18. Is there a need for an Archivist?
It is a legal requirement that the sponsor appoints a named individual within the organisation to be responsible for archiving the documents which are, or have been, contained in the TMF and that access to these documents shall be restricted to those appointed individuals and auditors or inspectors (SI 2004/1031 [as amended] 31A, (9)). There can be more than one such person named and the requirement can be met by either having specific archivist role(s) or person(s) in another role may also have the specific archiving duties, but either way there should be clear documentation to support the appointment(s) and appropriate training provided. The named individual responsible must have a clear legal link to the sponsor, in that they are the sponsor/co-sponsor themselves or employed or contracted by the sponsor/co-sponsor (SI 2004/1031 [as amended] 31A, (11)). Whilst an investigator site institution is not required to have a named individual (unless they are a sponsor in their own right), where the organisation has many trials, a person responsible for this activity would be recommended.
Version 1: 17th December 2012
