When all study activity is complete at a site, the study must be closed. Occasionally studies may be closed for negative reasons which include negative safety or efficacy data, insufficient enrollment or compliance issues at a site.
For industry sponsored trials, there will be an official close-out visit. Everything must be complete at this time; no changes or corrections are allowed once the study is closed. The sponsor’s monitor will do a final evaluation of CRFs, drug accountability and the regulatory files.
All studies require a final progress report be submitted to the IRB through the eIRB system.
Record retention requirements are covered in the protocol and contract for an industry sponsor. Records need to be stored for varying amounts of time and there must be an easily accessible record of where records are being stored. Six years is the Duke requirement for archiving of research records, but no records should ever be destroyed without the sponsor’s written approval.
Duke has a record retention warehouse. The warehouse staff will supply specific boxes and the form for identifying the records being stored and who may access these records. There may be a document storage fee. To request forms, boxes or information contact General Service Support Facility, Record Retention System, 1408 A Christian Avenue, Durham NC 27701 or 919-383-3313.
Research records include, by way of example but not limitation, material contained in research notes, laboratory notebooks and in other media and instrument printouts. Significant research materials or products generated by any research are also part of the record and should be retained and available. Archived research records should be the original documentation and not copies.