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Research documents that are considered essential for archiving are those required for the Study/Trial Master File(S/TMF), Investigator Site Files (ISFs) and completed Case Report Forms (CRFs) as listed in the ICH Document E6. The storage facilities utilised for archive must be GCP compliant (i.e. secure (authorised personnel access only) and environmental hazard proof (infestations/asbestos/humidity/flood/fire etc)).

Plans and procedures for archiving should be considered early on in the design stage, any cost implications considered in the funding application) and retention times detailed in the protocol. The specific archive requirements for a study will be assessed by Noclor as part of the sponsorship request process.

Where research involves NHS patients, the case notes for research participants (paper or electronic) should also be retained for the same period as the essential documents (as a minimum) following the end of the study. It is the responsibility of the Principal Investigator to ensure that all patient case notes are appropriately labelled to ensure retention (they should work to local Trust policies on how records should be flagged for the required period of time).

Responsibilities for archiving essential documents

For research sponsored by a Noclor partner, essential documents (S/TMF and ISF/CRFs for sponsor (lead) investigator site) should be archived using the commercial archive services (Iron Mountain) in accordance with Noclor Archive SOP.

For clinical trials sponsored by a Noclor partner, the Chief Investigator will be required to sign to acknowledge that they have read and understood the Noclor Archive SOP prior to study activation.

The Chief Investigator is responsible for preparing essential documentation for archive; ensuring that all documentation is present and correct, boxed and indexed and labelled with unique identifier code (for iron mountain services this will be a barcode).

Noclor have a designated archivist, the Head of R&D, who oversees archive of essential documentation of research sponsored by a Noclor partner.

Archive at investigator sites

Archiving is required for the Investigator Site File (including CRFs and incorporating any Pharmacy File). Responsibilities for archiving site-specific study documents lies with the host organisation (as delegated through signed agreements).

Host sites are encouraged to archive to the same standards as those applied to sponsor archive.

Archiving requirements should be detailed in the protocol and responsibilities clearly defined at site initiation. The Principal Investigator should be reminded of the responsibilities at the close out/in the end of study notification communication.

In accordance with ICH E6 (Section 4.9.5), Noclor (on behalf of sponsor) will inform/instruct the Principal Investigator/host organisation as to when the documents no longer need to be retained (i.e can be destroyed).

Retrieval & destruction

Noclor’s designated archivist is responsible for maintaining an archive tracking system which logs all archived essential documentation for research sponsored by a Noclor partner and flags the date that documents are no longer required to be retained (destruction date).

Retrieval of essential documentation will be co-ordinated by the designated archivist in order to maintain tracking records of retrieval/ replacement. It is important to note that the way documentation is prepared for archive (i.e indexed) should be appropriate to the level of retrieval anticipated (it can be costly financially to retrieve large volumes of documentation at short notice because it is not known where a particular file is located due to poor indexing).

At the point that documents have reached the end of their retention period (unless otherwise notified by the Chief Investigator), the designated archivist will authorise the destruction of essential documents and notify sites/investigator in writing where appropriate. The records of destruction should be retained electronically (for a minimum of 5 years).