Your Easy Guide to Clinical Studies

Upon study end, study data and documents (e.g. essential documents) are archived.  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 Swiss law, 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

More

As a SP-INV:

• Familiarize yourself with legal archiving requirements (e.g. scope and duration)
• 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
  • 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 destruction procedures (e.g. documentation, data confidentiality)
• Request a certificate of destruction

 

Based on the Swiss law, the archiving period for:

• Studies with an investigational:
  • Medicinal Product (IMP) is at least 20 years
  • Medical Device (IMD) is at least 15 years

 

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
• 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)

 

The Swiss law defines the required archiving period::

• For studies with an investigational product (ClinO, Clino-MD):
  • Medicinal Product (IMP) is 20 years
  • Medical Device (IMD) is 10 years with implantable MDs being 15 years

• For HRO research projects data must be retained for at least 10 years.

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

HRO - See in particular article

• Art. 23a Data retention