What is it? Why is it important?

Essential Documents are all those documents which individually and collectively permit the full reconstruction of the study by evaluating:

In order to allow for the above criteria, all essential documents generated during study conduct need to be retained and filed on an ongoing basis.

NOTE: “What has not been documented is considered not done!

More

Essential document(s):

  • Are filed in the ISF by the Site-INV and in the TMF by the SP-INV
  • Are filed in a timely manner starting at the beginning of a study until study closure by both Site-INV and SP-INV
  • Are archived over a predefined period of time after study completion
  • Are reviewed by the monitor during the monitoring of the study
  • Are reviewed by RA during an inspection.

What do I need to do?

File all essential documents generated during study conduct in applicable files (TMF and/or ISF), which includes amongst others the:

  • Investigator’s brochure and updates thereof
  • The study protocol, PIS, ICF, and amendments thereof
  • EC/RA approval(s), updates and communication
  • Ongoing staff qualification and training records
  • Laboratory maintenance, certification of analysis
  • IMP/MD and material management
  • Monitoring visits performed during study conduct, including applicable audits or inspections
  • Communication between Site-INV and SP-INV, and other relevant partners
  • Annual safety reports

For more information refer to Documents in this Study Guide.

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

  • 8.0 Essential documents for the conduct of a clinical trial

ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)

  • Annex E - Essential clinical investigation documents
Abbreviations
  • CTU – Clinical Trials Unit
  • EC/RA - Ethics Committee / Regulatory Authorities
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • ICF – Informed Consent Form
  • IMP/MD – Investigational Site File / Medical Device
  • ISO – International Organization for Standardization
  • ISF – Investigator Site File
  • PIS – Patient Information Sheet
  • RA – Regulatory Authorities
  • Site-INV – Site-Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Essential Documents
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): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Essential Documents

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