How long must the Clinical Research Site (CRS) maintain clinical research records?
Clinical research record retention requirements are determined on a trial-by-trial basis, taking into consideration institutional policies and/or local requirements and/or national regulations (see Storage and Retention of Clinical Research Records Policy for relevant guidelines/policies).
When more than one clinical research record retention requirement applies, the most stringent requirement must be followed. See the Trial List for the list of trials that have met DAIDS’ record retention requirements.
The clinical research records are the property of the research institution.
How do I confirm if clinical research records can be destroyed?
The Investigator of Record/designated CRS staff must review the Trial List on the DAIDS Record Storage Assessment webpage to determine if DAIDS’ record retention requirements have been met. If DAIDS’ record retention requirements have been met, they should confirm with their institution, applicable Network Manual of Operations, their local Institutional Review Board/Ethics Committee (IRB/EC), and any other applicable regulations, whether the clinical research records may be destroyed. DAIDS will not give permission to destroy any clinical research records. That determination must be made by the institution, considering the Trial List, protocol, institutional policies and/or local requirements and/or national regulations.
How often is the Trial List updated by DAIDS?
The Trial List (List of trials that have met DAIDS record retention requirements) is updated by DAIDS annually.
What documentation is required at the site following destruction of clinical research records?
The institution affiliated with the CRS, as well as the IRB/EC, should be consulted for guidance regarding what documentation is required to document destruction of clinical research records. DAIDS recommends keeping records of the decision(s) made, who made them, and when they were made.
Our CRS staff reviewed the Trial List and have additional record retention questions. Who should we contact?
Please send any questions regarding retention and storage of clinical research records to the DAIDS Record Storage Team and copy your DAIDS OCSO Program Officer.
Does DAIDS have guidelines in place for digitization of clinical research records for long-term storage?
Yes, guidelines for digitization of clinical research records for long-term storage are available in Electronic Storage of Human Research Study Documents for DAIDS Sponsored Research – Digitization of Research Records. Please contact your DAIDS OCSO or Network Program Officer to discuss recommendations for this process.
Our CRS is closing permanently and making arrangements for offsite storage. Does DAIDS have guidance addressing this topic?
The Investigator of Record (IoR) or designee is responsible for identifying an appropriate offsite location to store records, if necessary. The IoR or designee will be the point of contact for future DAIDS or Network queries regarding the clinical research records. CRS staff should notify the DAIDS OCSO Program Officer affiliated with the site of any changes in long-term storage arrangements.
Our CRS is closing permanently, and we have no capability/capacity for long-term storage of clinical research records for our trials. Can we transfer clinical research records to DAIDS?
Contact your DAIDS OCSO Program Officer to discuss CRS closure logistics and limitations for long-term record storage. DAIDS may decide to take custody of the clinical research records for a given trial. DAIDS will work with you to determine if your CRS/pharmacy/laboratory’s clinical research records are eligible for transfer to DAIDS for storage.