What is it? Why is it important?

Filing of study documents is important as they:

  • Individually and collectively allow for the evaluation of study conduct
  • Ensure ongoing important oversight and successful study management

Essential study documents are filed by the:

  • SP-INV in a Trial Master File (TMF)
  • Site-INV in an Investigator Site File (ISF)

TMF/ISF files:

  • Provide a structured filing system as depicted in ICH-GCP (Chapter 8)
  • The ongoing filing of study documents during study conduct
  • Allows for easy retrieval
  • Are an important source used during audits or inspections by RA (e.g. Swissmedic)

Documents are filed either electronically or in paper format. For electronic paper-copies, ensure to follow certified copying procedures.

Documents that have original wet-ink signatures (e.g. ICF, various logs, CVs) are, in addition to a potential electronic copy, retained in their original form.

What do I need to do?

As a SP-INV or Site-INV file documents:

  • Prior-, during- and after the completion of your study
  • As applicable, in the study TMF and/or ISF
  • According to ICH-GCP guidelines
  • Based on restricted access (e.g. available only to study staff who needs them for the execution of given study tasks)
  • In a manner that prevents accidental or premature loss or destruction
  • In a timely manner in order to ensure the DMS of the study remains current

For the most part essential documents are filed both by the SP-INV in the TMF and the Site-INV in the ISF. Still, there are exceptions where documents are only filed in the ISF, as they must never be made available to the SP-INV of the study (e.g. participant identification-log).

More

Based on data protections laws, any information that permit the identification of study participants must exclusively remain available to the study site. Example of such documents are:

  • Signed Informed Consent Forms (include participant name and date of birth)
  • Subject Identification-Log (matches subject name with study ID in the study CDMS)
  • Subject Enrolment Log (lists name of all participants enrolled in the study)
  • Source documents that include participant identifiers (e.g. participant name, address, date of birth)

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 8 Essential Documents for the Conduct of a Clinical Trial
Abbreviations
  • CDMS – Clinical Data Management System
  • CTU – Clinical Trials Unit
  • CV – Curriculum Vitae
  • DMS – Document Management System
  • EC – Ethics Committee
  • ID - Identification
  • ICF – Informed Consent Form
  • ISF – Investigator Site File
  • RA – Regulatory Authorities
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
  • TMF – Trial Master File
Basic ↦ Documents ↦ Document Management ↦ Document Filing
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Basic ↦ Documents ↦ Document Management ↦ Document Filing

Please note: the Easy-GCS tool is currently under construction.