Archiving of Clinical Trial Data

This SOP defines the local procedure for preparing clinical study records at an investigational site conducting a trial sponsored, co-sponsored or hosted by one or more of partner organisations – and for their subsequent transfer to archive, as required in the Regulations and the ICH GCP guidelines (E6 – as revised).

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Archiving Clinical Trial Data

All essential documents relating to a clinical study must be archived in accordance with this SOP and the requirements of the UK Regulations as follows:

Site Documentation: For at least 5 years after the completion of a clinical study, as defined by the Regulations.

Trial Master File and all Essential Documentation: For a minimum of 25 years or until at least 2 years after the last approval of a marketing application in a region where the ICH guideline applies.

and

Until there are no pending or contemplating marketing applications in a region where the ICH guideline applies

As defined in the sponsor’s protocol.

KHP-CTO has a contract with an external company that can provide an archiving service for research departments within partner organisations without archiving facilities or with unsuitable archiving facilities as assessed by the KHP-CTO. Please contact us for more information about this service.