Your Easy Guide to Clinical Studies

Upon study termination all essential and other relevant quality documents are archived. This is essential in order to reconstruct the study at some later date.

 

To retain access to archived documents is the only reliable mean to verify that:

• The information and results described in the Clinical Study Report (CSR) and applicable publications are correct
• The SP-INV, Site-INV, including relevant study staff did conduct the study in compliance with the EC approved study protocol, ICH GCP, applicable regulatory requirements (e.g. Swissmedic, FOPH, international), and the law (e.g. Swiss law)

 

In Switzerland the required archiving period depends on study type. Studies with:

• Investigational Medicinal Products (IMP) have a minimum archiving period of 10 years (e.g. ClinO)
• Investigational Medical Devices (IMD) have a minimum archiving period of 15 years (e.g. ClinO-MD)
• Transplantation into humans have a minimum archiving period of 20 years (e.g. Transplantation Act)

 

A a SP-INV:

• Ensure appropriate archiving facilities for both short and long-term archiving
• Make a list of documents to be archived. Establish an archiving index for ease of retrieval at some later date
• Define documents that must remain archived at participating study sites (e.g. participant identification logs)
• Write an archiving SOP
• Ensure study sites comply with the SOP and the required archiving period
• Notify the study site when records are no longer needed. Include required destruction procedures (e.g. destruction certificate)

 

As a SP-INV and Site-INV ensure that during the entire archiving period:

• Documents (electronic and hard/paper copies) remain legible.
• Document transfers to another medium are validated (e.g. certified copies)
• Only authorised personnel retain access to the archive 
• The removal and retrieval of archived documents is recorded
• Premises are protected against fire, humidity and rodent infestation

 

In the event of an audit or inspection ensure archived documents are made readily available upon request.

 

For more information refer to Documents in this Study Guide.

References

ICH GCP E6(R2) – see in particular guidelines

• 5.5 Trial management, data handling, and record keeping
• 5.5.6 Data retention

ISO 9001 (access liable to costs) - see in particular 

• Annex A6 Documented information  

 

Swiss Law

HRO – see in particular article

• Art. 5 Storage of data and biological material

ClinO – see in particular article

• Art.45 Data retention

ClinO-MD - see in particular

• Art. 40 Data retention requirements

Transpantation Act - see in particular article

• Art. 35 Mandatory archiving