What is it? Why is it important?

In a study strict document management requirements exist.

All information collected and applied in a study must be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

Study essential documents enable operational staff, monitors, auditors and inspectors to evaluate compliance with the study protocol, the safe conduct of the study, and the quality of obtained data.

GCP chapter 8 and ISO Annex E provide an overview of documents to be collected prior-, during-, and upon study completion.

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  • Essential documents play a key role in successful study management, and provide written evidence that the study was conducted in compliance with GCP
  • Upon study termination essential documents must be archived during a pre-determined number of years.
  • The study can be audited or inspected at any time by the EC or RA.

What do I need to do?

Implement a document filing system based on the following filing systems:

  • The TMF: Files documents and activities performed by the SP-INV and the trial site(s).
  • The ISF: Files documents and activities performed at a particular study site. Information on participant identification is exclusively filed in the ISF and remains at the site.

Document filing should at any time be accurate and current.

For more information refer to Documents in this Study Guide.

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Extent of documents collected and filed depends on:

  • Study type (e.g. clinical (ClinO), non-clinical (HRO))
  • Risk category (e.g. category A, B or C). A higher risk category usually requires more extensive documentation
  • Mono- versus multicentre studies
  • Study complexity (e.g. study design, numbers of participants included, study duration)

A successful document management system, whether electronic or paper-based, requires ongoing oversight and maintenance.

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 guidelines

  • 8. Essential documents for the conduct of a clinical trial
  • 4.9.4 Retention of study documents
  • 4.9.5 Document archiving
  • 5.5.6-7-8 Archiving of SP-INV documents

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

  • Annex E Essential clinical investigational documents
  • 7.5 Clinical investigational documents and documentation
  • 7.8 Document and data control
  • 8.6 Document retention
Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • EC – Ethics Committee
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • HRO - Human Research Ordinance
  • ISF – Investigator Site File
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Set-Up ↦ Management ↦ Document Management ↦ Requirements
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): Set-Up ↦ Management ↦ Document Management ↦ Requirements

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