Veeva Clinical Basics Document Types

Central and Local Testing

Type	Subtype	Classification
Central and Local Testing	Facility Documentation	Certification or Accreditation
Central and Local Testing	Facility Documentation	Head of Facility Curriculum Vitae
Central and Local Testing	Facility Documentation	Laboratory Results Documentation
Central and Local Testing	Facility Documentation	Laboratory Validation Documentation
Central and Local Testing	Facility Documentation	Manual
Central and Local Testing	Facility Documentation	Normal Ranges
Central and Local Testing	Facility Documentation	Standardization Methods
Central and Local Testing	Facility Documentation	Supply Import Documentation
Central and Local Testing	General	Filenote
Central and Local Testing	General	Meeting Material
Central and Local Testing	General	Relevant Communications
Central and Local Testing	General	Tracking Information
Central and Local Testing	Sample Documentation	Record of Retained Samples
Central and Local Testing	Sample Documentation	Sample Import or Export Documentation
Central and Local Testing	Sample Documentation	Sample Storage Condition Log
Central and Local Testing	Sample Documentation	Shipment Records
Central and Local Testing	Sample Documentation	Specimen Label

Central Trial Documents

Type	Subtype	Classification
Central Trial Documents	General	Filenote
Central Trial Documents	General	Meeting Material
Central Trial Documents	General	Relevant Communications
Central Trial Documents	General	Tracking Information
Central Trial Documents	Product and Trial Documentation	Financial Disclosure Summary
Central Trial Documents	Product and Trial Documentation	Insurance
Central Trial Documents	Product and Trial Documentation	Investigator’s Brochure
Central Trial Documents	Product and Trial Documentation	Marketed Product Material
Central Trial Documents	Product and Trial Documentation	Protocol
Central Trial Documents	Product and Trial Documentation	Protocol Clarification Letter
Central Trial Documents	Product and Trial Documentation	Protocol Summary of Changes
Central Trial Documents	Product and Trial Documentation	Protocol Synopsis
Central Trial Documents	Product and Trial Documentation	Report of Prior Investigations
Central Trial Documents	Product and Trial Documentation	Sample Case Report Form
Central Trial Documents	Reports	Bioanalytical Report
Central Trial Documents	Reports	Clinical Study Report
Central Trial Documents	Subject Documentation	Advertisements for Subject Recruitment
Central Trial Documents	Subject Documentation	Informed Consent Form
Central Trial Documents	Subject Documentation	Other Information Given to Subjects
Central Trial Documents	Subject Documentation	Subject Diary
Central Trial Documents	Subject Documentation	Subject Information Sheet
Central Trial Documents	Subject Documentation	Subject Participation Card
Central Trial Documents	Subject Documentation	Subject Questionnaire

Data Management

Type	Subtype	Classification
Data Management	Data Capture	Annotated CRF
Data Management	Data Capture	CRF Completion Requirements
Data Management	Data Capture	Documentation of Corrections to Entered Data
Data Management	Data Capture	Final Subject Data
Data Management	Data Management Oversight	Data Management Plan
Data Management	Database	Approval for Database Activation
Data Management	Database	Data Entry Guidelines (Paper)
Data Management	Database	Data QC or QA Plan and Results
Data Management	Database	Database Change Control
Data Management	Database	Database Lock and Unlock Approval
Data Management	Database	Database Specifications
Data Management	Database	Dictionary Coding
Data Management	Database	Edit Check Plan
Data Management	Database	Edit Check Programming
Data Management	Database	Edit Check Testing
Data Management	Database	External Data Transfer Specifications
Data Management	Database	SAE Reconciliation
Data Management	EDC Management	System Account Management
Data Management	EDC Management	Technical Design Document
Data Management	EDC Management	Validation Documents
Data Management	General	Filenote
Data Management	General	Meeting Material
Data Management	General	Relevant Communications
Data Management	General	Tracking Information

IP and Trial Supplies

Type	Subtype	Classification
IP and Trial Supplies	General	Filenote
IP and Trial Supplies	General	Meeting Material
IP and Trial Supplies	General	Relevant Communications
IP and Trial Supplies	General	Tracking Information
IP and Trial Supplies	Interactive Response Technology	IRT User Acceptance Testing (UAT) Certification
IP and Trial Supplies	Interactive Response Technology	IRT User Account Management
IP and Trial Supplies	Interactive Response Technology	IRT User Manual
IP and Trial Supplies	Interactive Response Technology	IRT User Requirement Specification
IP and Trial Supplies	Interactive Response Technology	IRT Validation Certification
IP and Trial Supplies	IP Allocation Documentation	IP Treatment Allocation Documentation
IP and Trial Supplies	IP Allocation Documentation	IP Treatment Decoding Documentation
IP and Trial Supplies	IP Allocation Documentation	IP Unblinding Plan
IP and Trial Supplies	IP Documentation	IP Accountability Documentation
IP and Trial Supplies	IP Documentation	IP Certificate of Destruction
IP and Trial Supplies	IP Documentation	IP Instructions for Handling
IP and Trial Supplies	IP Documentation	IP Quality Complaint Form
IP and Trial Supplies	IP Documentation	IP Recall Documentation
IP and Trial Supplies	IP Documentation	IP Re-labeling Documentation
IP and Trial Supplies	IP Documentation	IP Retest and Expiry Documentation
IP and Trial Supplies	IP Documentation	IP Return Documentation
IP and Trial Supplies	IP Documentation	IP Sample Label
IP and Trial Supplies	IP Documentation	IP Shipment Documentation
IP and Trial Supplies	IP Documentation	IP Supply Plan
IP and Trial Supplies	IP Documentation	IP Transfer Documentation
IP and Trial Supplies	IP Release Process Documentation	Certificate of Analysis
IP and Trial Supplies	IP Release Process Documentation	IP Regulatory Release Documentation
IP and Trial Supplies	IP Release Process Documentation	IP Verification Statements
IP and Trial Supplies	IP Release Process Documentation	QP (Qualified Person) Certification
IP and Trial Supplies	Non-IP Documentation	Non-Non-IP Return Documentation
IP and Trial Supplies	Non-IP Documentation	Non-Non-IP Shipment Documentation
IP and Trial Supplies	Non-IP Documentation	Non-Non-IP Supply Plan
IP and Trial Supplies	Storage	IP Storage Condition Documentation
IP and Trial Supplies	Storage	IP Storage Condition Excursion Documentation
IP and Trial Supplies	Storage	Maintenance Logs (Device)

IRB or IEC and other Approvals

Type	Subtype	Classification
IRB or IEC and other Approvals	General	Filenote
IRB or IEC and other Approvals	General	Meeting Material
IRB or IEC and other Approvals	General	Relevant Communications
IRB or IEC and other Approvals	General	Tracking Information
IRB or IEC and other Approvals	IRB or IEC Trial Approval	IRB or IEC Approval
IRB or IEC and other Approvals	IRB or IEC Trial Approval	IRB or IEC Compliance Documentation
IRB or IEC and other Approvals	IRB or IEC Trial Approval	IRB or IEC Composition
IRB or IEC and other Approvals	IRB or IEC Trial Approval	IRB or IEC Documentation of Non-Voting Status
IRB or IEC and other Approvals	IRB or IEC Trial Approval	IRB or IEC Submission
IRB or IEC and other Approvals	Other Committees	Other Approvals
IRB or IEC and other Approvals	Other Committees	Other Submissions
IRB or IEC and other Approvals	Trial Status Reporting	IRB or IEC Notification of Trial Termination
IRB or IEC and other Approvals	Trial Status Reporting	IRB or IEC Progress Report
IRB or IEC and other Approvals	Trial Status Reporting	Notification to IRB or IEC of Safety Information

Regulatory

Type	Subtype	Classification
Regulatory	General	Filenote
Regulatory	General	Meeting Material
Regulatory	General	Relevant Communications
Regulatory	General	Tracking Information
Regulatory	Investigational Medicinal Product	Import or Export License
Regulatory	Investigational Medicinal Product	Import or Export License Application
Regulatory	Trial Approval	Notification of Regulatory Identification Number
Regulatory	Trial Approval	Public Registration
Regulatory	Trial Approval	Regulatory Approval Notification
Regulatory	Trial Approval	Regulatory Submission
Regulatory	Trial Status Reporting	Notification to Regulatory Authority of Safety or Trial Information
Regulatory	Trial Status Reporting	Regulatory Notification of Trial Termination
Regulatory	Trial Status Reporting	Regulatory Progress Report

Safety Reporting

Type	Subtype	Classification
Safety Reporting	General	Filenote
Safety Reporting	General	Meeting Material
Safety Reporting	General	Relevant Communications
Safety Reporting	General	Tracking Information
Safety Reporting	Safety Documentation	Pharmacovigilance Database Line Listing
Safety Reporting	Safety Documentation	Safety Management Plan
Safety Reporting	Trial Status Reporting	Expedited Safety Report
Safety Reporting	Trial Status Reporting	Pregnancy Report
Safety Reporting	Trial Status Reporting	SAE Report
Safety Reporting	Trial Status Reporting	Special Events of Interest

Site Management

Type	Subtype	Classification
Site Management	General	Filenote
Site Management	General	Meeting Material
Site Management	General	Relevant Communications
Site Management	General	Tracking Information
Site Management	Site Initiation	Site Evidence of Training
Site Management	Site Initiation	Site Training Material
Site Management	Site Initiation	Site Initiation Visit Report
Site Management	Site Initiation	Site Initiation Visit Confirmation Letter
Site Management	Site Initiation	Site Initiation Visit Follow Up Letter
Site Management	Site Management	Additional Monitoring Activity
Site Management	Site Management	Close-Out Visit Confirmation Letter
Site Management	Site Management	Close-Out Visit Follow Up Letter
Site Management	Site Management	Close-Out Visit Report
Site Management	Site Management	Financial Documentation
Site Management	Site Management	Monitoring Visit Confirmation Letter
Site Management	Site Management	Monitoring Visit Follow Up Letter
Site Management	Site Management	Monitoring Visit Report
Site Management	Site Management	Notification to Investigators of Safety Information
Site Management	Site Management	Protocol Deviations
Site Management	Site Management	Source Data Verification
Site Management	Site Management	Subject Eligibility Verification Forms and Worksheets
Site Management	Site Management	Subject Log
Site Management	Site Management	Visit Log
Site Management	Site Selection	Confidentiality Agreement
Site Management	Site Selection	Feasibility Documentation
Site Management	Site Selection	Pre-Study Visit Report
Site Management	Site Selection	Pre-Study Visit Confirmation Letter
Site Management	Site Selection	Pre-Study Visit Follow Up Letter
Site Management	Site Selection	Site Contact Details
Site Management	Site Selection	Sites Evaluated but not Selected
Site Management	Site Set-up	Acceptance of Investigator Brochure
Site Management	Site Set-up	Clinical Trial Agreement
Site Management	Site Set-up	Coordinating Investigator Documentation
Site Management	Site Set-up	Data Privacy Agreement
Site Management	Site Set-up	Financial Disclosure Form
Site Management	Site Set-up	Form FDA 1572
Site Management	Site Set-up	Indemnity
Site Management	Site Set-up	Investigator Regulatory Agreement
Site Management	Site Set-up	Investigators Agreement (Device)
Site Management	Site Set-up	IP Site Release Documentation
Site Management	Site Set-up	Other Curriculum Vitae
Site Management	Site Set-up	Other Financial Agreement
Site Management	Site Set-up	Principal Investigator Curriculum Vitae
Site Management	Site Set-up	Protocol Signature Page
Site Management	Site Set-up	Site Signature Sheet
Site Management	Site Set-up	Site Staff Qualification Supporting Information
Site Management	Site Set-up	Subinvestigator Curriculum Vitae

Statistics

Type	Subtype	Classification
Statistics	Analysis	Analysis QC Documentation
Statistics	Analysis	Data Definitions for Analysis Datasets
Statistics	Analysis	Final Analysis Datasets
Statistics	Analysis	Final Analysis Output
Statistics	Analysis	Final Analysis Programs
Statistics	Analysis	Final Analysis Raw Datasets
Statistics	Analysis	Interim Analysis Datasets
Statistics	Analysis	Interim Analysis Output
Statistics	Analysis	Interim Analysis Programs
Statistics	Analysis	Interim Analysis Raw Datasets
Statistics	Analysis	Subject Evaluability Criteria and Subject Classification
Statistics	General	Filenote
Statistics	General	Meeting Material
Statistics	General	Relevant Communications
Statistics	General	Tracking Information
Statistics	Randomization	End of Trial or Interim Unblinding
Statistics	Randomization	Master Randomization List
Statistics	Randomization	Randomization Plan
Statistics	Randomization	Randomization Procedure
Statistics	Randomization	Randomization Programming
Statistics	Randomization	Randomization Sign Off
Statistics	Report	Interim Statistical Report(s)
Statistics	Report	Statistical Report
Statistics	Statistics Oversight	Sample Size Calculation
Statistics	Statistics Oversight	Statistical Analysis Plan

Third Parties

Type	Subtype	Classification
Third Parties	General	Filenote
Third Parties	General	Meeting Material
Third Parties	General	Relevant Communications
Third Parties	General	Tracking Information
Third Parties	Third Party Oversight	Ongoing Third Party Oversight
Third Parties	Third Party Oversight	Qualification and Compliance
Third Parties	Third Party Oversight	Third Party Curriculum Vitae
Third Parties	Third Party Set-up	Confidentiality Agreement
Third Parties	Third Party Set-up	Contractual Agreement
Third Parties	Third Party Set-up	Vendor Selection

Trial Management

Type	Subtype	Classification
Trial Management	General	Filenote
Trial Management	General	Other Meeting Material
Trial Management	General	Relevant Communications
Trial Management	General	Tracking Information
Trial Management	Meetings	Investigators Meeting Material
Trial Management	Meetings	Kick-off Meeting Material
Trial Management	Meetings	Trial Team Evidence of Training
Trial Management	Meetings	Trial Team Training Material
Trial Management	Trial Committee	Committee Member Confidentiality Disclosure Agreement
Trial Management	Trial Committee	Committee Member Contract
Trial Management	Trial Committee	Committee Member Curriculum Vitae
Trial Management	Trial Committee	Committee Member Financial Disclosure Form
Trial Management	Trial Committee	Committee Member List
Trial Management	Trial Committee	Committee Output
Trial Management	Trial Committee	Committee Process
Trial Management	Trial Oversight	Audit Certificate
Trial Management	Trial Oversight	Communication Plan
Trial Management	Trial Oversight	Debarment Statement
Trial Management	Trial Oversight	Filenote Master List
Trial Management	Trial Oversight	Investigator Newsletter
Trial Management	Trial Oversight	List of SOPs Current During Trial
Trial Management	Trial Oversight	Medical Monitoring Plan
Trial Management	Trial Oversight	Monitoring Plan
Trial Management	Trial Oversight	Operational Oversight
Trial Management	Trial Oversight	Operational Procedure Manual
Trial Management	Trial Oversight	Publication Policy
Trial Management	Trial Oversight	Quality Plan
Trial Management	Trial Oversight	Recruitment Plan
Trial Management	Trial Oversight	Risk Management Plan
Trial Management	Trial Oversight	Roles and Responsibility Matrix
Trial Management	Trial Oversight	Transfer of Regulatory Obligations
Trial Management	Trial Oversight	Trial Management Plan
Trial Management	Trial Oversight	Trial Master File Plan
Trial Management	Trial Oversight	Trial Status Report
Trial Management	Trial Oversight	Vendor Management Plan
Trial Management	Trial Team	Trial Team Curriculum Vitae
Trial Management	Trial Team	Trial Team Details