Your Easy Guide to Clinical Studies

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

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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.

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