What is it? Why is it important?

Upon study termination all essential and other relevant documents are stored or archived in order to reconstruct each single study step at some later date.

Archiving is the only available mean to verify:

In Switzerland archiving of:

  • IMP study is a minimum 10 years
  • MD study is a minimum 15 years.

More

Documents must be archived in a safe secure place. Archiving must guarantee that:

  • Documents remain legible during the entire archiving period. This includes electronically archived data. If data or documents are transferred to another medium, its transfer system must be validated
  • Only authorised personnel have access to archived study documents and material
  • All documents must be made available to EC/RA upon request
  • Removal and retrieval of archived documents are tracked and documented
  • Premises are protected against fire, humidity, and rodent infestation including access control in order to prevent theft, vandalism, forgery, destruction and loss

What do I need to do?

Familiarise yourself with legal archiving requirements.

  • Provide Site-INV with an archiving SOP that defines:
    • What documents to archive
    • Acceptable archiving premises (e.g. access protected, humidity fire and rodent protected)
    • Processes for the retrieval and return of archived documents
    • The required archiving duration including destruction procedures
  • Notify the site when the archiving period has ended, and the documents can be destroyed
  • Ask for certificate of destruction

As a Site-INV implement SOP archiving procedures provided by the SP-INV.

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

External Links

Link/Referenz zum Dokument der Ethikkommissionen über empfohlene Aufbewahrungs-/ Archivierungszeiten bei HFV-Projekten

References

ICH GCP E6(R2) – see in particular guideline

  • 5.5.6 data retention

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

  • 8.6 Documentation retention

Swiss Law

ClinO – see in particular article

  • Art.45, data retention
Abbreviations
  • CRS – Clinical Study Report
  • CTU – Clinical Trials Unit
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • Site-INV – Site Investigator
  • ISO – International Organization for Standardization
  • SOP – Standard Operating Procedures
  • SP-INV – Sponsor Investigator
Completion ↦ Management ↦ Archiving ↦ Storage
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 ↦ Management ↦ Archiving ↦ Storage

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