Veeva Clinical Basics Document Types

Last updated: Jan 30, 2026

Clinical Document Autonaming

Clinical Basics automatically renames each file based on the type of document uploaded, ensuring a consistent and intuitive organizational structure.

Trial Management

Artifact #SubtypeClassificationAutoname
01.01.01Trial OversightTrial Master File PlanTrial Master File Plan
01.01.02Trial OversightTrial Management PlanTrial Management Plan
01.01.03Trial OversightQuality PlanQuality Plan
01.01.04Trial OversightList of SOPs Current During TrialList of SOPs Current During Trial
01.01.05Trial OversightOperational Procedure Manual(Product Name) - Operational Procedure Manual
01.01.06Trial OversightRecruitment PlanRecruitment Plan
01.01.07Trial OversightCommunication PlanCommunication Plan
01.01.08Trial OversightMonitoring PlanMonitoring Plan
01.01.09Trial OversightMedical Monitoring PlanMedical Monitoring Plan
01.01.10Trial OversightPublication PolicyPublication Policy
01.01.11Trial OversightDebarment StatementDebarment Statement
01.01.12Trial OversightTrial Status ReportTrial Status Report
01.01.13Trial OversightInvestigator NewsletterInvestigator Newsletter
01.01.14Trial OversightAudit CertificateAudit Certificate
01.01.15Trial OversightFilenote Master ListFilenote Master List
01.01.16Trial OversightRisk Management PlanRisk Management Plan
01.01.17Trial OversightVendor Management PlanVendor Management Plan
01.01.18Trial OversightRoles and Responsibility MatrixRoles and Responsibility Matrix
01.01.19Trial OversightTransfer of Regulatory ObligationsTransfer of Regulatory Obligations
01.01.20Trial OversightOperational OversightOperational Oversight
01.02.01Trial TeamTrial Team DetailsTrial Team Details
01.02.02Trial TeamTrial Team Curriculum Vitae(Personnel Name) - Trial Team Curriculum Vitae
01.03.01Trial CommitteeCommittee ProcessCommittee Process
01.03.02Trial CommitteeCommittee Member ListCommittee Member List
01.03.03Trial CommitteeCommittee OutputCommittee Output
01.03.04Trial CommitteeCommittee Member Curriculum Vitae(Personnel Name) - Committee Member Curriculum Vitae
01.03.05Trial CommitteeCommittee Member Financial Disclosure FormCommittee Member Financial Disclosure Form
01.03.06Trial CommitteeCommittee Member ContractCommittee Member Contract
01.03.07Trial CommitteeCommittee Member Confidentiality Disclosure AgreementCommittee Member Confidentiality Disclosure Agreement
01.04.01MeetingsKick-off Meeting MaterialKick-off Meeting Material
01.04.02MeetingsTrial Team Training MaterialTrial Team Training Material
01.04.03MeetingsInvestigators Meeting MaterialInvestigators Meeting Material
01.04.04MeetingsTrial Team Evidence of TrainingTrial Team Evidence of Training
01.05.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
01.05.02GeneralTracking InformationTracking Information - (Document Date)
01.05.03GeneralOther Meeting MaterialOther Meeting Material - (Document Date)
01.05.04GeneralFilenoteFilenote - (Document Date)

Central Trial Documents

Artifact #SubtypeClassificationAutoname
02.01.01Product and Trial DocumentationInvestigator’s Brochure(Product Name) - Investigator’s Brochure
02.01.02Product and Trial DocumentationProtocolProtocol
02.01.03Product and Trial DocumentationProtocol SynopsisProtocol Synopsis
02.01.04Product and Trial DocumentationProtocol Clarification LetterProtocol Clarification Letter
02.01.04Product and Trial DocumentationProtocol Summary of ChangesProtocol Summary of Changes
02.01.05Product and Trial DocumentationFinancial Disclosure SummaryFinancial Disclosure Summary
02.01.06Product and Trial DocumentationInsuranceInsurance
02.01.07Product and Trial DocumentationSample Case Report FormSample Case Report Form
02.01.10Product and Trial DocumentationReport of Prior InvestigationsReport of Prior Investigations
02.01.11Product and Trial DocumentationMarketed Product MaterialMarketed Product Material
02.02.01Subject DocumentationSubject DiarySubject Diary
02.02.02Subject DocumentationSubject QuestionnaireSubject Questionnaire
02.02.03Subject DocumentationInformed Consent FormInformed Consent Form
02.02.04Subject DocumentationSubject Information SheetSubject Information Sheet
02.02.05Subject DocumentationSubject Participation CardSubject Participation Card
02.02.06Subject DocumentationAdvertisements for Subject RecruitmentAdvertisements for Subject Recruitment
02.02.07Subject DocumentationOther Information Given to SubjectsOther Information Given to Subjects
02.03.01ReportsClinical Study ReportClinical Study Report
02.03.02ReportsBioanalytical ReportBioanalytical Report
02.04.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
02.04.02GeneralTracking InformationTracking Information - (Document Date)
02.04.03GeneralMeeting MaterialMeeting Material - (Document Date)
02.04.04GeneralFilenoteFilenote - (Document Date)

Regulatory

Artifact #SubtypeClassificationAutoname
03.01.01Trial ApprovalRegulatory SubmissionRegulatory Submission
03.01.02Trial ApprovalRegulatory Approval NotificationRegulatory Approval Notification
03.01.03Trial ApprovalNotification of Regulatory Identification NumberNotification of Regulatory Identification Number
03.01.04Trial ApprovalPublic RegistrationPublic Registration
03.02.01Investigational Medicinal ProductImport or Export License ApplicationImport or Export License Application
03.02.02Investigational Medicinal ProductImport or Export LicenseImport or Export License
03.03.01Trial Status ReportingNotification to Regulatory Authority of Safety or Trial InformationNotification to Regulatory Authority of Safety or Trial Information
03.03.02Trial Status ReportingRegulatory Progress ReportRegulatory Progress Report
03.03.03Trial Status ReportingRegulatory Notification of Trial TerminationRegulatory Notification of Trial Termination
03.04.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
03.04.02GeneralTracking InformationTracking Information - (Document Date)
03.04.03GeneralMeeting MaterialMeeting Material - (Document Date)
03.04.04GeneralFilenoteFilenote - (Document Date)

IRB or IEC and other Approvals

Artifact #SubtypeClassificationAutoname
04.01.01IRB or IEC Trial ApprovalIRB or IEC SubmissionIRB or IEC Submission
04.01.02IRB or IEC Trial ApprovalIRB or IEC ApprovalIRB or IEC Approval
04.01.03IRB or IEC Trial ApprovalIRB or IEC CompositionIRB or IEC Composition
04.01.04IRB or IEC Trial ApprovalIRB or IEC Documentation of Non-Voting StatusIRB or IEC Documentation of Non-Voting Status
04.01.05IRB or IEC Trial ApprovalIRB or IEC Compliance DocumentationIRB or IEC Compliance Documentation
04.02.01Other CommitteesOther SubmissionsOther Submissions
04.02.02Other CommitteesOther ApprovalsOther Approvals
04.03.01Trial Status ReportingNotification to IRB or IEC of Safety InformationNotification to IRB or IEC of Safety Information
04.03.02Trial Status ReportingIRB or IEC Progress ReportIRB or IEC Progress Report
04.03.03Trial Status ReportingIRB or IEC Notification of Trial TerminationIRB or IEC Notification of Trial Termination
04.04.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
04.04.02GeneralTracking InformationTracking Information - (Document Date)
04.04.03GeneralMeeting MaterialMeeting Material - (Document Date)
04.04.04GeneralFilenoteFilenote - (Document Date)

Site Management

Artifact #SubtypeClassificationAutoname
05.01.01Site SelectionSite Contact DetailsSite Contact Details
05.01.02Site SelectionConfidentiality Agreement(Personnel Name) - Confidentiality Agreement
05.01.03Site SelectionFeasibility DocumentationFeasibility Documentation
05.01.04Site SelectionPre-Study Visit Confirmation LetterPre-Study Visit Confirmation Letter
05.01.04Site SelectionPre-Study Visit ReportPre-Study Visit Report
05.01.05Site SelectionSites Evaluated but not SelectedSites Evaluated but not Selected
05.02.01Site Set-upAcceptance of Investigator BrochureAcceptance of Investigator Brochure
05.02.02Site Set-upProtocol Signature PageProtocol Signature Page
05.02.04Site Set-upPrincipal Investigator Curriculum Vitae(Personnel Name) - Principal Investigator Curriculum Vitae
05.02.05Site Set-upSubinvestigator Curriculum Vitae(Personnel Name) - Subinvestigator Curriculum Vitae
05.02.06Site Set-upOther Curriculum Vitae(Personnel Name) - Other Curriculum Vitae
05.02.07Site Set-upSite Staff Qualification Supporting Information(Personnel Name) - Site Staff Qualification Supporting Information
05.02.08Site Set-upForm FDA 1572(Personnel Name) - Form FDA 1572
05.02.09Site Set-upInvestigator Regulatory Agreement(Personnel Name) - Investigator Regulatory Agreement
05.02.10Site Set-upFinancial Disclosure Form(Personnel Name) - Financial Disclosure Form
05.02.11Site Set-upData Privacy Agreement(Personnel Name) - Data Privacy Agreement
05.02.12Site Set-upClinical Trial AgreementClinical Trial Agreement
05.02.13Site Set-upIndemnityIndemnity
05.02.14Site Set-upOther Financial AgreementOther Financial Agreement
05.02.17Site Set-upIP Site Release DocumentationIP Site Release Documentation
05.02.18Site Set-upSite Signature SheetSite Signature Sheet
05.02.19Site Set-upInvestigators Agreement (Device)Investigators Agreement (Device)
05.02.20Site Set-upCoordinating Investigator Documentation(Personnel Name) - Coordinating Investigator Documentation
05.03.01Site InitiationSite Initiation Visit Confirmation LetterSIV Confirmation Letter
05.03.01Site InitiationSite Initiation Visit ReportSite Initiation Visit Report
05.03.02Site InitiationSite Training MaterialSite Training Material
05.03.03Site InitiationSite Evidence of TrainingSite Evidence of Training
05.04.01Site ManagementSubject LogSubject Log
05.04.02Site ManagementSource Data VerificationSource Data Verification
05.04.03Site ManagementMonitoring Visit Confirmation LetterIMV Confirmation Letter
05.04.03Site ManagementMonitoring Visit ReportMonitoring Visit Report - (Actual End Date)
05.04.04Site ManagementVisit LogVisit Log
05.04.05Site ManagementAdditional Monitoring ActivityAdditional Monitoring Activity
05.04.06Site ManagementProtocol DeviationsProtocol Deviations
05.04.07Site ManagementFinancial DocumentationFinancial Documentation
05.04.08Site ManagementClose-Out Visit Confirmation LetterClose-Out Visit Confirmation Letter
05.04.08Site ManagementClose-Out Visit ReportClose-Out Visit Report
05.04.09Site ManagementNotification to Investigators of Safety InformationNotification to Investigators of Safety Information
05.04.12Site SelectionPre-Study Visit Follow Up LetterPre-Study Visit Follow Up Letter
05.04.12Site InitiationSite Initiation Visit Follow Up LetterSIV Follow Up Letter
05.04.12Site ManagementClose-Out Visit Follow Up LetterClose-Out Visit Follow Up Letter
05.04.12Site ManagementMonitoring Visit Follow Up LetterIMV Follow Up Letter
05.04.13Site ManagementSubject Eligibility Verification Forms and WorksheetsSubject Eligibility Verification Forms and Worksheets
05.05.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
05.05.02GeneralTracking InformationTracking Information - (Document Date)
05.05.03GeneralMeeting MaterialMeeting Material - (Document Date)
05.05.04GeneralFilenoteFilenote - (Document Date)

IP and Trial Supplies

Artifact #SubtypeClassificationAutoname
06.01.01IP DocumentationIP Supply PlanIP Supply Plan
06.01.02IP DocumentationIP Instructions for HandlingIP Instructions for Handling
06.01.03IP DocumentationIP Sample LabelIP Sample Label
06.01.04IP DocumentationIP Shipment DocumentationIP Shipment Documentation
06.01.05IP DocumentationIP Accountability DocumentationIP Accountability Documentation
06.01.06IP DocumentationIP Transfer DocumentationIP Transfer Documentation
06.01.07IP DocumentationIP Re-labeling DocumentationIP Re-labeling Documentation
06.01.08IP DocumentationIP Recall DocumentationIP Recall Documentation
06.01.09IP DocumentationIP Quality Complaint FormIP Quality Complaint Form
06.01.10IP DocumentationIP Return DocumentationIP Return Documentation
06.01.11IP DocumentationIP Certificate of DestructionIP Certificate of Destruction
06.01.12IP DocumentationIP Retest and Expiry DocumentationIP Retest and Expiry Documentation
06.02.01IP Release Process DocumentationQP (Qualified Person) CertificationQP (Qualified Person) Certification
06.02.02IP Release Process DocumentationIP Regulatory Release DocumentationIP Regulatory Release Documentation
06.02.03IP Release Process DocumentationIP Verification StatementsIP Verification Statements
06.02.04IP Release Process DocumentationCertificate of AnalysisCertificate of Analysis
06.03.01IP Allocation DocumentationIP Treatment Allocation DocumentationIP Treatment Allocation Documentation
06.03.02IP Allocation DocumentationIP Unblinding PlanIP Unblinding Plan
06.03.03IP Allocation DocumentationIP Treatment Decoding DocumentationIP Treatment Decoding Documentation
06.04.01StorageIP Storage Condition DocumentationIP Storage Condition Documentation
06.04.02StorageIP Storage Condition Excursion DocumentationIP Storage Condition Excursion Documentation
06.04.03StorageMaintenance Logs (Device)Maintenance Logs (Device)
06.05.01Non-IP DocumentationNon-Non-IP Supply PlanNon-Non-IP Supply Plan
06.05.02Non-IP DocumentationNon-Non-IP Shipment DocumentationNon-Non-IP Shipment Documentation
06.05.03Non-IP DocumentationNon-Non-IP Return DocumentationNon-Non-IP Return Documentation
06.06.01Interactive Response TechnologyIRT User Requirement SpecificationIRT User Requirement Specification
06.06.02Interactive Response TechnologyIRT Validation CertificationIRT Validation Certification
06.06.03Interactive Response TechnologyIRT User Acceptance Testing (UAT) CertificationIRT User Acceptance Testing (UAT) Certification
06.06.04Interactive Response TechnologyIRT User ManualIRT User Manual
06.06.05Interactive Response TechnologyIRT User Account ManagementIRT User Account Management
06.07.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
06.07.02GeneralTracking InformationTracking Information - (Document Date)
06.07.03GeneralMeeting MaterialMeeting Material (Document Date)
06.07.04GeneralFilenoteFilenote - (Document Date)

Safety Reporting

Artifact #SubtypeClassificationAutoname
07.01.01Safety DocumentationSafety Management PlanSafety Management Plan
07.01.02Safety DocumentationPharmacovigilance Database Line ListingPharmacovigilance Database Line Listing
07.02.01Trial Status ReportingExpedited Safety ReportExpedited Safety Report
07.02.02Trial Status ReportingSAE ReportSAE Report
07.02.03Trial Status ReportingPregnancy ReportPregnancy Report
07.02.04Trial Status ReportingSpecial Events of InterestSpecial Events of Interest
07.03.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
07.03.02GeneralTracking InformationTracking Information - (Document Date)
07.03.03GeneralMeeting MaterialMeeting Material - (Document Date)
07.03.04GeneralFilenoteFilenote - (Document Date)

Central and Local Testing

Artifact #SubtypeClassificationAutoname
08.01.01Facility DocumentationCertification or AccreditationCertification or Accreditation
08.01.02Facility DocumentationLaboratory Validation DocumentationLaboratory Validation Documentation
08.01.03Facility DocumentationLaboratory Results DocumentationLaboratory Results Documentation
08.01.04Facility DocumentationNormal RangesNormal Ranges
08.01.05Facility DocumentationManualManual
08.01.06Facility DocumentationSupply Import DocumentationSupply Import Documentation
08.01.07Facility DocumentationHead of Facility Curriculum Vitae(Personnel Name) - Head of Facility Curriculum Vitae
08.01.08Facility DocumentationStandardization MethodsStandardization Methods
08.02.01Sample DocumentationSpecimen LabelSpecimen Label
08.02.02Sample DocumentationShipment RecordsShipment Records
08.02.03Sample DocumentationSample Storage Condition LogSample Storage Condition Log
08.02.04Sample DocumentationSample Import or Export DocumentationSample Import or Export Documentation
08.02.05Sample DocumentationRecord of Retained SamplesRecord of Retained Samples
08.03.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
08.03.02GeneralTracking InformationTracking Information - (Document Date)
08.03.03GeneralMeeting MaterialMeeting Material - (Document Date)
08.03.04GeneralFilenoteFilenote - (Document Date)

Third Parties

Artifact #SubtypeClassificationAutoname
09.01.01Third Party OversightQualification and ComplianceQualification and Compliance
09.01.02Third Party OversightThird Party Curriculum Vitae(Personnel Name) - Third Party Curriculum Vitae
09.01.03Third Party OversightOngoing Third Party OversightOngoing Third Party Oversight
09.02.01Third Party Set-upConfidentiality AgreementConfidentiality Agreement
09.02.02Third Party Set-upVendor SelectionVendor Selection
09.02.03Third Party Set-upContractual AgreementContractual Agreement
09.03.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
09.03.02GeneralTracking InformationTracking Information - (Document Date)
09.03.03GeneralMeeting MaterialMeeting Material - (Document Date)
09.03.04GeneralFilenoteFilenote - (Document Date)

Data Management

Artifact #SubtypeClassificationAutoname
10.01.01Data Management OversightData Management PlanData Management Plan
10.02.01Data CaptureCRF Completion RequirementsCRF Completion Requirements
10.02.02Data CaptureAnnotated CRFAnnotated CRF
10.02.04Data CaptureDocumentation of Corrections to Entered DataDocumentation of Corrections to Entered Data
10.02.05Data CaptureFinal Subject DataFinal Subject Data
10.03.01DatabaseDatabase SpecificationsDatabase Specifications
10.03.02DatabaseEdit Check PlanEdit Check Plan
10.03.03DatabaseEdit Check ProgrammingEdit Check Programming
10.03.04DatabaseEdit Check TestingEdit Check Testing
10.03.05DatabaseApproval for Database ActivationApproval for Database Activation
10.03.06DatabaseExternal Data Transfer SpecificationsExternal Data Transfer Specifications
10.03.07DatabaseData Entry Guidelines (Paper)Data Entry Guidelines (Paper)
10.03.08DatabaseSAE ReconciliationSAE Reconciliation
10.03.09DatabaseDictionary CodingDictionary Coding
10.03.10DatabaseData QC or QA Plan and ResultsData QC or QA Plan and Results
10.03.11DatabaseDatabase Lock and Unlock ApprovalDatabase Lock and Unlock Approval
10.03.12DatabaseDatabase Change ControlDatabase Change Control
10.04.01EDC ManagementSystem Account ManagementSystem Account Management
10.04.02EDC ManagementTechnical Design DocumentTechnical Design Document
10.04.03EDC ManagementValidation DocumentsValidation Documents
10.05.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
10.05.02GeneralTracking InformationTracking Information - (Document Date)
10.05.03GeneralMeeting MaterialMeeting Material - (Document Date)
10.05.04GeneralFilenoteFilenote - (Document Date)

Statistics

Artifact #SubtypeClassificationAutoname
11.01.01Statistics OversightStatistical Analysis PlanStatistical Analysis Plan
11.01.02Statistics OversightSample Size CalculationSample Size Calculation
11.02.01RandomizationRandomization PlanRandomization Plan
11.02.02RandomizationRandomization ProcedureRandomization Procedure
11.02.03RandomizationMaster Randomization ListMaster Randomization List
11.02.04RandomizationRandomization ProgrammingRandomization Programming
11.02.05RandomizationRandomization Sign OffRandomization Sign Off
11.02.06RandomizationEnd of Trial or Interim UnblindingEnd of Trial or Interim Unblinding
11.03.01AnalysisData Definitions for Analysis DatasetsData Definitions for Analysis Datasets
11.03.02AnalysisAnalysis QC DocumentationAnalysis QC Documentation
11.03.03AnalysisInterim Analysis Raw DatasetsInterim Analysis Raw Datasets
11.03.04AnalysisInterim Analysis ProgramsInterim Analysis Programs
11.03.05AnalysisInterim Analysis DatasetsInterim Analysis Datasets
11.03.06AnalysisInterim Analysis OutputInterim Analysis Output
11.03.07AnalysisFinal Analysis Raw DatasetsFinal Analysis Raw Datasets
11.03.08AnalysisFinal Analysis ProgramsFinal Analysis Programs
11.03.09AnalysisFinal Analysis DatasetsFinal Analysis Datasets
11.03.10AnalysisFinal Analysis OutputFinal Analysis Output
11.03.11AnalysisSubject Evaluability Criteria and Subject ClassificationSubject Evaluability Criteria and Subject Classification
11.04.01ReportInterim Statistical Report(s)Interim Statistical Report(s)
11.04.02ReportStatistical ReportStatistical Report
11.05.01GeneralRelevant CommunicationsRelevant Communications - (Document Date)
11.05.02GeneralTracking InformationTracking Information - (Document Date)
11.05.03GeneralMeeting MaterialMeeting Material - (Document Date)
11.05.04GeneralFilenoteFilenote - (Document Date)