What is it? Why is it important?

Upon study termination, all essential and other relevant documents are archived. The archive must be set-up in a manner that enables the study to be reproducible at any time during the archiving period.

Archiving processes and premises should be in place to:

  • Prevent document destruction before the end of the required archiving period (e.g. fire-, humidity-, rodent infestation)
  • Ensure premises are access restricted and protected against unlawful access, modification, theft, vandalism and forgery
  • Ensure that any removal and retrieval of archived documents is documented and logged
  • Allow access and retrieval of documents, should this become necessary (EC/RA audit or inspection)

Archiving requirements including the required archiving period are defined in the law.

More

After study termination, it is required that a study IMP/IMD be retained until the expiry date of the last IMP batch supplied, or the last series of devices used in the study, but at least for:

  • 10 years for IMP and IMD studies
  • 15 years for studies with implantable devices
  • Or otherwise specified in the study protocol

Documents required for the identification and follow-up of study participants, including all other original data must be archived for at least:

  • 10 years for IMP and IMD studies
  • 15 years for studies with implantable devices
  • Or otherwise specified in the study protocol

What do I need to do?

As a SP-INV define and document archiving processes in an SOP.

As a SP-INV or Site-INV:

  • Know which documents to archive (check ICH-GCP chapter 8)
  • Know the required archiving period applicable to your study
  • Create an archiving index with an overview of filed documents
  • Store documents in a manner that guarantees legibility over time (electronic and hard copy)
  • Ensure to use validated transfer systems when making copies or transferring data to another storage medium (e.g. certified copies of SD)
  • Designate a staff member responsible to oversee archiving premises, including the correct implementation of the archiving SOP

Study documents are archived over many years, which might generate archiving costs. Consequently, when planning your study budget, remember to include archiving costs.

More

As a Site-INV:

  • Follow SOP archiving procedures as provided by the SP-INV, or according to an approved site specific SOP (e.g. binders are clearly labelled with study name, responsible SP-INV, study site, length of archiving)
  • Keep a record of archived documents in order to request their destruction at the end of the archiving period. The request and its approval is granted by the SP-INV

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

  • 4.9.5 Data Retention
  • 8 Essential Documents for the Conduct of a Clinical Trial

Swiss Law

ClinO – see in particular article

  • Art. 45 Data retention requirements

ClinO-MD – see in particular

  • Art. 40 Document retention requirements
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • ICH-GCP – International Council for Harmonisation – Good Clinical Practice
  • IMP – Investigational Medicinal Product
  • IMD – Investigational Medical Device
  • SD – Source Document
  • Site-INV – Site Investigator
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor Investigator
Completion ↦ Documents ↦ Required Documents ↦ Doument Archiving
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 ↦ Documents ↦ Required Documents ↦ Doument Archiving

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