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).
Archiving Clinical Trial Data and Essential Records
All essential documents relating to a clinical study must be archived in accordance with this SOP and the requirements of the UK Clinical Trial Regulations as follows:
- Site Documentation: For at least 25 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 after the completion of the study as defined by the Regulations or longer if required for marketing authorisation purposes.
or
- 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.