Your Easy Guide to Clinical Studies

Upon study termination, all essential and other relevant documents (e.g. quality documents such as SOPs, WIs, study processes) 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 (e.g. EC, RA (e.g. Swissmedic) audit or inspection)

 

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

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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 Soure Data (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.

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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