Archiving documents in Clinical Trials Scenario

Clinical trial documentation can be archived by the Principal investigator /designee or the Sponsor. The Principal Investigator must agree with the sponsor the exact requirements for local archiving and make or assist in making the necessary arrangements. The investigator has a responsibility to allow the sponsor and regulators access to the archived data on request. The Management of trial documentation and study file is the responsibility of the Principal Investigator however this role may be delegated to the clinical trials co-ordinator or research nurse or other member of the research team. This procedure should be carried out in accordance with local hospital policies. All data should be made available if requested by relevant authorities. The Trust Archivist will consolidate the research files and manage the clinical trials archives store. For local studies not involving investigational medicinal products it will be the responsibility of the Principal Investigator to
store the data.

Archiving occurs as soon as possible after completion of a study, typically the end of the follow-up stage for treatment and multicentre studies, and at close down of study for all other studies. Regulations state that the documentation for clinical trials involving medicinal products should be archived for at least five years after the last licence application. Patients’ medical records should be retained for a minimum of twenty years after the completion of a trial. Three years following the Principal Investigator’s close down of the study the archivist will gather all of the trial documents from all the areas across the Trust, including Pharmacy, and undertake the consolidation process.