The purpose of this SOP is to define the local procedure for preparing clinical study records at an investigational site conducting a trial sponsored, co-sponsored or hosted by one of more of the Partner Organisations - and for their subsequent transfer to archive, as required in the Regulations and the ICH GCP guidelines (E6 - as revised).
All essential documents relating to the clinical study must be archived in accordance with this KHP CTO 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.
Until there are no pending or contemplating marketing applications in a region where the ICH guideline applies
As defined in the sponsor’s protocol.
The KHPCTO has a contract with an external company that can provide an archiving service for research departments within the Partner Organisations that have no archive facilities of their own or have unsuitable archiving facilities as assessed by the KHPCTO.
SOP: Archiving of Clinical Trial Data & Essential documentation (261KB)
Clinical Trial Archive Document (.doc 874KB)
Archiving Process Map (.doc 874KB)
Document Retrieval Process Map (.doc 873Kb)
