Your Easy Guide to Clinical Studies

Upon study end, study data and documents (e.g. essential documents) are file and archived in the TMF/ISF.  The aim is to retain the ability to reconstruct the study at some later date.

 

Archiving is the only available mean to verify that the:

• Information in the Clinical Study Report and its publications are correct
• The study team did comply with ethics requirements, the applicable law (e.g. Swiss law, international), and applicable guidelines (e.g. ICH GCP, ISO 14155, ISO 20916)

 

Regardless whether documents are available as hard copies or in an electronic form, they must:

• Remain legible during the entire archiving period
• Be made available to the Ethics Committee (EC) and Swissmedic upon request
• Be traceable in the event they become removed and returned from/to the archive
• Be validated when subjected to a transfer medium (e.g. certified copies)

 

Archiving premises must be:

• Access restricted to prevent theft, destruction, or forgery (e.g. access with personalised badge or key)
• Protected against fire, humidity, and rodent infestation

As a SP-INV:

• Familiarize yourself with legal archiving requirements (e.g. scope and duration)
• Archive the study documentation on behalf of your role as the Sponsor (TMF)
• Provide the Site-INV(s) with an archiving SOP, including instructions on:
  • Documents / data to be archived (e.g. ICF, participant-identification-log)
  • Acceptable archiving premises
  • Procedures for the retrieval and return of archived documents and data
  • Required duration of archiving
• Notify the Site-INV(s) when study records are no longer needed. Include destruction procedures (e.g. documentation, data confidentiality)
• Request a certificate of destruction

 

As a Site-INV:

• Implement the archiving SOP of the SP-INV
• As agreed, return selected data and documents to be archived with the SP-INV
• If applicable, remind the SP-INV when the archiving duration is over
• Follow required destruction procedures (e.g. documentation on how, when, and where documents were destroyed)

References

ICH GCP E6(R2) – see in particular  guideline

• 5.5.6 Data retention

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

• 8.6 Document retention

ISO 20916:2049 In vitro diagnostic medical devices

Swiss Law

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