Archiving of Clinical Trial Data

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:

and or

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 (5.7MB)


Related Documentation

Clinical Trial Archive Document (.doc 874KB)

Archiving Process Map (.doc 874KB)

Document Retrieval Process Map (.doc 873Kb)