TMF and essential documents
Keep the evidence of study conduct complete.
Define how essential records will be collected, reviewed, reconciled and handed over throughout the study.
Planned · availability unverifiedDiscuss your study
Plan the document responsibilities
Agree which records belong with the sponsor, institution and service provider, and who creates, reviews and retains each one. Set naming, versioning and access conventions that keep documents understandable and retrievable.
Scope essential-document support
Identify the expected deliverables and the platform or filing location before work starts.
- Study-specific document lists and filing plans
- Collection and review of essential documents
- Version and signature checks
- Completeness and outstanding-item tracking
- Reconciliation across agreed document locations
- Close-out indexes and handover records
Protect access and traceability
Distinguish original records, copies and any required certified copies. Restrict access to authorized people and preserve the context of corrections. Record the location of source documents so authorized reviewers can access them without inappropriate disclosure.
Agree retention before close-out
NHRC 2022 section 3.5 describes retaining study-related documents for at least five years after the study ends, and longer when applicable requirements or the sponsor agreement require it. Establish the actual retention schedule, record custodian, storage location, access and change-notification route. This service area concerns document work, not a claim that the website supplies a validated eTMF or CTMS.
Common questions
Clarify the scope.
How is the scope agreed?
Begin with the protocol and required deliverables, then confirm the team, responsibilities, dependencies and acceptance criteria in writing. Service availability must be confirmed before commitment.
Can approval, recruitment or delivery dates be guaranteed?
No. Authority decisions, site capacity and study circumstances determine the schedule. Planning should identify assumptions and dependencies rather than promise an outcome.
Sources and further reading
Additional Resource
Related pages
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