What is it? Why is it important?

Upon study end, all study data, essential documents and other relevant documentation are archived. This is necessary for each single study step to be reconstructed at some later date.

Archiving must guarantee that:

  • Documents are in a safe and access restricted location, protected against fire, humidity and rodent infestation
  • Only authorized personnel retain access to archived study documents
  • The removal and retrieval of archived documents are tracked (e.g. when, what, and who retrieved/returned documents)
  • Documents remain legible during the entire archiving period. This includes also electronically archived data
  • In the event that data and documents are transferred to another medium, its transfer system is validated (e.g. scanning of paper documents into an electronic filing system)
  • If applicable and upon request, all documents are accessible and made available to EC/RA

More

Archiving is the only available way to verify that the:

  • Information in the clinical (final) study report and its publications are correct
  • SP-INV, Site-INV, and monitor complied with ICH GCP and applicable laws

What do I need to do?

As a SP-INV:

  • Familiarize yourself with legal archiving requirements
  • Provide the Site-INV(s) with an archiving SOP, including instructions on:
    • Documents / data to be archived (e.g. ISF, participant-identification-log)
    • Acceptable archiving premises (e.g. access protected, humidity control)
    • Procedures for the retrieval and return of archived documents and data
    • Expected duration of archiving
  • Notify the Site-INV(s) when study records are no longer needed. Include procedures for document destruction (e.g. documentation, data confidentiality)
  • Request a certificate of destruction

As a site-INV:

  • Implement archiving measures that ensure adequate storage conditions for study documents and its data. In particular prevent their accidental or premature destruction (e.g. in compliance with SP-INV SOP)
  • Remind the SP-INV when the archiving duration is over, and follow required destruction procedures (e.g. documentation on how, when, and where documents were destroyed)

For more information refer to QM & Risks and Data Handling in this Study Guide.

Where can I get help?

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

References

ISO 14155:2020 Medical devices (access liable to costs) – see in particular section and annex

  • 8.6 Document retention
  • Annex E Essential clinical investigation documents

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD

ClinO – see in particular articles

  • Art. 18 Storage of Health-Related Personal Data and Biological Material
  • Art. 45 Data retention requirements

ClinO-MD – see in particular article

  • Art. 40 Document retention requirements
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX - Publication Platform for Federal Law
  • ICH GCP – International Council for Harmonisation Good Clinical Practices
  • ISO – International Organization for Standardization
  • ISF – Investigator Site File
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
Completion ↦ Ethics and Laws ↦ Archiving ↦ 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): Completion ↦ Ethics and Laws ↦ Archiving ↦ Requirements

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