monitoring Visit Follow-up Letter
'Monitoring Visit Follow-up Letter' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Meeting_Material
Regulatory Meeting Material
'Regulatory Meeting Material' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Subject_Participation_Form
Subject Participation Form
'Subject Participation Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Evidence_of_Contractor_Compliance_
Evidence of Contractor Compliance
'Evidence of Contractor Compliance' SubClassOf 'Vendor Oversight'
http://www.CareLex.org/2016/carelex.owl#Trial_Safety_Status_Reporting
Trial Safety Status Reporting
'Trial Safety Status Reporting' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2016/carelex.owl#Template_Advertisement_for_Subject_Recruitment
Clinical Trial Subject Recruitment Advertisement
'Clinical Trial Subject Recruitment Advertisement' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Meeting_Material
Site Management Meeting Material
'Site Management Meeting Material' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Report_of_Prior_Investigations
Report of Prior Investigations
'Report of Prior Investigations' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#License
License
'License' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#List_of_SOPs_Current_During_Trial
SOP List
'SOP List' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#External_Data_Transfer_Specifications
External Data Transfer Specifications
'External Data Transfer Specifications' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Site_Initiation
Site Initiation
'Site Initiation' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Device_Review_Committee
Device Review Committee
'Device Review Committee' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Nuclear_Medicine
Study Subject Nuclear Medicine
'Study Subject Nuclear Medicine' SubClassOf 'Nuclear Medicine'
http://www.CareLex.org/2016/carelex.owl#Statistical_Report
Statistical Report
'Statistical Report' SubClassOf 'Statistical Report Records'
http://www.CareLex.org/2016/carelex.owl#Sample_Size_Calculation
Sample Size Calculation
'Sample Size Calculation' SubClassOf 'Statistics Oversight'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Filenote
Site Management Filenote
'Site Management Filenote' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Subject_Unblinding_Event
Subject Unblinding Event
'Subject Unblinding Event' SubClassOf 'IP Randomization'
http://www.CareLex.org/2016/carelex.owl#Annotated_Case_Report_Form
Annotated Case Report Form
'Annotated Case Report Form' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Participation
IRB-IEC Approved Subject Participation
'IRB-IEC Approved Subject Participation' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Other_non-IDMC_Trial_Committee_Document
Non-IDMC Trial Committee Documents Unspecified
'Non-IDMC Trial Committee Documents Unspecified' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Subject_Unblinding_Plan
Subject Unblinding Plan
'Subject Unblinding Plan' SubClassOf 'IP Randomization'
http://www.CareLex.org/2016/carelex.owl#Dictionary_Coding
Dictionary Coding
'Dictionary Coding' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Notification_of_Trial_Termination
IRB-IEC Notification of Trial Termination
'IRB-IEC Notification of Trial Termination' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Other_Subject_Information
IRB-IEC Approved Other Subject Information
'IRB-IEC Approved Other Subject Information' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Reporting
Safety Reporting Communications and Tracking
'Safety Reporting Communications and Tracking' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2016/carelex.owl#Analysis_QC_Documentation
Analysis QC Documentation
'Analysis QC Documentation' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Datasets
Final Analysis Datasets
'Final Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Report
IRB-IEC Report
'IRB-IEC Report' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_GCP_Compliance_Statement
IRB-IEC GCP Compliance Statement
'IRB-IEC GCP Compliance Statement' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Certification
Laboratory Certification
'Laboratory Certification' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Notification_of_Safety_Information
Notification of Safety Information
'Notification of Safety Information' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Case_Report_Form
Case Report Form
'Case Report Form' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Radiography
Radiography
'Radiography' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Financial_Disclosure_Summary
Financial Disclosure Summary
'Financial Disclosure Summary' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Shipment_Records
Laboratory Shipment Records
'Laboratory Shipment Records' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Study_Registry_Documents
Study Registry Documents
'Study Registry Documents' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory
Regulatory Documentation Communications and Tracking
'Regulatory Documentation Communications and Tracking' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Site_Personnel_Supporting_Information
Site Personnel Supporting Information
'Site Personnel Supporting Information' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Medical_Imaging
Study Subject Medical Imaging Unspecified
'Study Subject Medical Imaging Unspecified' SubClassOf 'Medical Imaging Unspecified'
http://www.CareLex.org/2016/carelex.owl#Quality_Plan
Quality Plan
'Quality Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Communications
Regulatory Communications
'Regulatory Communications' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Communication_Plan
Communication Plan
'Communication Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Insurance
Insurance
'Insurance' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Meeting_Material
Statistics Meeting Material
'Statistics Meeting Material' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Central_Trial_Documents
Central Trial Documents
'Central Trial Documents' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Tracking_Document
IRB-IEC Tracking Document
'IRB-IEC Tracking Document' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Risk_Management_Plan
Risk Management Plans
'Risk Management Plans' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Source_Data
Source Data
'Source Data' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_CT
Study Subject CT
'Study Subject CT' SubClassOf 'Computed Tomography'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Meeting_Material
Trial Management Meeting Material
'Trial Management Meeting Material' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Approval_for_Database_Activation
Approval for Database Activation
'Approval for Database Activation' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Safety_Documentation
Safety Documentation
'Safety Documentation' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Director_Curriculum_Vitae
Laboratory Director Curriculum Vitae
'Laboratory Director Curriculum Vitae' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Sub-Investigator_Curriculum_Vitae
Sub-Investigator Curriculum Vitae
'Sub-Investigator Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Data_Definitions_for_Analysis_Datasets
Data Definitions for Analysis Datasets
'Data Definitions for Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Meeting_Material
Centralized Testing Meeting Material
'Centralized Testing Meeting Material' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Tracking_Document
Vendor Tracking Document
'Vendor Tracking Document' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Source_Data_Verification
Source Data Verification
'Source Data Verification' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Computed_Tomography
Computed Tomography
'Computed Tomography' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Other_Subject_Forms
Other Subject Forms
'Other Subject Forms' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Data_Management_Oversight
Data Management Oversight
'Data Management Oversight' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Output
Interim Analysis Output
'Interim Analysis Output' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Vendor_Confidentiality_Agreement
Vendor Confidentiality Agreement
'Vendor Confidentiality Agreement' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#Pre_Trial_Monitoring_Report
Pre Trial Monitoring Report
'Pre Trial Monitoring Report' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Output
Final Analysis Output
'Final Analysis Output' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#IP_Recall_Plan
IP Recall Plan
'IP Recall Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Contractual_Agreement
Contractual Agreement
'Contractual Agreement' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#Regulatory
Regulatory Documentation
'Regulatory Documentation' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Investigational_Medicinal_Product
Investigational Medicinal Product
'Investigational Medicinal Product' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Protocol_Amendment_Signature_Page
Protocol Amendment Signature Page
'Protocol Amendment Signature Page' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Record_of_Retained_Body_Fluids_or_Tissue_Samples
Record of Retained Body Fluids or Tissue Samples
'Record of Retained Body Fluids or Tissue Samples' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#IP_Retest_and_Expiry_Document
IP Retest and Expiry Document
'IP Retest and Expiry Document' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Medical_Monitoring_Plan
Medical Monitoring Plan
'Medical Monitoring Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Nuclear_Medicine_Report
Study Subject Nuclear Medicine Report
'Study Subject Nuclear Medicine Report' SubClassOf 'Nuclear Medicine'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Advertisement_for_Subject_Recruitment
IRB-IEC Approved Advertisement for Subject Recruitment
'IRB-IEC Approved Advertisement for Subject Recruitment' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Documentation_of_Return__
Non-IP Documentation of Return
'Non-IP Documentation of Return' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Site_Selection
Site Selection
'Site Selection' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Trial_Initiation_Monitoring_Report
Trial Initiation Monitoring Report
'Trial Initiation Monitoring Report' SubClassOf 'Site Initiation'
http://www.CareLex.org/2016/carelex.owl#General_Vendors
Vendors Communications and Tracking
'Vendors Communications and Tracking' SubClassOf 'Vendors'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Manual
IRT User Manual
'IRT User Manual' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Roles_and_Responsibilities_Matrix
Vendor Roles and Responsibilities
'Vendor Roles and Responsibilities' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Raw_Datasets
Interim Analysis Raw Datasets
'Interim Analysis Raw Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Subject_Questionnaire_Form
Subject Questionnaire Form
'Subject Questionnaire Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Final_Trial_Close_Out_Monitoring_Report
Final Trial Close Out Monitoring Report
'Final Trial Close Out Monitoring Report' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Management
Trial Management
'Trial Management' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Acceptance_of_Investigator_Brochure
Acceptance of Investigator Brochure
'Acceptance of Investigator Brochure' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Instructions_for_Handling
IP Instructions for Handling
'IP Instructions for Handling' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Communications
Site Management Communications
'Site Management Communications' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Subject_Enrollment_Log
Subject Enrollment Log
'Subject Enrollment Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Bioanalytical_Validation_Methods
Bioanalytical Validation Methods
'Bioanalytical Validation Methods' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Testing
Centralized Testing Communications and Tracking
'Centralized Testing Communications and Tracking' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2016/carelex.owl#IP_Site_Release_Documentation
IP Site Release Documentation
'IP Site Release Documentation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Supply_Storage_Condition_Excursions
Trial Supply Storage Condition Excursions
'Trial Supply Storage Condition Excursions' SubClassOf 'Trial Supply Storage'
http://www.CareLex.org/2016/carelex.owl#Publication_Policy
Publication Policy
'Publication Policy' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Ultrasound_Report
Study Subject Ultrasound Report
'Study Subject Ultrasound Report' SubClassOf 'Ultrasound'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Programs
Interim Analysis Programs
'Interim Analysis Programs' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Documentation_of_Shipment_
Non-IP Documentation of Shipment
'Non-IP Documentation of Shipment' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Study_Site_Personnel_Details
Study Site Personnel Details
'Study Site Personnel Details' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Subject_Screen_Log
Subject Screen Log
'Subject Screen Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Financial_Disclosure_Form
Financial Disclosure Form
'Financial Disclosure Form' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Database_Lock_and_Unlock_Approval
Database Lock and Unlock Approval
'Database Lock and Unlock Approval' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Ultrasound
Study Subject Ultrasound
'Study Subject Ultrasound' SubClassOf 'Ultrasound'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Testing_Communications
Centralized Testing Communications
'Centralized Testing Communications' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IP_Documentation
IP Documentation
'IP Documentation' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Tracking_Document
Data Management Tracking Document
'Data Management Tracking Document' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Independent_Data_Monitoring_Committee_Correspondence
Independent Data Monitoring Committee Correspondence
'Independent Data Monitoring Committee Correspondence' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Certificate_of_Destruction
Certificate of Destruction
'Certificate of Destruction' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Documents
Trial Management Documents Communications and Tracking
'Trial Management Documents Communications and Tracking' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Other_Approvals
Other Approvals
'Other Approvals' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Subject_Identification_Log
Subject Identification Log
'Subject Identification Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Database_Quality_Plan
Database Quality Plan
'Database Quality Plan' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Electronic_Data_Capture_Final_Data
Electronic Data Capture Final Data
'Electronic Data Capture Final Data' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#Special_Events_of_Interest
Special Events of Interest
'Special Events of Interest' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Tracking_Document
Safety Tracking Document
'Safety Tracking Document' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#End_of_Trial
Trial Unblinding
'Trial Unblinding' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#Master_Randomization_List
Master Randomization List
'Master Randomization List' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Notifications
IRT User Notifications
'IRT User Notifications' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Supply_Plan_
Non-IP Supply Plan
'Non-IP Supply Plan' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Randomization
Randomization
'Randomization' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#Import-Export_License_Application
Import-Export License Application
'Import-Export License Application' SubClassOf 'Investigational Medicinal Product'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Raw_Datasets
Final Analysis Raw Datasets
'Final Analysis Raw Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Database_Change_Control
Database Change Control
'Database Change Control' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Documents
Central Trial Documents Communications and Tracking
'Central Trial Documents Communications and Tracking' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Communications
IP and Trial Supplies Communications
'IP and Trial Supplies Communications' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Recruitment_Plan
Recruitment Plan
'Recruitment Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Trial_Supply_Storage
Trial Supply Storage
'Trial Supply Storage' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Composition
IRB-IEC Composition
'IRB-IEC Composition' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Communications
Safety Communications
'Safety Communications' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Normal_Ranges
Normal Ranges
'Normal Ranges' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Filenote
Safety Filenote
'Safety Filenote' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Trial_Approval
Trial Approval
'Trial Approval' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Documentation
Non-IP Documentation
'Non-IP Documentation' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#IP_Supply_Plan
IP Supply Plan
'IP Supply Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Return_Record
IP Return Record
'IP Return Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Questionnaire
IRB-IEC Approved Subject Questionnaire
'IRB-IEC Approved Subject Questionnaire' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Interactive_Response_Technology
Interactive Response Technology
'Interactive Response Technology' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Vendor_Oversight
Vendor Oversight
'Vendor Oversight' SubClassOf 'Vendors'
http://www.CareLex.org/2016/carelex.owl#Informed_Consent_Form
Informed Consent Form
'Informed Consent Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Vendors
Vendors
'Vendors' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Investigator_Brochure
Investigator Brochure
'Investigator Brochure' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Communications
IRB-IEC Communications
'IRB-IEC Communications' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Investigators_Meeting_Material
Investigators Meeting Material
'Investigators Meeting Material' SubClassOf 'Trial Start Up'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Testing_Filenote
Centralized Testing Filenote
'Centralized Testing Filenote' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IRB/IEC_Progress_Report
IRB-IEC Progress Report
'IRB-IEC Progress Report' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Acceptance_Testing_Certification
IRT User Acceptance Testing Certification
'IRT User Acceptance Testing Certification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_MRI_Report
Study Subject MRI Report
'Study Subject MRI Report' SubClassOf 'Magnetic Resonance Imaging'
http://www.CareLex.org/2016/carelex.owl#Regulatory_Report
Regulatory Report
'Regulatory Report' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management
Data Management Communications and Tracking
'Data Management Communications and Tracking' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Statistics
Statistics
'Statistics' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Data_Management_Plan
Data Management Plan
'Data Management Plan' SubClassOf 'Data Management Oversight'
http://www.CareLex.org/2016/carelex.owl#Medical_Imaging
Medical Imaging
'Medical Imaging' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Trial_Status_Reporting
IRB-IEC Trial Status Reporting
'IRB-IEC Trial Status Reporting' SubClassOf 'IRB-IEC and Other Approvals'
http://www.CareLex.org/2016/carelex.owl#Dose_Escalation
Dose Escalation Documents
'Dose Escalation Documents' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#General_Statistics
Statistics Communication and Tracking
'Statistics Communication and Tracking' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#Interfacility_Standardization_Methods
Interfacility Standardization Methods
'Interfacility Standardization Methods' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Meeting_Material
IP and Trial Supplies Meeting Material
'IP and Trial Supplies Meeting Material' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Submission
IRB-IEC Submission
'IRB-IEC Submission' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Expedited_Safety_Report
Expedited Safety Report
'Expedited Safety Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Centralized_Testing
Centralized Testing
'Centralized Testing' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Safety_Management_Plan
Safety Management Plan
'Safety Management Plan' SubClassOf 'Safety Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Quality_Complaint_Form
IP Quality Complaint Form
'IP Quality Complaint Form' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Release_Process
IP Release Process
'IP Release Process' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Sample_Details
Laboratory Sample Details
'Laboratory Sample Details' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2016/carelex.owl#Operational_Procedure_Manual
Operational Procedure Manual
'Operational Procedure Manual' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#IRT_Validation_Certification
IRT Validation Certification
'IRT Validation Certification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Analysis
Analysis
'Analysis' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Tracking_Document
IP and Trial Supplies Tracking Document
'IP and Trial Supplies Tracking Document' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Randomization_Procedure
Randomization Procedure
'Randomization Procedure' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Filenote
Regulatory Filenote
'Regulatory Filenote' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Interim_Statistical_Reports
Interim Statistical Reports
'Interim Statistical Reports' SubClassOf 'Statistical Report Records'
http://www.CareLex.org/2016/carelex.owl#Trial_Team_Details
Trial Team Details
'Trial Team Details' SubClassOf 'Trial Team'
http://www.CareLex.org/2016/carelex.owl#Protocol_Signature_Page
Protocol Signature Page
'Protocol Signature Page' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Audit_Certificate
Audit Certificate
'Audit Certificate' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Indemnity
Indemnity
'Indemnity' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Communications
Vendor Communications
'Vendor Communications' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Tracking_Document
Statistics Tracking Document
'Statistics Tracking Document' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Notification_to_IRB-IEC_of_Safety_Information
Notification to IRB-IEC of Safety Information
'Notification to IRB-IEC of Safety Information' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Pharmacokinetics_Report
Pharmacokinetics Report
'Pharmacokinetics Report' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2016/carelex.owl#Protocol
Protocol
'Protocol' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Database_Account_Management
Database Account Management
'Database Account Management' SubClassOf 'EDC Management'
http://www.CareLex.org/2016/carelex.owl#Randomization_Programming
Randomization Programming
'Randomization Programming' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#General_IP_Documents
IP Documents Communications and Tracking
'IP Documents Communications and Tracking' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Data_Capture
Data Capture
'Data Capture' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Diary
IRB-IEC Approved Subject Diary
'IRB-IEC Approved Subject Diary' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Site_Training_Material
Site Training Material
'Site Training Material' SubClassOf 'Site Initiation'
http://www.CareLex.org/2016/carelex.owl#Trial_Oversight
Trial Operations
'Trial Operations' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Safety_Reporting
Safety Reporting
'Safety Reporting' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Nuclear_Medicine
Nuclear Medicine
'Nuclear Medicine' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Protocol_Deviations
Protocol Deviations
'Protocol Deviations' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Tracking_Document
Central Trial Tracking Document
'Central Trial Tracking Document' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IP_Sample_Label
IP Sample Label
'IP Sample Label' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Qualified_Person_Certification
Qualified Person Certification
'Qualified Person Certification' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#IP_Accountability_Record
IP Accountability Record
'IP Accountability Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Local_Laboratory_Certification_or_Accreditation
Local Laboratory Certification or Accreditation
'Local Laboratory Certification or Accreditation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Management_Plan
Trial Management Plan
'Trial Management Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Data_Entry_Guidelines
Data Entry Guidelines
'Data Entry Guidelines' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Feasibility_Documentation
Feasibility Documentation
'Feasibility Documentation' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Vendor_Selection
Vendor Selection
'Vendor Selection' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#CRF_Completion_Requirements
CRF Completion Requirements
'CRF Completion Requirements' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Filenote
Trial Filenote
'Trial Filenote' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Information
IRB-IEC Approved Subject Information
'IRB-IEC Approved Subject Information' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#eTMF
eTMF
'eTMF' SubClassOf 'Life Sciences'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Meeting_Material
Vendor Meeting Material
'Vendor Meeting Material' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Magnetic_Resonance_Imaging
Magnetic Resonance Imaging
'Magnetic Resonance Imaging' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Digital_Photographs
Digital Photographs
'Digital Photographs' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Tracking_Document
Trial Management Tracking Documents
'Trial Management Tracking Documents' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Pharmacovigilance_Database_Line_Listing
Pharmacovigilance Database Line Listing
'Pharmacovigilance Database Line Listing' SubClassOf 'Safety Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Re-labeling_Plan
IP Re-labeling Plan
'IP Re-labeling Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Documentation_of_Non-Voting_Status
IRB-IEC Documentation of Non-Voting Status
'IRB-IEC Documentation of Non-Voting Status' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Core_Trial_Documents
Core Trial Documents
'Core Trial Documents' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Statistical_Analysis_Plan
Statistical Analysis Plan
'Statistical Analysis Plan' SubClassOf 'Statistics Oversight'
http://www.CareLex.org/2016/carelex.owl#Notification_of_Regulatory_Identification_Number
Notification of Regulatory Identification Number
'Notification of Regulatory Identification Number' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approval
IRB-IEC Approval
'IRB-IEC Approval' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Randomization_Plan
IP Randomization Plan
'IP Randomization Plan' SubClassOf 'IP Randomization'
http://www.CareLex.org/2016/carelex.owl#Trial_Management_Meeting_Documents
Trial Start Up
'Trial Start Up' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Subject_Evaluability_Criteria_and_Subject_Classification
Subject Evaluability Criteria and Subject Classification
'Subject Evaluability Criteria and Subject Classification' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#TSE_Statement
TSE Statement
'TSE Statement' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Filenote
Statistics Filenote
'Statistics Filenote' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Other_Financial_Agreement
Other Financial Agreement
'Other Financial Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Clinical_Study_Report
Clinical Study Report
'Clinical Study Report' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Meeting_Material
IRB-IEC Meeting Material
'IRB-IEC Meeting Material' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Trial_Supply_Storage_Conditions
Trial Supply Storage Conditions
'Trial Supply Storage Conditions' SubClassOf 'Trial Supply Storage'
http://www.CareLex.org/2016/carelex.owl#Visit_Log
Visit Log
'Visit Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Investigator_Regulatory_Agreement
Investigator Regulatory Agreement
'Investigator Regulatory Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Randomization
IP Randomization
'IP Randomization' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Trial_Team_Curriculum_Vitae
Trial Team Member CV
'Trial Team Member CV' SubClassOf 'Trial Team'
http://www.CareLex.org/2016/carelex.owl#Subject_Document_Forms
Subject Document Forms
'Subject Document Forms' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Photos
Study Subject Digital Photos
'Study Subject Digital Photos' SubClassOf 'Digital Photographs'
http://www.CareLex.org/2016/carelex.owl#Clinical_Trial_Oversight_Committees
Clinical Trial Oversight Committees
'Clinical Trial Oversight Committees' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Subject_Diary_Form
Subject Diary
'Subject Diary' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Monitoring_Visit_Report
Monitoring Visit Report
'Monitoring Visit Report' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Data_Management
Data Management
'Data Management' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Tracking_Document
Centralized Testing Tracking Document
'Centralized Testing Tracking Document' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Import-Export_License
Import-Export License
'Import-Export License' SubClassOf 'Investigational Medicinal Product'
http://www.CareLex.org/2016/carelex.owl#Adjudication_Committee_Document
Adjudication Committee Document
'Adjudication Committee Document' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Facility_Documentation
Facility Documentation
'Facility Documentation' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Documents
IRB-IEC Documents
'IRB-IEC Documents' SubClassOf 'IRB-IEC and Other Approvals'
http://www.CareLex.org/2016/carelex.owl#Submissions_Non-IRB-IEC_Committees
Submissions Non-IRB-IEC Committees
'Submissions Non-IRB-IEC Committees' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Communications
Central Trial Communications
'Central Trial Communications' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_MRI
Study Subject MRI
'Study Subject MRI' SubClassOf 'Magnetic Resonance Imaging'
http://www.CareLex.org/2016/carelex.owl#Sample_Export_Documentation
Sample Export Documentation
'Sample Export Documentation' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Completed_Case_Report_Forms
Completed Case Report Forms
'Completed Case Report Forms' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#EDC_Management
EDC Management
'EDC Management' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Sites_Evaluated_but_not_Selected
Sites Evaluated but not Selected
'Sites Evaluated but not Selected' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Datasets
Interim Analysis Datasets
'Interim Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Data_Privacy_Agreement
Data Privacy Agreement
'Data Privacy Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Meeting_Material
Data Management Meeting Material
'Data Management Meeting Material' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Filenote
IRB-IEC Filenote
'IRB-IEC Filenote' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#SAE_Report_
SAE Report
'SAE Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Bioanalytical_Reports
Bioanalytical Reports
'Bioanalytical Reports' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Tracking_Document
Site Management Tracking Document
'Site Management Tracking Document' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Clinical_Study_Report_Synopsis
Clinical Study Report Synopsis
'Clinical Study Report Synopsis' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2016/carelex.owl#IP_and_Trial_Supplies
IP and Trial Supplies
'IP and Trial Supplies' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management
Site Management Communications and Tracking
'Site Management Communications and Tracking' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Trial_Status_Report
Trial Status Report
'Trial Status Report' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Programs
Final Analysis Programs
'Final Analysis Programs' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC
IRB-IEC and Other Approvals
'IRB-IEC and Other Approvals' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Sponsor_Communications
IRB-IEC Sponsor Communications and Tracking
'IRB-IEC Sponsor Communications and Tracking' SubClassOf 'IRB-IEC and Other Approvals'
http://www.CareLex.org/2016/carelex.owl#IP_Device_Maintenance_Log
IP Device Maintenance Log
'IP Device Maintenance Log' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Medical_Imaging_Other
Medical Imaging Unspecified
'Medical Imaging Unspecified' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Specimen_Label
Specimen Label
'Specimen Label' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Certificate_of_Analysis
Certificate of Analysis
'Certificate of Analysis' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#Database_Specification
Database Specification
'Database Specification' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Investigator_Confidentiality_Agreement
Site Related Confidentiality Agreement
'Site Related Confidentiality Agreement' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Debarment_Statement
Debarment Statement
'Debarment Statement' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Trial_Team_Training_Material
Trial Team Training Material
'Trial Team Training Material' SubClassOf 'Trial Start Up'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Filenote
Vendor Filenote
'Vendor Filenote' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Principal_Investigator_Curriculum_Vitae
Principal Investigator Curriculum Vitae
'Principal Investigator Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Randomization_Validation
Randomization Validation
'Randomization Validation' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#Site_Training_Documentation
Site Training Documentation
'Site Training Documentation' SubClassOf 'Site Initiation'
http://www.CareLex.org/2016/carelex.owl#Data_Validation_Certification
Data Validation Certification
'Data Validation Certification' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Data_Validation_Testing
Data Validation Testing
'Data Validation Testing' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Communications
Trial Management Communications
'Trial Management Communications' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Lab_Manual
Lab Manual
'Lab Manual' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Pregnancy_Report
Pregnancy Report
'Pregnancy Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Informed_Consent
IRB-IEC Approved Informed Consent
'IRB-IEC Approved Informed Consent' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Vendor_Records
Vendor Records
'Vendor Records' SubClassOf 'Vendors'
http://www.CareLex.org/2016/carelex.owl#Kick-off_Meeting_Material
Kick-off Meeting Material
'Kick-off Meeting Material' SubClassOf 'Trial Start Up'
http://www.CareLex.org/2016/carelex.owl#IP_Regulatory_Release
IP Regulatory Release
'IP Regulatory Release' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#Independent_Data_Monitoring_Committee_Charter
Independent Data Monitoring Committee Charter
'Independent Data Monitoring Committee Charter' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Investigators_Agreement_-_Device
Device Investigators Agreement
'Device Investigators Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Meeting_Material
Safety Meeting Material
'Safety Meeting Material' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Medical_Imaging_Report
Study Subject Medical Imaging Report Unspecified
'Study Subject Medical Imaging Report Unspecified' SubClassOf 'Medical Imaging Unspecified'
http://www.CareLex.org/2016/carelex.owl#Study_Team_Curriculum_Vitae
Study Team Curriculum Vitae
'Study Team Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Requirement_Specification
IRT User Requirement Specification
'IRT User Requirement Specification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Subject_Information_Form
Subject Information Form
'Subject Information Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Serious_Adverse_Event_Reconciliation
Serious Adverse Event Reconciliation
'Serious Adverse Event Reconciliation' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Other_Submissions
Other Submissions
'Other Submissions' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Approval
Approval
'Approval' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#Trial_Team
Trial Team
'Trial Team' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Clinical_Trial_Agreement
Clinical Trial Agreement
'Clinical Trial Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Vendor_Managment_Plan
Vendor Management Plan
'Vendor Management Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Filenote_Master_List
Filenote Master List
'Filenote Master List' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Supply_Import_Documentation
Lab Supply Import Documentation
'Lab Supply Import Documentation' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Independent_Data_Monitoring_Committee_Member_List
Independent Data Monitoring Committee Member List
'Independent Data Monitoring Committee Member List' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Protocol_Synopsis
Protocol Synopsis
'Protocol Synopsis' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Data_Validation_Plan
Data Validation Plan
'Data Validation Plan' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Technical_Design_Document
Technical Design Document
'Technical Design Document' SubClassOf 'EDC Management'
http://www.CareLex.org/2016/carelex.owl#Site_Management
Site Management
'Site Management' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Tracking_Document
Regulatory Tracking Document
'Regulatory Tracking Document' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Notification_of_Trial_Termination
Regulatory Notification of Trial Termination
'Regulatory Notification of Trial Termination' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Randomization_Plan
Randomization Plan
'Randomization Plan' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#Regulatory_Submission
Regulatory Submission
'Regulatory Submission' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#Additional_Monitoring_Activity
Supplementary Monitoring Activity
'Supplementary Monitoring Activity' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Filenote
Data Management Filenote
'Data Management Filenote' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Radiography
Study Subject Radiography
'Study Subject Radiography' SubClassOf 'Radiography'
http://www.CareLex.org/2016/carelex.owl#Data_Clarification_Forms
Data Clarification Forms
'Data Clarification Forms' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Filenote
Central Trial Filenote
'Central Trial Filenote' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Communications
Statistics Communications
'Statistics Communications' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Digital_Photos_Report
Study Subject Digital Photos Report
'Study Subject Digital Photos Report' SubClassOf 'Digital Photographs'
http://www.CareLex.org/2016/carelex.owl#Notification_to_Investigators_of_Safety_Information
Notification to Investigators of Safety Information
'Notification to Investigators of Safety Information' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Communications
Data Management Communications
'Data Management Communications' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2012/carelex.owl#Interactive_Response_Technology
Interactive Response Technology
'Interactive Response Technology' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#IP_Return_Record
IP Return Record
'IP Return Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Questionnaire
IRB-IEC Approved Subject Questionnaire
'IRB-IEC Approved Subject Questionnaire' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Tracking_Document
General IP and Trial Supplies Tracking Document
'General IP and Trial Supplies Tracking Document' SubClassOf 'General IP Documents'
http://www.CareLex.org/2012/carelex.owl#Vendors
Vendors
'Vendors' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Data_Management_Plan
Data Management Plan
'Data Management Plan' SubClassOf 'Data Management Oversight'
http://www.CareLex.org/2012/carelex.owl#Randomization
Randomization
'Randomization' SubClassOf 'Statistics'
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Testing_Filenote
General Centralized Testing Filenote
'General Centralized Testing Filenote' SubClassOf 'General Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Filenote
General Regulatory Filenote
'General Regulatory Filenote' SubClassOf 'General Regulatory'
http://www.CareLex.org/2012/carelex.owl#Statistics
Statistics
'Statistics' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#General_Data_Management
General Data Management
'General Data Management' SubClassOf 'Data Management'
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Meeting_Material
General IP and Trial Supplies Meeting Material
'General IP and Trial Supplies Meeting Material' SubClassOf 'General IP Documents'
http://www.CareLex.org/2012/carelex.owl#IRT_User_Acceptance_Testing_Certification
IRT User Acceptance Testing Certification
'IRT User Acceptance Testing Certification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2012/carelex.owl#Investigators_Meeting_Material
Investigators Meeting Material
'Investigators Meeting Material' SubClassOf 'Trial Management Meeting Documents'
http://www.CareLex.org/2012/carelex.owl#Life_Sciences
Life Sciences
http://www.CareLex.org/2012/carelex.owl#Informed_Consent_Form
Informed Consent Form
'Informed Consent Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#IP_Supply_Plan
IP Supply Plan
'IP Supply Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Investigator_Brochure
Investigator Brochure
'Investigator Brochure' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Data_Validation_Plan
Data Validation Plan
'Data Validation Plan' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#IP_Quality_Complaint_Form
IP Quality Complaint Form
'IP Quality Complaint Form' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Trial_Team_Details
Trial Team Details
'Trial Team Details' SubClassOf 'Trial Team'
http://www.CareLex.org/2012/carelex.owl#Vendor_Selection
Vendor Selection
'Vendor Selection' SubClassOf 'Vendor Records'
http://www.CareLex.org/2012/carelex.owl#Safety_Reporting
Safety Reporting
'Safety Reporting' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_MRI_Report
Study Subject MRI Report
'Study Subject MRI Report' SubClassOf 'Magnetic Resonance Imaging'
http://www.CareLex.org/2012/carelex.owl#Interfacility_Standardization_Methods
Interfacility Standardization Methods
'Interfacility Standardization Methods' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#General_Statistics
General Statistics
'General Statistics' SubClassOf 'Statistics'
http://www.CareLex.org/2012/carelex.owl#Medical_Imaging
Medical Imaging
'Medical Imaging' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Analysis
Analysis
'Analysis' SubClassOf 'Statistics'
http://www.CareLex.org/2012/carelex.owl#Safety_Management_Plan
Safety Management Plan
'Safety Management Plan' SubClassOf 'Safety Documentation'
http://www.CareLex.org/2012/carelex.owl#IP_Release_Process
IP Release Process
'IP Release Process' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#Operational_Procedure_Manual
Operational Procedure Manual
'Operational Procedure Manual' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Submission
IRB-IEC Submission
'IRB-IEC Submission' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#IRT_Validation_Certification
IRT Validation Certification
'IRT Validation Certification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2012/carelex.owl#Laboratory_Sample_Details
Laboratory Sample Details
'Laboratory Sample Details' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Communications
General Site Management Communications
'General Site Management Communications' SubClassOf 'General Site Management'
http://www.CareLex.org/2012/carelex.owl#Acceptance_of_Investigator_Brochure
Acceptance of Investigator Brochure
'Acceptance of Investigator Brochure' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Audit_Certificate
Audit Certificate
'Audit Certificate' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Protocol_Signature_Page
Protocol Signature Page
'Protocol Signature Page' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Pharmacokinetics_Report
Pharmacokinetics Report
'Pharmacokinetics Report' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2012/carelex.owl#Data_Entry_Guidelines
Data Entry Guidelines
'Data Entry Guidelines' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#Nuclear_Medicine
Nuclear Medicine
'Nuclear Medicine' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#Trial_Management_Meeting_Documents
Trial Management Meeting Documents
'Trial Management Meeting Documents' SubClassOf 'Trial Management'
http://www.CareLex.org/2012/carelex.owl#Data_Capture
Data Capture
'Data Capture' SubClassOf 'Data Management'
http://www.CareLex.org/2012/carelex.owl#Clinical_Study_Report
Clinical Study Report
'Clinical Study Report' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2012/carelex.owl#Other_Financial_Agreement
Other Financial Agreement
'Other Financial Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Randomization_Programming
Randomization Programming
'Randomization Programming' SubClassOf 'Randomization'
http://www.CareLex.org/2012/carelex.owl#TSE_Statement
TSE Statement
'TSE Statement' SubClassOf 'IP Release Process'
http://www.CareLex.org/2012/carelex.owl#Qualified_Person_Certification
Qualified Person Certification
'Qualified Person Certification' SubClassOf 'IP Release Process'
http://www.CareLex.org/2012/carelex.owl#Statistical_Analysis_Plan
Statistical Analysis Plan
'Statistical Analysis Plan' SubClassOf 'Statistics Oversight'
http://www.CareLex.org/2012/carelex.owl#Database_Account_Management
Database Account Management
'Database Account Management' SubClassOf 'EDC Management'
http://www.CareLex.org/2012/carelex.owl#Expedited_Safety_Report
Expedited Safety Report
'Expedited Safety Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2012/carelex.owl#Protocol
Protocol
'Protocol' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Core_Trial_Documents
Core Trial Documents
'Core Trial Documents' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Tracking_Document
General Central Trial Tracking Document
'General Central Trial Tracking Document' SubClassOf 'General Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Communications
General Vendor Communications
'General Vendor Communications' SubClassOf 'General Vendors'
http://www.CareLex.org/2012/carelex.owl#Indemnity
Indemnity
'Indemnity' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Tracking_Document
General Statistics Tracking Document
'General Statistics Tracking Document' SubClassOf 'General Statistics'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Documentation_of_Non-Voting_Status
IRB-IEC Documentation of Non-Voting Status
'IRB-IEC Documentation of Non-Voting Status' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#EDC_Management
EDC Management
'EDC Management' SubClassOf 'Data Management'
http://www.CareLex.org/2012/carelex.owl#IP_and_Trial_Supplies
IP and Trial Supplies
'IP and Trial Supplies' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Magnetic_Resonance_Imaging
Magnetic Resonance Imaging
'Magnetic Resonance Imaging' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Tracking_Document
General Trial Management Tracking Document
'General Trial Management Tracking Document' SubClassOf 'General Trial Management Documents'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Information
IRB-IEC Approved Subject Information
'IRB-IEC Approved Subject Information' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#General_Trial_Filenote
General Trial Filenote
'General Trial Filenote' SubClassOf 'General Trial Management Documents'
http://www.CareLex.org/2012/carelex.owl#IP_Accountability_Record
IP Accountability Record
'IP Accountability Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Protocol_Deviations
Protocol Deviations
'Protocol Deviations' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Regulatory_Report
Regulatory Report
'Regulatory Report' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Meeting_Material
General Vendor Meeting Material
'General Vendor Meeting Material' SubClassOf 'General Vendors'
http://www.CareLex.org/2012/carelex.owl#eTMF
eTMF
'eTMF' SubClassOf 'Life Sciences'
http://www.CareLex.org/2012/carelex.owl#Trial_Management_Plan
Trial Management Plan
'Trial Management Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Feasibility_Documentation
Feasibility Documentation
'Feasibility Documentation' SubClassOf 'Site Selection'
http://www.CareLex.org/2012/carelex.owl#Trial_Oversight
Trial Oversight
'Trial Oversight' SubClassOf 'Trial Management'
http://www.CareLex.org/2012/carelex.owl#CRF_Completion_Requirements
CRF Completion Requirements
'CRF Completion Requirements' SubClassOf 'Data Capture'
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Meeting_Material
General IRB-IEC Meeting Material
'General IRB-IEC Meeting Material' SubClassOf 'IRB-IEC Sponsor Communications'
http://www.CareLex.org/2012/carelex.owl#Trial_Supply_Storage_Conditions
Trial Supply Storage Conditions
'Trial Supply Storage Conditions' SubClassOf 'Trial Supply Storage'
http://www.CareLex.org/2012/carelex.owl#IP_Sample_Label
IP Sample Label
'IP Sample Label' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Diary
IRB-IEC Approved Subject Diary
'IRB-IEC Approved Subject Diary' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Visit_Log
Visit Log
'Visit Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Filenote
General Statistics Filenote
'General Statistics Filenote' SubClassOf 'General Statistics'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approval
IRB-IEC Approval
'IRB-IEC Approval' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Pharmacovigilance_Database_Line_Listing
Pharmacovigilance Database Line Listing
'Pharmacovigilance Database Line Listing' SubClassOf 'Safety Documentation'
http://www.CareLex.org/2012/carelex.owl#Notification_to_IRB-IEC_of_Safety_Information
Notification to IRB-IEC of Safety Information
'Notification to IRB-IEC of Safety Information' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2012/carelex.owl#IP_Randomization_Plan
IP Randomization Plan
'IP Randomization Plan' SubClassOf 'IP Randomization'
http://www.CareLex.org/2012/carelex.owl#IP_Re-labeling_Plan
IP Re-labeling Plan
'IP Re-labeling Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Notification_of_Regulatory_Identification_Number
Notification of Regulatory Identification Number
'Notification of Regulatory Identification Number' SubClassOf 'Trial Approval'
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Tracking_Document
General Vendor Tracking Document
'General Vendor Tracking Document' SubClassOf 'General Vendors'
http://www.CareLex.org/2012/carelex.owl#Laboratory_Director_Curriculum_Vitae
Laboratory Director Curriculum Vitae
'Laboratory Director Curriculum Vitae' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Communications
General IP and Trial Supplies Communications
'General IP and Trial Supplies Communications' SubClassOf 'General IP Documents'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Composition
IRB-IEC Composition
'IRB-IEC Composition' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Sub-Investigator_Curriculum_Vitae
Sub-Investigator Curriculum Vitae
'Sub-Investigator Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Protocol_Amendment_Signature_Page
Protocol Amendment Signature Page
'Protocol Amendment Signature Page' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Computed_Tomography
Computed Tomography
'Computed Tomography' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Raw_Datasets
Interim Analysis Raw Datasets
'Interim Analysis Raw Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Digital_Photographs
Digital Photographs
'Digital Photographs' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#IRT_User_Manual
IRT User Manual
'IRT User Manual' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2012/carelex.owl#IP_Recall_Plan
IP Recall Plan
'IP Recall Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Record_of_Retained_Body_Fluids_or_Tissue_Samples
Record of Retained Body Fluids or Tissue Samples
'Record of Retained Body Fluids or Tissue Samples' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Output
Interim Analysis Output
'Interim Analysis Output' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Regulatory
Regulatory
'Regulatory' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#IRT_User_Notifications
IRT User Notifications
'IRT User Notifications' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Meeting_Material
General Centralized Meeting Material
'General Centralized Meeting Material' SubClassOf 'General Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Communications
General Regulatory Communications
'General Regulatory Communications' SubClassOf 'General Regulatory'
http://www.CareLex.org/2012/carelex.owl#Vendor_Confidentiality_Agreement
Vendor Confidentiality Agreement
'Vendor Confidentiality Agreement' SubClassOf 'Vendor Records'
http://www.CareLex.org/2012/carelex.owl#Data_Management_Oversight
Data Management Oversight
'Data Management Oversight' SubClassOf 'Data Management'
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Output
Final Analysis Output
'Final Analysis Output' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Trial_Initiation_Monitoring_Report
Trial Initiation Monitoring Report
'Trial Initiation Monitoring Report' SubClassOf 'Site Initiation'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Advertisement_for_Subject_Recruitment
IRB-IEC Approved Advertisement for Subject Recruitment
'IRB-IEC Approved Advertisement for Subject Recruitment' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Contractual_Agreement
Contractual Agreement
'Contractual Agreement' SubClassOf 'Vendor Records'
http://www.CareLex.org/2012/carelex.owl#Subject_Questionnaire_Form
Subject Questionnaire Form
'Subject Questionnaire Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#Site_Personnel_Supporting_Information
Site Personnel Supporting Information
'Site Personnel Supporting Information' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#IP_Documentation
IP Documentation
'IP Documentation' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#Trial_Management
Trial Management
'Trial Management' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Local_Laboratory_Certification_or_Accreditation
Local Laboratory Certification or Accreditation
'Local Laboratory Certification or Accreditation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Site_Training_Material
Site Training Material
'Site Training Material' SubClassOf 'Site Initiation'
http://www.CareLex.org/2012/carelex.owl#Investigational_Medicinal_Product
Investigational Medicinal Product
'Investigational Medicinal Product' SubClassOf 'Regulatory'
http://www.CareLex.org/2012/carelex.owl#Non-IP_Documentation_of_Return__
Non-IP Documentation of Return
'Non-IP Documentation of Return' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Data_Definitions_for_Analysis_Datasets
Data Definitions for Analysis Datasets
'Data Definitions for Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Roles_and_Responsibilities_Matrix
Roles and Responsibilities Matrix
'Roles and Responsibilities Matrix' SubClassOf 'Vendor Records'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Ultrasound_Report
Study Subject Ultrasound Report
'Study Subject Ultrasound Report' SubClassOf 'Ultrasound'
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Datasets
Final Analysis Datasets
'Final Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Publication_Policy
Publication Policy
'Publication Policy' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Testing
General Centralized Testing
'General Centralized Testing' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#Financial_Disclosure_Form
Financial Disclosure Form
'Financial Disclosure Form' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Study_Site_Personnel_Details
Study Site Personnel Details
'Study Site Personnel Details' SubClassOf 'Site Selection'
http://www.CareLex.org/2012/carelex.owl#Non-IP_Documentation_of_Shipment_
Non-IP Documentation of Shipment
'Non-IP Documentation of Shipment' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Database_Quality_Plan
Database Quality Plan
'Database Quality Plan' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#Interim_Statistical_Reports
Interim Statistical Reports
'Interim Statistical Reports' SubClassOf 'Statistical Report Records'
http://www.CareLex.org/2012/carelex.owl#Final_Trial_Close_Out_Monitoring_Report
Final Trial Close Out Monitoring Report
'Final Trial Close Out Monitoring Report' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Certificate_of_Destruction
Certificate of Destruction
'Certificate of Destruction' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Subject_Enrollment_Log
Subject Enrollment Log
'Subject Enrollment Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Bioanalytical_Validation_Methods
Bioanalytical Validation Methods
'Bioanalytical Validation Methods' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#Sample_Size_Calculation
Sample Size Calculation
'Sample Size Calculation' SubClassOf 'Statistics Oversight'
http://www.CareLex.org/2012/carelex.owl#Randomization_Procedure
Randomization Procedure
'Randomization Procedure' SubClassOf 'Randomization'
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Documents
General Trial Management Documents
'General Trial Management Documents' SubClassOf 'Trial Management'
http://www.CareLex.org/2012/carelex.owl#Trial_Supply_Storage_Condition_Excursions
Trial Supply Storage Condition Excursions
'Trial Supply Storage Condition Excursions' SubClassOf 'Trial Supply Storage'
http://www.CareLex.org/2012/carelex.owl#Special_Events_of_Interest
Special Events of Interest
'Special Events of Interest' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2012/carelex.owl#Centralized_Testing
Centralized Testing
'Centralized Testing' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Database_Lock_and_Unlock_Approval
Database Lock and Unlock Approval
'Database Lock and Unlock Approval' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Testing_Communications
General Centralized Testing Communications
'General Centralized Testing Communications' SubClassOf 'General Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#Subject_Screen_Log
Subject Screen Log
'Subject Screen Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#IP_Site_Release_Documentation
IP Site Release Documentation
'IP Site Release Documentation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Evidence_of_Contractor_Compliance_
Evidence of Contractor Compliance
'Evidence of Contractor Compliance' SubClassOf 'Vendor Oversight'
http://www.CareLex.org/2012/carelex.owl#End_of_Trial
End of Trial
'End of Trial' SubClassOf 'Randomization'
http://www.CareLex.org/2012/carelex.owl#General_Safety_Tracking_Document
General Safety Tracking Document
'General Safety Tracking Document' SubClassOf 'General Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Trial_Status_Reporting
IRB-IEC Trial Status Reporting
'IRB-IEC Trial Status Reporting' SubClassOf 'Site Management'
http://www.CareLex.org/2012/carelex.owl#Dose_Escalation
Dose Escalation
'Dose Escalation' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2012/carelex.owl#Normal_Ranges
Normal Ranges
'Normal Ranges' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#General_Safety_Filenote
General Safety Filenote
'General Safety Filenote' SubClassOf 'General Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#Trial_Approval
Trial Approval
'Trial Approval' SubClassOf 'Regulatory'
http://www.CareLex.org/2012/carelex.owl#Other_Approvals
Other Approvals
'Other Approvals' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Independent_Data_Monitoring_Committee_Correspondence
Independent Data Monitoring Committee Correspondence
'Independent Data Monitoring Committee Correspondence' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2012/carelex.owl#Recruitment_Plan
Recruitment Plan
'Recruitment Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#General_Safety_Communications
General Safety Communications
'General Safety Communications' SubClassOf 'General Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Ultrasound
Study Subject Ultrasound
'Study Subject Ultrasound' SubClassOf 'Ultrasound'
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Documents
General Central Trial Documents
'General Central Trial Documents' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Non-IP_Documentation
Non-IP Documentation
'Non-IP Documentation' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Tracking_Document
General Data Management Tracking Document
'General Data Management Tracking Document' SubClassOf 'General Data Management'
http://www.CareLex.org/2012/carelex.owl#Import-Export_License_Application
Import-Export License Application
'Import-Export License Application' SubClassOf 'Investigational Medicinal Product'
http://www.CareLex.org/2012/carelex.owl#Master_Randomization_List
Master Randomization List
'Master Randomization List' SubClassOf 'Randomization'
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Raw_Datasets
Final Analysis Raw Datasets
'Final Analysis Raw Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Meeting_Material
General Central Trial Meeting Material
'General Central Trial Meeting Material' SubClassOf 'General Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Non-IP_Supply_Plan_
Non-IP Supply Plan
'Non-IP Supply Plan' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Vendor_Oversight
Vendor Oversight
'Vendor Oversight' SubClassOf 'Vendors'
http://www.CareLex.org/2012/carelex.owl#Electronic_Data_Capture_Final_Data
Electronic Data Capture Final Data
'Electronic Data Capture Final Data' SubClassOf 'Data Capture'
http://www.CareLex.org/2012/carelex.owl#Pre_Trial_Monitoring_Report
Pre Trial Monitoring Report
'Pre Trial Monitoring Report' SubClassOf 'Site Selection'
http://www.CareLex.org/2012/carelex.owl#Central_Trial_Final_Reports
Central Trial Final Reports
'Central Trial Final Reports' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Investigator_Newsletter
Investigator Newsletter
'Investigator Newsletter' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Local_Laboratory_Normal_Ranges
Local Laboratory Normal Ranges
'Local Laboratory Normal Ranges' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Statistics_Oversight
Statistics Oversight
'Statistics Oversight' SubClassOf 'Statistics'
http://www.CareLex.org/2012/carelex.owl#Investigator_Documents
Investigator Documents
'Investigator Documents' SubClassOf 'Site Management'
http://www.CareLex.org/2012/carelex.owl#Financial_Documentation
Financial Documentation
'Financial Documentation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Notification_of_Trial_Termination
IRB-IEC Notification of Trial Termination
'IRB-IEC Notification of Trial Termination' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2012/carelex.owl#Sample_Storage_Condition_Log
Sample Storage Condition Log
'Sample Storage Condition Log' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_CT
Study Subject CT
'Study Subject CT' SubClassOf 'Computed Tomography'
http://www.CareLex.org/2012/carelex.owl#Ultrasound
Ultrasound
'Ultrasound' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#Form_FDA_1572
Form FDA 1572
'Form FDA 1572' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#IP_Transfer_Record
IP Transfer Record
'IP Transfer Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_CT_Report
Study Subject CT Report
'Study Subject CT Report' SubClassOf 'Computed Tomography'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Radiography_Report
Study Subject Radiography Report
'Study Subject Radiography Report' SubClassOf 'Radiography'
http://www.CareLex.org/2012/carelex.owl#Subject_Unblinding_Event
Subject Unblinding Event
'Subject Unblinding Event' SubClassOf 'IP Randomization'
http://www.CareLex.org/2012/carelex.owl#Trial_Supply_Storage
Trial Supply Storage
'Trial Supply Storage' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#Other_non-IDMC_Trial_Committee_Document
Other non-IDMC Trial Committee Document
'Other non-IDMC Trial Committee Document' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2012/carelex.owl#General_IP_and_Trial_Supplies_Filenote
General IP and Trial Supplies Filenote
'General IP and Trial Supplies Filenote' SubClassOf 'General IP Documents'
http://www.CareLex.org/2012/carelex.owl#Database
Database
'Database' SubClassOf 'Data Management'
http://www.CareLex.org/2012/carelex.owl#Trial_Master_File_Plan
Trial Master File Plan
'Trial Master File Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Trial_Regulatory_Status_Reporting
Trial Regulatory Status Reporting
'Trial Regulatory Status Reporting' SubClassOf 'Regulatory'
http://www.CareLex.org/2012/carelex.owl#IP_Shipment_Record
IP Shipment Record
'IP Shipment Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Site_Initiation
Site Initiation
'Site Initiation' SubClassOf 'Site Management'
http://www.CareLex.org/2012/carelex.owl#Additional_Monitoring_Activity
Additional Monitoring Activity
'Additional Monitoring Activity' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Protocol_Amendment
Protocol Amendment
'Protocol Amendment' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Meeting_Material
General Site Management Meeting Material
'General Site Management Meeting Material' SubClassOf 'General Site Management'
http://www.CareLex.org/2012/carelex.owl#Site_Management
Site Management
'Site Management' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Trial_Safety_Status_Reporting
Trial Safety Status Reporting
'Trial Safety Status Reporting' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#External_Data_Transfer_Specifications
External Data Transfer Specifications
'External Data Transfer Specifications' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Filenote
General Site Management Filenote
'General Site Management Filenote' SubClassOf 'General Site Management'
http://www.CareLex.org/2012/carelex.owl#Statistical_Report_Records
Statistical Report Records
'Statistical Report Records' SubClassOf 'Statistics'
http://www.CareLex.org/2012/carelex.owl#Annotated_Case_Report_Form
Annotated Case Report Form
'Annotated Case Report Form' SubClassOf 'Data Capture'
http://www.CareLex.org/2012/carelex.owl#Case_Report_Form
Case Report Form
'Case Report Form' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Meeting_Material
General Regulatory Meeting Material
'General Regulatory Meeting Material' SubClassOf 'General Regulatory'
http://www.CareLex.org/2012/carelex.owl#Subject_Unblinding_Plan
Subject Unblinding Plan
'Subject Unblinding Plan' SubClassOf 'IP Randomization'
http://www.CareLex.org/2012/carelex.owl#Dictionary_Coding
Dictionary Coding
'Dictionary Coding' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Subject_Participation
IRB-IEC Approved Subject Participation
'IRB-IEC Approved Subject Participation' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Radiography
Radiography
'Radiography' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#Analysis_QC_Documentation
Analysis QC Documentation
'Analysis QC Documentation' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Programs
Interim Analysis Programs
'Interim Analysis Programs' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Nuclear_Medicine
Study Subject Nuclear Medicine
'Study Subject Nuclear Medicine' SubClassOf 'Nuclear Medicine'
http://www.CareLex.org/2012/carelex.owl#License
License
'License' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Statistical_Report
Statistical Report
'Statistical Report' SubClassOf 'Statistical Report Records'
http://www.CareLex.org/2012/carelex.owl#Notification_of_Safety_Information
Notification of Safety Information
'Notification of Safety Information' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2012/carelex.owl#Financial_Disclosure_Summary
Financial Disclosure Summary
'Financial Disclosure Summary' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Reserved_T104.11.31
Reserved T104.11.31
'Reserved T104.11.31' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Laboratory_Shipment_Records
Laboratory Shipment Records
'Laboratory Shipment Records' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2012/carelex.owl#Reserved_T104.11.30
Reserved T104.11.30
'Reserved T104.11.30' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Other_Subject_Information
IRB-IEC Approved Other Subject Information
'IRB-IEC Approved Other Subject Information' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_GCP_Compliance_Statement
IRB-IEC GCP Compliance Statement
'IRB-IEC GCP Compliance Statement' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#General_Safety_Reporting
General Safety Reporting
'General Safety Reporting' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#General_Regulatory
General Regulatory
'General Regulatory' SubClassOf 'Regulatory'
http://www.CareLex.org/2012/carelex.owl#IP_Instructions_for_Handling
IP Instructions for Handling
'IP Instructions for Handling' SubClassOf 'IP Documentation'
http://www.CareLex.org/2012/carelex.owl#Study_Registry_Documents
Study Registry Documents
'Study Registry Documents' SubClassOf 'Trial Approval'
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Tracking_Document
General IRB-IEC Tracking Document
'General IRB-IEC Tracking Document' SubClassOf 'IRB-IEC Sponsor Communications'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Report
IRB-IEC Report
'IRB-IEC Report' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2012/carelex.owl#General_Vendors
General Vendors
'General Vendors' SubClassOf 'Vendors'
http://www.CareLex.org/2012/carelex.owl#Site_Selection
Site Selection
'Site Selection' SubClassOf 'Site Management'
http://www.CareLex.org/2012/carelex.owl#Medical_Monitoring_Plan
Medical Monitoring Plan
'Medical Monitoring Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Communication_Plan
Communication Plan
'Communication Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Nuclear_Medicine_Report
Study Subject Nuclear Medicine Report
'Study Subject Nuclear Medicine Report' SubClassOf 'Nuclear Medicine'
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Meeting_Material
General Trial Management Meeting Material
'General Trial Management Meeting Material' SubClassOf 'General Trial Management Documents'
http://www.CareLex.org/2012/carelex.owl#Safety_Documentation
Safety Documentation
'Safety Documentation' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#Approval_for_Database_Activation
Approval for Database Activation
'Approval for Database Activation' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#Monitoring_Plan
Monitoring Plan
'Monitoring Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Subject_Participation_Form
Subject Participation Form
'Subject Participation Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Meeting_Material
General Statistics Meeting Material
'General Statistics Meeting Material' SubClassOf 'General Statistics'
http://www.CareLex.org/2012/carelex.owl#Laboratory_Certification
Laboratory Certification
'Laboratory Certification' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Medical_Imaging
Study Subject Medical Imaging
'Study Subject Medical Imaging' SubClassOf 'Medical Imaging Other'
http://www.CareLex.org/2012/carelex.owl#Other_Subject_Forms
Other Subject Forms
'Other Subject Forms' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#Insurance
Insurance
'Insurance' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#General_Centralized_Tracking_Document
General Centralized Tracking Document
'General Centralized Tracking Document' SubClassOf 'General Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#IP_Regulatory_Release
IP Regulatory Release
'IP Regulatory Release' SubClassOf 'IP Release Process'
http://www.CareLex.org/2012/carelex.owl#Subject_Diary_Form
Subject Diary Form
'Subject Diary Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#Subject_Document_Forms
Subject Document Forms
'Subject Document Forms' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#IP_Randomization
IP Randomization
'IP Randomization' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#Investigator_Regulatory_Agreement
Investigator Regulatory Agreement
'Investigator Regulatory Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Debarment_Statement
Debarment Statement
'Debarment Statement' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Trial_Team_Curriculum_Vitae
Trial Team Curriculum Vitae
'Trial Team Curriculum Vitae' SubClassOf 'Trial Team'
http://www.CareLex.org/2012/carelex.owl#Sites_Evaluated_but_not_Selected
Sites Evaluated but not Selected
'Sites Evaluated but not Selected' SubClassOf 'Site Selection'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Photos
Study Subject Photos
'Study Subject Photos' SubClassOf 'Digital Photographs'
http://www.CareLex.org/2012/carelex.owl#Final_Analysis_Programs
Final Analysis Programs
'Final Analysis Programs' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Quality_Plan
Quality Plan
'Quality Plan' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Data_Management
Data Management
'Data Management' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Pregnancy_Report
Pregnancy Report
'Pregnancy Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2012/carelex.owl#Subject_Evaluability_Criteria_and_Subject_Classification
Subject Evaluability Criteria and Subject Classification
'Subject Evaluability Criteria and Subject Classification' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Clinical_Trial_Oversight_Committees
Clinical Trial Oversight Committees
'Clinical Trial Oversight Committees' SubClassOf 'Trial Management'
http://www.CareLex.org/2012/carelex.owl#Principal_Investigator_Curriculum_Vitae
Principal Investigator Curriculum Vitae
'Principal Investigator Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Randomization_Validation
Randomization Validation
'Randomization Validation' SubClassOf 'Randomization'
http://www.CareLex.org/2012/carelex.owl#Facility_Documentation
Facility Documentation
'Facility Documentation' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Documents
IRB-IEC Documents
'IRB-IEC Documents' SubClassOf 'Site Management'
http://www.CareLex.org/2012/carelex.owl#Central_Trial_Documents
Central Trial Documents
'Central Trial Documents' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#Import-Export_License
Import-Export License
'Import-Export License' SubClassOf 'Investigational Medicinal Product'
http://www.CareLex.org/2012/carelex.owl#General_Regulatory_Tracking_Document
General Regulatory Tracking Document
'General Regulatory Tracking Document' SubClassOf 'General Regulatory'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Sponsor_Communications
IRB-IEC Sponsor Communications
'IRB-IEC Sponsor Communications' SubClassOf 'General IRB-IEC'
http://www.CareLex.org/2012/carelex.owl#Monitoring_Visit_Report
Monitoring Visit Report
'Monitoring Visit Report' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Filenote
General IRB-IEC Filenote
'General IRB-IEC Filenote' SubClassOf 'IRB-IEC Sponsor Communications'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_MRI
Study Subject MRI
'Study Subject MRI' SubClassOf 'Magnetic Resonance Imaging'
http://www.CareLex.org/2012/carelex.owl#Clinical_Study_Report_Synopsis
Clinical Study Report Synopsis
'Clinical Study Report Synopsis' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2012/carelex.owl#Interim_Analysis_Datasets
Interim Analysis Datasets
'Interim Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2012/carelex.owl#Site_Training_Documentation
Site Training Documentation
'Site Training Documentation' SubClassOf 'Site Initiation'
http://www.CareLex.org/2012/carelex.owl#General_Site_Management_Tracking_Document
General Site Management Tracking Document
'General Site Management Tracking Document' SubClassOf 'General Site Management'
http://www.CareLex.org/2012/carelex.owl#General_Vendor_Filenote
General Vendor Filenote
'General Vendor Filenote' SubClassOf 'General Vendors'
http://www.CareLex.org/2012/carelex.owl#Data_Privacy_Agreement
Data Privacy Agreement
'Data Privacy Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Trial_Team_Training_Material
Trial Team Training Material
'Trial Team Training Material' SubClassOf 'Trial Management Meeting Documents'
http://www.CareLex.org/2012/carelex.owl#Completed_Case_Report_Forms
Completed Case Report Forms
'Completed Case Report Forms' SubClassOf 'Data Capture'
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Meeting_Material
General Data Management Meeting Material
'General Data Management Meeting Material' SubClassOf 'General Data Management'
http://www.CareLex.org/2012/carelex.owl#IRB-IEC_Approved_Informed_Consent
IRB-IEC Approved Informed Consent
'IRB-IEC Approved Informed Consent' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Medical_Imaging_Other
Medical Imaging Other
'Medical Imaging Other' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2012/carelex.owl#Trial_Status_Report
Trial Status Report
'Trial Status Report' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#General_Safety_Meeting_Material
General Safety Meeting Material
'General Safety Meeting Material' SubClassOf 'General Safety Reporting'
http://www.CareLex.org/2012/carelex.owl#Independent_Data_Monitoring_Committee_Charter
Independent Data Monitoring Committee Charter
'Independent Data Monitoring Committee Charter' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2012/carelex.owl#Investigator_Confidentiality_Agreement
Investigator Confidentiality Agreement
'Investigator Confidentiality Agreement' SubClassOf 'Site Selection'
http://www.CareLex.org/2012/carelex.owl#Clinical_Trial_Agreement
Clinical Trial Agreement
'Clinical Trial Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#General_IP_Documents
General IP Documents
'General IP Documents' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2012/carelex.owl#Subject_Information_Form
Subject Information Form
'Subject Information Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#Data_Validation_Testing
Data Validation Testing
'Data Validation Testing' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Communications
General Central Trial Communications
'General Central Trial Communications' SubClassOf 'General Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Kick-off_Meeting_Material
Kick-off Meeting Material
'Kick-off Meeting Material' SubClassOf 'Trial Management Meeting Documents'
http://www.CareLex.org/2012/carelex.owl#Specimen_Label
Specimen Label
'Specimen Label' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2012/carelex.owl#Database_Specification
Database Specification
'Database Specification' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#Lab_Manual
Lab Manual
'Lab Manual' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#Certificate_of_Analysis
Certificate of Analysis
'Certificate of Analysis' SubClassOf 'IP Release Process'
http://www.CareLex.org/2012/carelex.owl#Vendor_Records
Vendor Records
'Vendor Records' SubClassOf 'Vendors'
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC
General IRB-IEC
'General IRB-IEC' SubClassOf 'eTMF'
http://www.CareLex.org/2012/carelex.owl#SAE_Report_
SAE Report
'SAE Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2012/carelex.owl#General_Site_Management
General Site Management
'General Site Management' SubClassOf 'Site Management'
http://www.CareLex.org/2012/carelex.owl#Bioanalytical_Reports
Bioanalytical Reports
'Bioanalytical Reports' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#Data_Validation_Certification
Data Validation Certification
'Data Validation Certification' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#General_Trial_Management_Communications
General Trial Management Communications
'General Trial Management Communications' SubClassOf 'General Trial Management Documents'
http://www.CareLex.org/2012/carelex.owl#Approval
Approval
'Approval' SubClassOf 'Trial Approval'
http://www.CareLex.org/2012/carelex.owl#Serious_Adverse_Event_Reconciliation
Serious Adverse Event Reconciliation
'Serious Adverse Event Reconciliation' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Communications
General Data Management Communications
'General Data Management Communications' SubClassOf 'General Data Management'
http://www.CareLex.org/2012/carelex.owl#IRT_User_Requirement_Specification
IRT User Requirement Specification
'IRT User Requirement Specification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2012/carelex.owl#General_Statistics_Communications
General Statistics Communications
'General Statistics Communications' SubClassOf 'General Statistics'
http://www.CareLex.org/2012/carelex.owl#Supply_Import_Documentation
Supply Import Documentation
'Supply Import Documentation' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2012/carelex.owl#General_Data_Management_Filenote
General Data Management Filenote
'General Data Management Filenote' SubClassOf 'General Data Management'
http://www.CareLex.org/2012/carelex.owl#Other_Submissions
Other Submissions
'Other Submissions' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2012/carelex.owl#Independent_Data_Monitoring_Committee_Member_List
Independent Data Monitoring Committee Member List
'Independent Data Monitoring Committee Member List' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2012/carelex.owl#Filenote_Master_List
Filenote Master List
'Filenote Master List' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Randomization_Plan
Randomization Plan
'Randomization Plan' SubClassOf 'Randomization'
http://www.CareLex.org/2012/carelex.owl#List_of_SOPs_Current_During_Trial
List of SOPs Current During Trial
'List of SOPs Current During Trial' SubClassOf 'Trial Oversight'
http://www.CareLex.org/2012/carelex.owl#Regulatory_Submission
Regulatory Submission
'Regulatory Submission' SubClassOf 'Trial Approval'
http://www.CareLex.org/2012/carelex.owl#Protocol_Synopsis
Protocol Synopsis
'Protocol Synopsis' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Template_Advertisement_for_Subject_Recruitment
Template Advertisement for Subject Recruitment
'Template Advertisement for Subject Recruitment' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2012/carelex.owl#Notification_of_Trial_Termination
Notification of Trial Termination
'Notification of Trial Termination' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2012/carelex.owl#General_IRB-IEC_Communications
General IRB-IEC Communications
'General IRB-IEC Communications' SubClassOf 'IRB-IEC Sponsor Communications'
http://www.CareLex.org/2012/carelex.owl#Site_Signature_Sheet
Site Signature Sheet
'Site Signature Sheet' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Notification_to_Investigators_of_Safety_Information
Notification to Investigators of Safety Information
'Notification to Investigators of Safety Information' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2012/carelex.owl#Sample_Export_Documentation
Sample Export Documentation
'Sample Export Documentation' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2012/carelex.owl#Trial_Team
Trial Team
'Trial Team' SubClassOf 'Trial Management'
http://www.CareLex.org/2012/carelex.owl#Data_Clarification_Forms
Data Clarification Forms
'Data Clarification Forms' SubClassOf 'Data Capture'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Radiography
Study Subject Radiography
'Study Subject Radiography' SubClassOf 'Radiography'
http://www.CareLex.org/2012/carelex.owl#General_Central_Trial_Filenote
General Central Trial Filenote
'General Central Trial Filenote' SubClassOf 'General Central Trial Documents'
http://www.CareLex.org/2012/carelex.owl#Edit_Check_Programming
Edit Check Programming
'Edit Check Programming' SubClassOf 'Database'
http://www.CareLex.org/2012/carelex.owl#Adjudication_Committee_Document
Adjudication Committee Document
'Adjudication Committee Document' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2012/carelex.owl#Study_Subject_Medical_Imaging_Report
Study Subject Medical Imaging Report
'Study Subject Medical Imaging Report' SubClassOf 'Medical Imaging Other'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Radiography_Report
Study Subject Radiography Report
'Study Subject Radiography Report' SubClassOf 'Radiography'
http://www.CareLex.org/2016/carelex.owl#Edit_Check_Programming
Edit Check Programming
'Edit Check Programming' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_CT_Report
Study Subject CT Report
'Study Subject CT Report' SubClassOf 'Computed Tomography'
http://www.CareLex.org/2016/carelex.owl#Financial_Documentation
Financial Documentation
'Financial Documentation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Investigator_Newsletter
Investigator Newsletter
'Investigator Newsletter' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Statistics_Oversight
Statistics Oversight
'Statistics Oversight' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#IP_Transfer_Record
IP Transfer Record
'IP Transfer Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Sample_Storage_Condition_Log
Sample Storage Condition Log
'Sample Storage Condition Log' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Form_FDA_1572
Form FDA 1572
'Form FDA 1572' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Local_Laboratory_Normal_Ranges
Local Laboratory Normal Ranges
'Local Laboratory Normal Ranges' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Shipment_Record
IP Shipment Record
'IP Shipment Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Trial_Master_File_Plan
Trial Master File Plan
'Trial Master File Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Database
Database
'Database' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Protocol_Amendment
Protocol Amendment
'Protocol Amendment' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Investigator_Documents
Investigator Documents
'Investigator Documents' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Central_Trial_Final_Reports
Central Trial Final Reports
'Central Trial Final Reports' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Meeting_Material
Central Trial Meeting Material
'Central Trial Meeting Material' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Ultrasound
Ultrasound
'Ultrasound' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Monitoring_Plan
Monitoring Plan
'Monitoring Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Site_Signature_Sheet
Site Signature Sheet
'Site Signature Sheet' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Regulatory_Status_Reporting
Trial Regulatory Status Reporting
'Trial Regulatory Status Reporting' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Statistical_Report_Records
Statistical Report Records
'Statistical Report Records' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Filenote
IP and Trial Supplies Filenote
'IP and Trial Supplies Filenote' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Monitoring_Visit_Follow-up_Letter
Monitoring Visit Follow-up Letter
'Monitoring Visit Follow-up Letter' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Meeting_Material
Regulatory Meeting Material
'Regulatory Meeting Material' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Subject_Participation_Form
Subject Participation Form
'Subject Participation Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Evidence_of_Contractor_Compliance_
Evidence of Contractor Compliance
'Evidence of Contractor Compliance' SubClassOf 'Vendor Oversight'
http://www.CareLex.org/2016/carelex.owl#Trial_Safety_Status_Reporting
Trial Safety Status Reporting
'Trial Safety Status Reporting' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2016/carelex.owl#Template_Advertisement_for_Subject_Recruitment
Clinical Trial Subject Recruitment Advertisement
'Clinical Trial Subject Recruitment Advertisement' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Meeting_Material
Site Management Meeting Material
'Site Management Meeting Material' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Report_of_Prior_Investigations
Report of Prior Investigations
'Report of Prior Investigations' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#License
License
'License' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#List_of_SOPs_Current_During_Trial
SOP List
'SOP List' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#External_Data_Transfer_Specifications
External Data Transfer Specifications
'External Data Transfer Specifications' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Site_Initiation
Site Initiation
'Site Initiation' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Device_Review_Committee
Device Review Committee
'Device Review Committee' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Nuclear_Medicine
Study Subject Nuclear Medicine
'Study Subject Nuclear Medicine' SubClassOf 'Nuclear Medicine'
http://www.CareLex.org/2016/carelex.owl#Statistical_Report
Statistical Report
'Statistical Report' SubClassOf 'Statistical Report Records'
http://www.CareLex.org/2016/carelex.owl#Sample_Size_Calculation
Sample Size Calculation
'Sample Size Calculation' SubClassOf 'Statistics Oversight'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Filenote
Site Management Filenote
'Site Management Filenote' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Subject_Unblinding_Event
Subject Unblinding Event
'Subject Unblinding Event' SubClassOf 'IP Randomization'
http://www.CareLex.org/2016/carelex.owl#Annotated_Case_Report_Form
Annotated Case Report Form
'Annotated Case Report Form' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Participation
IRB-IEC Approved Subject Participation
'IRB-IEC Approved Subject Participation' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Other_non-IDMC_Trial_Committee_Document
Non-IDMC Trial Committee Documents Unspecified
'Non-IDMC Trial Committee Documents Unspecified' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Subject_Unblinding_Plan
Subject Unblinding Plan
'Subject Unblinding Plan' SubClassOf 'IP Randomization'
http://www.CareLex.org/2016/carelex.owl#Dictionary_Coding
Dictionary Coding
'Dictionary Coding' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Notification_of_Trial_Termination
IRB-IEC Notification of Trial Termination
'IRB-IEC Notification of Trial Termination' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Other_Subject_Information
IRB-IEC Approved Other Subject Information
'IRB-IEC Approved Other Subject Information' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Reporting
Safety Reporting Communications and Tracking
'Safety Reporting Communications and Tracking' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2016/carelex.owl#Analysis_QC_Documentation
Analysis QC Documentation
'Analysis QC Documentation' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Datasets
Final Analysis Datasets
'Final Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Report
IRB-IEC Report
'IRB-IEC Report' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_GCP_Compliance_Statement
IRB-IEC GCP Compliance Statement
'IRB-IEC GCP Compliance Statement' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Certification
Laboratory Certification
'Laboratory Certification' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Notification_of_Safety_Information
Notification of Safety Information
'Notification of Safety Information' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Case_Report_Form
Case Report Form
'Case Report Form' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Radiography
Radiography
'Radiography' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Financial_Disclosure_Summary
Financial Disclosure Summary
'Financial Disclosure Summary' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Shipment_Records
Laboratory Shipment Records
'Laboratory Shipment Records' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Study_Registry_Documents
Study Registry Documents
'Study Registry Documents' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory
Regulatory Documentation Communications and Tracking
'Regulatory Documentation Communications and Tracking' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Site_Personnel_Supporting_Information
Site Personnel Supporting Information
'Site Personnel Supporting Information' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Medical_Imaging
Study Subject Medical Imaging Unspecified
'Study Subject Medical Imaging Unspecified' SubClassOf 'Medical Imaging Unspecified'
http://www.CareLex.org/2016/carelex.owl#Quality_Plan
Quality Plan
'Quality Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Communications
Regulatory Communications
'Regulatory Communications' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Communication_Plan
Communication Plan
'Communication Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Insurance
Insurance
'Insurance' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Meeting_Material
Statistics Meeting Material
'Statistics Meeting Material' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Central_Trial_Documents
Central Trial Documents
'Central Trial Documents' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Tracking_Document
IRB-IEC Tracking Document
'IRB-IEC Tracking Document' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Risk_Management_Plan
Risk Management Plans
'Risk Management Plans' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Source_Data
Source Data
'Source Data' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_CT
Study Subject CT
'Study Subject CT' SubClassOf 'Computed Tomography'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Meeting_Material
Trial Management Meeting Material
'Trial Management Meeting Material' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Approval_for_Database_Activation
Approval for Database Activation
'Approval for Database Activation' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Safety_Documentation
Safety Documentation
'Safety Documentation' SubClassOf 'Safety Reporting'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Director_Curriculum_Vitae
Laboratory Director Curriculum Vitae
'Laboratory Director Curriculum Vitae' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Sub-Investigator_Curriculum_Vitae
Sub-Investigator Curriculum Vitae
'Sub-Investigator Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Data_Definitions_for_Analysis_Datasets
Data Definitions for Analysis Datasets
'Data Definitions for Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Meeting_Material
Centralized Testing Meeting Material
'Centralized Testing Meeting Material' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Tracking_Document
Vendor Tracking Document
'Vendor Tracking Document' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Source_Data_Verification
Source Data Verification
'Source Data Verification' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Computed_Tomography
Computed Tomography
'Computed Tomography' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Other_Subject_Forms
Other Subject Forms
'Other Subject Forms' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Data_Management_Oversight
Data Management Oversight
'Data Management Oversight' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Output
Interim Analysis Output
'Interim Analysis Output' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Vendor_Confidentiality_Agreement
Vendor Confidentiality Agreement
'Vendor Confidentiality Agreement' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#Pre_Trial_Monitoring_Report
Pre Trial Monitoring Report
'Pre Trial Monitoring Report' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Output
Final Analysis Output
'Final Analysis Output' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#IP_Recall_Plan
IP Recall Plan
'IP Recall Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Contractual_Agreement
Contractual Agreement
'Contractual Agreement' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#Regulatory
Regulatory Documentation
'Regulatory Documentation' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Investigational_Medicinal_Product
Investigational Medicinal Product
'Investigational Medicinal Product' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Protocol_Amendment_Signature_Page
Protocol Amendment Signature Page
'Protocol Amendment Signature Page' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Record_of_Retained_Body_Fluids_or_Tissue_Samples
Record of Retained Body Fluids or Tissue Samples
'Record of Retained Body Fluids or Tissue Samples' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#IP_Retest_and_Expiry_Document
IP Retest and Expiry Document
'IP Retest and Expiry Document' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Medical_Monitoring_Plan
Medical Monitoring Plan
'Medical Monitoring Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Nuclear_Medicine_Report
Study Subject Nuclear Medicine Report
'Study Subject Nuclear Medicine Report' SubClassOf 'Nuclear Medicine'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Advertisement_for_Subject_Recruitment
IRB-IEC Approved Advertisement for Subject Recruitment
'IRB-IEC Approved Advertisement for Subject Recruitment' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Documentation_of_Return__
Non-IP Documentation of Return
'Non-IP Documentation of Return' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Site_Selection
Site Selection
'Site Selection' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Trial_Initiation_Monitoring_Report
Trial Initiation Monitoring Report
'Trial Initiation Monitoring Report' SubClassOf 'Site Initiation'
http://www.CareLex.org/2016/carelex.owl#General_Vendors
Vendors Communications and Tracking
'Vendors Communications and Tracking' SubClassOf 'Vendors'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Manual
IRT User Manual
'IRT User Manual' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Roles_and_Responsibilities_Matrix
Vendor Roles and Responsibilities
'Vendor Roles and Responsibilities' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Raw_Datasets
Interim Analysis Raw Datasets
'Interim Analysis Raw Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Subject_Questionnaire_Form
Subject Questionnaire Form
'Subject Questionnaire Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Final_Trial_Close_Out_Monitoring_Report
Final Trial Close Out Monitoring Report
'Final Trial Close Out Monitoring Report' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Management
Trial Management
'Trial Management' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Acceptance_of_Investigator_Brochure
Acceptance of Investigator Brochure
'Acceptance of Investigator Brochure' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Instructions_for_Handling
IP Instructions for Handling
'IP Instructions for Handling' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Communications
Site Management Communications
'Site Management Communications' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Subject_Enrollment_Log
Subject Enrollment Log
'Subject Enrollment Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Bioanalytical_Validation_Methods
Bioanalytical Validation Methods
'Bioanalytical Validation Methods' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Testing
Centralized Testing Communications and Tracking
'Centralized Testing Communications and Tracking' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2016/carelex.owl#IP_Site_Release_Documentation
IP Site Release Documentation
'IP Site Release Documentation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Supply_Storage_Condition_Excursions
Trial Supply Storage Condition Excursions
'Trial Supply Storage Condition Excursions' SubClassOf 'Trial Supply Storage'
http://www.CareLex.org/2016/carelex.owl#Publication_Policy
Publication Policy
'Publication Policy' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Ultrasound_Report
Study Subject Ultrasound Report
'Study Subject Ultrasound Report' SubClassOf 'Ultrasound'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Programs
Interim Analysis Programs
'Interim Analysis Programs' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Documentation_of_Shipment_
Non-IP Documentation of Shipment
'Non-IP Documentation of Shipment' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Study_Site_Personnel_Details
Study Site Personnel Details
'Study Site Personnel Details' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Subject_Screen_Log
Subject Screen Log
'Subject Screen Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Financial_Disclosure_Form
Financial Disclosure Form
'Financial Disclosure Form' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Database_Lock_and_Unlock_Approval
Database Lock and Unlock Approval
'Database Lock and Unlock Approval' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Ultrasound
Study Subject Ultrasound
'Study Subject Ultrasound' SubClassOf 'Ultrasound'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Testing_Communications
Centralized Testing Communications
'Centralized Testing Communications' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IP_Documentation
IP Documentation
'IP Documentation' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Tracking_Document
Data Management Tracking Document
'Data Management Tracking Document' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Independent_Data_Monitoring_Committee_Correspondence
Independent Data Monitoring Committee Correspondence
'Independent Data Monitoring Committee Correspondence' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Certificate_of_Destruction
Certificate of Destruction
'Certificate of Destruction' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Documents
Trial Management Documents Communications and Tracking
'Trial Management Documents Communications and Tracking' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Other_Approvals
Other Approvals
'Other Approvals' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Subject_Identification_Log
Subject Identification Log
'Subject Identification Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Database_Quality_Plan
Database Quality Plan
'Database Quality Plan' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Electronic_Data_Capture_Final_Data
Electronic Data Capture Final Data
'Electronic Data Capture Final Data' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#Special_Events_of_Interest
Special Events of Interest
'Special Events of Interest' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Tracking_Document
Safety Tracking Document
'Safety Tracking Document' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#End_of_Trial
Trial Unblinding
'Trial Unblinding' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#Master_Randomization_List
Master Randomization List
'Master Randomization List' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Notifications
IRT User Notifications
'IRT User Notifications' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Supply_Plan_
Non-IP Supply Plan
'Non-IP Supply Plan' SubClassOf 'Non-IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Randomization
Randomization
'Randomization' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#Import-Export_License_Application
Import-Export License Application
'Import-Export License Application' SubClassOf 'Investigational Medicinal Product'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Raw_Datasets
Final Analysis Raw Datasets
'Final Analysis Raw Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Database_Change_Control
Database Change Control
'Database Change Control' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Documents
Central Trial Documents Communications and Tracking
'Central Trial Documents Communications and Tracking' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Communications
IP and Trial Supplies Communications
'IP and Trial Supplies Communications' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Recruitment_Plan
Recruitment Plan
'Recruitment Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Trial_Supply_Storage
Trial Supply Storage
'Trial Supply Storage' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Composition
IRB-IEC Composition
'IRB-IEC Composition' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Communications
Safety Communications
'Safety Communications' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Normal_Ranges
Normal Ranges
'Normal Ranges' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Filenote
Safety Filenote
'Safety Filenote' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Trial_Approval
Trial Approval
'Trial Approval' SubClassOf 'Regulatory Documentation'
http://www.CareLex.org/2016/carelex.owl#Non-IP_Documentation
Non-IP Documentation
'Non-IP Documentation' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#IP_Supply_Plan
IP Supply Plan
'IP Supply Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Return_Record
IP Return Record
'IP Return Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Questionnaire
IRB-IEC Approved Subject Questionnaire
'IRB-IEC Approved Subject Questionnaire' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Interactive_Response_Technology
Interactive Response Technology
'Interactive Response Technology' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Vendor_Oversight
Vendor Oversight
'Vendor Oversight' SubClassOf 'Vendors'
http://www.CareLex.org/2016/carelex.owl#Informed_Consent_Form
Informed Consent Form
'Informed Consent Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Vendors
Vendors
'Vendors' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Investigator_Brochure
Investigator Brochure
'Investigator Brochure' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Communications
IRB-IEC Communications
'IRB-IEC Communications' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Investigators_Meeting_Material
Investigators Meeting Material
'Investigators Meeting Material' SubClassOf 'Trial Start Up'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Testing_Filenote
Centralized Testing Filenote
'Centralized Testing Filenote' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IRB/IEC_Progress_Report
IRB-IEC Progress Report
'IRB-IEC Progress Report' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Acceptance_Testing_Certification
IRT User Acceptance Testing Certification
'IRT User Acceptance Testing Certification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Life_Sciences
Life Sciences
http://www.CareLex.org/2016/carelex.owl#Study_Subject_MRI_Report
Study Subject MRI Report
'Study Subject MRI Report' SubClassOf 'Magnetic Resonance Imaging'
http://www.CareLex.org/2016/carelex.owl#Regulatory_Report
Regulatory Report
'Regulatory Report' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management
Data Management Communications and Tracking
'Data Management Communications and Tracking' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Statistics
Statistics
'Statistics' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Data_Management_Plan
Data Management Plan
'Data Management Plan' SubClassOf 'Data Management Oversight'
http://www.CareLex.org/2016/carelex.owl#Medical_Imaging
Medical Imaging
'Medical Imaging' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Trial_Status_Reporting
IRB-IEC Trial Status Reporting
'IRB-IEC Trial Status Reporting' SubClassOf 'IRB-IEC and Other Approvals'
http://www.CareLex.org/2016/carelex.owl#Dose_Escalation
Dose Escalation Documents
'Dose Escalation Documents' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#General_Statistics
Statistics Communication and Tracking
'Statistics Communication and Tracking' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#Interfacility_Standardization_Methods
Interfacility Standardization Methods
'Interfacility Standardization Methods' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Meeting_Material
IP and Trial Supplies Meeting Material
'IP and Trial Supplies Meeting Material' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Submission
IRB-IEC Submission
'IRB-IEC Submission' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Expedited_Safety_Report
Expedited Safety Report
'Expedited Safety Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Centralized_Testing
Centralized Testing
'Centralized Testing' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Safety_Management_Plan
Safety Management Plan
'Safety Management Plan' SubClassOf 'Safety Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Quality_Complaint_Form
IP Quality Complaint Form
'IP Quality Complaint Form' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Release_Process
IP Release Process
'IP Release Process' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Laboratory_Sample_Details
Laboratory Sample Details
'Laboratory Sample Details' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2016/carelex.owl#Operational_Procedure_Manual
Operational Procedure Manual
'Operational Procedure Manual' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#IRT_Validation_Certification
IRT Validation Certification
'IRT Validation Certification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Analysis
Analysis
'Analysis' SubClassOf 'Statistics'
http://www.CareLex.org/2016/carelex.owl#General_IP_and_Trial_Supplies_Tracking_Document
IP and Trial Supplies Tracking Document
'IP and Trial Supplies Tracking Document' SubClassOf 'IP Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Randomization_Procedure
Randomization Procedure
'Randomization Procedure' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Filenote
Regulatory Filenote
'Regulatory Filenote' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Interim_Statistical_Reports
Interim Statistical Reports
'Interim Statistical Reports' SubClassOf 'Statistical Report Records'
http://www.CareLex.org/2016/carelex.owl#Trial_Team_Details
Trial Team Details
'Trial Team Details' SubClassOf 'Trial Team'
http://www.CareLex.org/2016/carelex.owl#Protocol_Signature_Page
Protocol Signature Page
'Protocol Signature Page' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Audit_Certificate
Audit Certificate
'Audit Certificate' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Indemnity
Indemnity
'Indemnity' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Communications
Vendor Communications
'Vendor Communications' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Tracking_Document
Statistics Tracking Document
'Statistics Tracking Document' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Notification_to_IRB-IEC_of_Safety_Information
Notification to IRB-IEC of Safety Information
'Notification to IRB-IEC of Safety Information' SubClassOf 'IRB-IEC Trial Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Pharmacokinetics_Report
Pharmacokinetics Report
'Pharmacokinetics Report' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2016/carelex.owl#Protocol
Protocol
'Protocol' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Database_Account_Management
Database Account Management
'Database Account Management' SubClassOf 'EDC Management'
http://www.CareLex.org/2016/carelex.owl#Randomization_Programming
Randomization Programming
'Randomization Programming' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#General_IP_Documents
IP Documents Communications and Tracking
'IP Documents Communications and Tracking' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Data_Capture
Data Capture
'Data Capture' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Diary
IRB-IEC Approved Subject Diary
'IRB-IEC Approved Subject Diary' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Site_Training_Material
Site Training Material
'Site Training Material' SubClassOf 'Site Initiation'
http://www.CareLex.org/2016/carelex.owl#Trial_Oversight
Trial Operations
'Trial Operations' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Safety_Reporting
Safety Reporting
'Safety Reporting' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#Nuclear_Medicine
Nuclear Medicine
'Nuclear Medicine' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Protocol_Deviations
Protocol Deviations
'Protocol Deviations' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Tracking_Document
Central Trial Tracking Document
'Central Trial Tracking Document' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IP_Sample_Label
IP Sample Label
'IP Sample Label' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Qualified_Person_Certification
Qualified Person Certification
'Qualified Person Certification' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#IP_Accountability_Record
IP Accountability Record
'IP Accountability Record' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Local_Laboratory_Certification_or_Accreditation
Local Laboratory Certification or Accreditation
'Local Laboratory Certification or Accreditation' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Trial_Management_Plan
Trial Management Plan
'Trial Management Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Data_Entry_Guidelines
Data Entry Guidelines
'Data Entry Guidelines' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Feasibility_Documentation
Feasibility Documentation
'Feasibility Documentation' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Vendor_Selection
Vendor Selection
'Vendor Selection' SubClassOf 'Vendor Records'
http://www.CareLex.org/2016/carelex.owl#CRF_Completion_Requirements
CRF Completion Requirements
'CRF Completion Requirements' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Filenote
Trial Filenote
'Trial Filenote' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Subject_Information
IRB-IEC Approved Subject Information
'IRB-IEC Approved Subject Information' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#eTMF
eTMF
'eTMF' SubClassOf 'Life Sciences'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Meeting_Material
Vendor Meeting Material
'Vendor Meeting Material' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Magnetic_Resonance_Imaging
Magnetic Resonance Imaging
'Magnetic Resonance Imaging' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Digital_Photographs
Digital Photographs
'Digital Photographs' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Tracking_Document
Trial Management Tracking Documents
'Trial Management Tracking Documents' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Pharmacovigilance_Database_Line_Listing
Pharmacovigilance Database Line Listing
'Pharmacovigilance Database Line Listing' SubClassOf 'Safety Documentation'
http://www.CareLex.org/2016/carelex.owl#IP_Re-labeling_Plan
IP Re-labeling Plan
'IP Re-labeling Plan' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Documentation_of_Non-Voting_Status
IRB-IEC Documentation of Non-Voting Status
'IRB-IEC Documentation of Non-Voting Status' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Core_Trial_Documents
Core Trial Documents
'Core Trial Documents' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Statistical_Analysis_Plan
Statistical Analysis Plan
'Statistical Analysis Plan' SubClassOf 'Statistics Oversight'
http://www.CareLex.org/2016/carelex.owl#Notification_of_Regulatory_Identification_Number
Notification of Regulatory Identification Number
'Notification of Regulatory Identification Number' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approval
IRB-IEC Approval
'IRB-IEC Approval' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Randomization_Plan
IP Randomization Plan
'IP Randomization Plan' SubClassOf 'IP Randomization'
http://www.CareLex.org/2016/carelex.owl#Trial_Management_Meeting_Documents
Trial Start Up
'Trial Start Up' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Subject_Evaluability_Criteria_and_Subject_Classification
Subject Evaluability Criteria and Subject Classification
'Subject Evaluability Criteria and Subject Classification' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#TSE_Statement
TSE Statement
'TSE Statement' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Filenote
Statistics Filenote
'Statistics Filenote' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Other_Financial_Agreement
Other Financial Agreement
'Other Financial Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Clinical_Study_Report
Clinical Study Report
'Clinical Study Report' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Meeting_Material
IRB-IEC Meeting Material
'IRB-IEC Meeting Material' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Trial_Supply_Storage_Conditions
Trial Supply Storage Conditions
'Trial Supply Storage Conditions' SubClassOf 'Trial Supply Storage'
http://www.CareLex.org/2016/carelex.owl#Visit_Log
Visit Log
'Visit Log' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Investigator_Regulatory_Agreement
Investigator Regulatory Agreement
'Investigator Regulatory Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IP_Randomization
IP Randomization
'IP Randomization' SubClassOf 'IP and Trial Supplies'
http://www.CareLex.org/2016/carelex.owl#Trial_Team_Curriculum_Vitae
Trial Team Member CV
'Trial Team Member CV' SubClassOf 'Trial Team'
http://www.CareLex.org/2016/carelex.owl#Subject_Document_Forms
Subject Document Forms
'Subject Document Forms' SubClassOf 'Central Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Photos
Study Subject Digital Photos
'Study Subject Digital Photos' SubClassOf 'Digital Photographs'
http://www.CareLex.org/2016/carelex.owl#Clinical_Trial_Oversight_Committees
Clinical Trial Oversight Committees
'Clinical Trial Oversight Committees' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Subject_Diary_Form
Subject Diary
'Subject Diary' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Monitoring_Visit_Report
Monitoring Visit Report
'Monitoring Visit Report' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Data_Management
Data Management
'Data Management' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_Centralized_Tracking_Document
Centralized Testing Tracking Document
'Centralized Testing Tracking Document' SubClassOf 'Centralized Testing Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Import-Export_License
Import-Export License
'Import-Export License' SubClassOf 'Investigational Medicinal Product'
http://www.CareLex.org/2016/carelex.owl#Adjudication_Committee_Document
Adjudication Committee Document
'Adjudication Committee Document' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Facility_Documentation
Facility Documentation
'Facility Documentation' SubClassOf 'Centralized Testing'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Documents
IRB-IEC Documents
'IRB-IEC Documents' SubClassOf 'IRB-IEC and Other Approvals'
http://www.CareLex.org/2016/carelex.owl#Submissions_Non-IRB-IEC_Committees
Submissions Non-IRB-IEC Committees
'Submissions Non-IRB-IEC Committees' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Communications
Central Trial Communications
'Central Trial Communications' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_MRI
Study Subject MRI
'Study Subject MRI' SubClassOf 'Magnetic Resonance Imaging'
http://www.CareLex.org/2016/carelex.owl#Sample_Export_Documentation
Sample Export Documentation
'Sample Export Documentation' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Completed_Case_Report_Forms
Completed Case Report Forms
'Completed Case Report Forms' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#EDC_Management
EDC Management
'EDC Management' SubClassOf 'Data Management'
http://www.CareLex.org/2016/carelex.owl#Sites_Evaluated_but_not_Selected
Sites Evaluated but not Selected
'Sites Evaluated but not Selected' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Interim_Analysis_Datasets
Interim Analysis Datasets
'Interim Analysis Datasets' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#Data_Privacy_Agreement
Data Privacy Agreement
'Data Privacy Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Meeting_Material
Data Management Meeting Material
'Data Management Meeting Material' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC_Filenote
IRB-IEC Filenote
'IRB-IEC Filenote' SubClassOf 'IRB-IEC Sponsor Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#SAE_Report_
SAE Report
'SAE Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Bioanalytical_Reports
Bioanalytical Reports
'Bioanalytical Reports' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management_Tracking_Document
Site Management Tracking Document
'Site Management Tracking Document' SubClassOf 'Site Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Clinical_Study_Report_Synopsis
Clinical Study Report Synopsis
'Clinical Study Report Synopsis' SubClassOf 'Central Trial Final Reports'
http://www.CareLex.org/2016/carelex.owl#IP_and_Trial_Supplies
IP and Trial Supplies
'IP and Trial Supplies' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_Site_Management
Site Management Communications and Tracking
'Site Management Communications and Tracking' SubClassOf 'Site Management'
http://www.CareLex.org/2016/carelex.owl#Trial_Status_Report
Trial Status Report
'Trial Status Report' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Final_Analysis_Programs
Final Analysis Programs
'Final Analysis Programs' SubClassOf 'Analysis'
http://www.CareLex.org/2016/carelex.owl#General_IRB-IEC
IRB-IEC and Other Approvals
'IRB-IEC and Other Approvals' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Sponsor_Communications
IRB-IEC Sponsor Communications and Tracking
'IRB-IEC Sponsor Communications and Tracking' SubClassOf 'IRB-IEC and Other Approvals'
http://www.CareLex.org/2016/carelex.owl#IP_Device_Maintenance_Log
IP Device Maintenance Log
'IP Device Maintenance Log' SubClassOf 'IP Documentation'
http://www.CareLex.org/2016/carelex.owl#Medical_Imaging_Other
Medical Imaging Unspecified
'Medical Imaging Unspecified' SubClassOf 'Medical Imaging'
http://www.CareLex.org/2016/carelex.owl#Specimen_Label
Specimen Label
'Specimen Label' SubClassOf 'Laboratory Sample Details'
http://www.CareLex.org/2016/carelex.owl#Certificate_of_Analysis
Certificate of Analysis
'Certificate of Analysis' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#Database_Specification
Database Specification
'Database Specification' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Investigator_Confidentiality_Agreement
Site Related Confidentiality Agreement
'Site Related Confidentiality Agreement' SubClassOf 'Site Selection'
http://www.CareLex.org/2016/carelex.owl#Debarment_Statement
Debarment Statement
'Debarment Statement' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Trial_Team_Training_Material
Trial Team Training Material
'Trial Team Training Material' SubClassOf 'Trial Start Up'
http://www.CareLex.org/2016/carelex.owl#General_Vendor_Filenote
Vendor Filenote
'Vendor Filenote' SubClassOf 'Vendors Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Principal_Investigator_Curriculum_Vitae
Principal Investigator Curriculum Vitae
'Principal Investigator Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Randomization_Validation
Randomization Validation
'Randomization Validation' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#Site_Training_Documentation
Site Training Documentation
'Site Training Documentation' SubClassOf 'Site Initiation'
http://www.CareLex.org/2016/carelex.owl#Data_Validation_Certification
Data Validation Certification
'Data Validation Certification' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Data_Validation_Testing
Data Validation Testing
'Data Validation Testing' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#General_Trial_Management_Communications
Trial Management Communications
'Trial Management Communications' SubClassOf 'Trial Management Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Lab_Manual
Lab Manual
'Lab Manual' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Pregnancy_Report
Pregnancy Report
'Pregnancy Report' SubClassOf 'Trial Safety Status Reporting'
http://www.CareLex.org/2016/carelex.owl#IRB-IEC_Approved_Informed_Consent
IRB-IEC Approved Informed Consent
'IRB-IEC Approved Informed Consent' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Vendor_Records
Vendor Records
'Vendor Records' SubClassOf 'Vendors'
http://www.CareLex.org/2016/carelex.owl#Kick-off_Meeting_Material
Kick-off Meeting Material
'Kick-off Meeting Material' SubClassOf 'Trial Start Up'
http://www.CareLex.org/2016/carelex.owl#IP_Regulatory_Release
IP Regulatory Release
'IP Regulatory Release' SubClassOf 'IP Release Process'
http://www.CareLex.org/2016/carelex.owl#Independent_Data_Monitoring_Committee_Charter
Independent Data Monitoring Committee Charter
'Independent Data Monitoring Committee Charter' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Investigators_Agreement_-_Device
Device Investigators Agreement
'Device Investigators Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Safety_Meeting_Material
Safety Meeting Material
'Safety Meeting Material' SubClassOf 'Safety Reporting Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Medical_Imaging_Report
Study Subject Medical Imaging Report Unspecified
'Study Subject Medical Imaging Report Unspecified' SubClassOf 'Medical Imaging Unspecified'
http://www.CareLex.org/2016/carelex.owl#Study_Team_Curriculum_Vitae
Study Team Curriculum Vitae
'Study Team Curriculum Vitae' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#IRT_User_Requirement_Specification
IRT User Requirement Specification
'IRT User Requirement Specification' SubClassOf 'Interactive Response Technology'
http://www.CareLex.org/2016/carelex.owl#Subject_Information_Form
Subject Information Form
'Subject Information Form' SubClassOf 'Subject Document Forms'
http://www.CareLex.org/2016/carelex.owl#Serious_Adverse_Event_Reconciliation
Serious Adverse Event Reconciliation
'Serious Adverse Event Reconciliation' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Other_Submissions
Other Submissions
'Other Submissions' SubClassOf 'IRB-IEC Documents'
http://www.CareLex.org/2016/carelex.owl#Approval
Approval
'Approval' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#Trial_Team
Trial Team
'Trial Team' SubClassOf 'Trial Management'
http://www.CareLex.org/2016/carelex.owl#Clinical_Trial_Agreement
Clinical Trial Agreement
'Clinical Trial Agreement' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#Vendor_Managment_Plan
Vendor Management Plan
'Vendor Management Plan' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Filenote_Master_List
Filenote Master List
'Filenote Master List' SubClassOf 'Trial Operations'
http://www.CareLex.org/2016/carelex.owl#Supply_Import_Documentation
Lab Supply Import Documentation
'Lab Supply Import Documentation' SubClassOf 'Facility Documentation'
http://www.CareLex.org/2016/carelex.owl#Independent_Data_Monitoring_Committee_Member_List
Independent Data Monitoring Committee Member List
'Independent Data Monitoring Committee Member List' SubClassOf 'Clinical Trial Oversight Committees'
http://www.CareLex.org/2016/carelex.owl#Protocol_Synopsis
Protocol Synopsis
'Protocol Synopsis' SubClassOf 'Core Trial Documents'
http://www.CareLex.org/2016/carelex.owl#Data_Validation_Plan
Data Validation Plan
'Data Validation Plan' SubClassOf 'Database'
http://www.CareLex.org/2016/carelex.owl#Technical_Design_Document
Technical Design Document
'Technical Design Document' SubClassOf 'EDC Management'
http://www.CareLex.org/2016/carelex.owl#Site_Management
Site Management
'Site Management' SubClassOf 'eTMF'
http://www.CareLex.org/2016/carelex.owl#General_Regulatory_Tracking_Document
Regulatory Tracking Document
'Regulatory Tracking Document' SubClassOf 'Regulatory Documentation Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Notification_of_Trial_Termination
Regulatory Notification of Trial Termination
'Regulatory Notification of Trial Termination' SubClassOf 'Trial Regulatory Status Reporting'
http://www.CareLex.org/2016/carelex.owl#Randomization_Plan
Randomization Plan
'Randomization Plan' SubClassOf 'Randomization'
http://www.CareLex.org/2016/carelex.owl#Regulatory_Submission
Regulatory Submission
'Regulatory Submission' SubClassOf 'Trial Approval'
http://www.CareLex.org/2016/carelex.owl#Additional_Monitoring_Activity
Supplementary Monitoring Activity
'Supplementary Monitoring Activity' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Filenote
Data Management Filenote
'Data Management Filenote' SubClassOf 'Data Management Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Radiography
Study Subject Radiography
'Study Subject Radiography' SubClassOf 'Radiography'
http://www.CareLex.org/2016/carelex.owl#Data_Clarification_Forms
Data Clarification Forms
'Data Clarification Forms' SubClassOf 'Data Capture'
http://www.CareLex.org/2016/carelex.owl#General_Central_Trial_Filenote
Central Trial Filenote
'Central Trial Filenote' SubClassOf 'Central Trial Documents Communications and Tracking'
http://www.CareLex.org/2016/carelex.owl#General_Statistics_Communications
Statistics Communications
'Statistics Communications' SubClassOf 'Statistics Communication and Tracking'
http://www.CareLex.org/2016/carelex.owl#Study_Subject_Digital_Photos_Report
Study Subject Digital Photos Report
'Study Subject Digital Photos Report' SubClassOf 'Digital Photographs'
http://www.CareLex.org/2016/carelex.owl#Notification_to_Investigators_of_Safety_Information
Notification to Investigators of Safety Information
'Notification to Investigators of Safety Information' SubClassOf 'Investigator Documents'
http://www.CareLex.org/2016/carelex.owl#General_Data_Management_Communications
Data Management Communications
'Data Management Communications' SubClassOf 'Data Management Communications and Tracking'