DAIDS Storage and Retention of Clinical Research Records

The DAIDS Storage and Retention of Clinical Research Records Policy states:

For those clinical research records that are the property of the awardee institution, the institution is responsible for maintaining and retaining clinical research records in accordance with all applicable regulations, policies, and guidelines.

The goal of this webpage is to communicate updates and guidance on clinical research record storage for those performing DAIDS-sponsored or supported clinical research (hereafter referred to as “trials”). The following information is provided on this webpage:

  • A listing of trials which have met DAIDS record retention requirements;
  • Guidance for Clinical Research Site (CRS)/pharmacy/laboratory staff if an entity is no longer able to store its clinical research records, including how to request transfer of clinical research records to DAIDS for review on a case-by-case basis.

Please refer to the linked Memo from the DAIDS Regulatory Affairs Branch (RAB), dated May 07, 2025, which relates to information on this webpage.

Trials which have met DAIDS Record Retention Requirements

The DAIDS Regulatory Support Center (RSC), in collaboration with, and per guidance from, the DAIDS Regulatory Affairs Branch (RAB), maintains a Trial List which outlines the trials that have met DAIDS record retention requirements according to the DAIDS Storage and Retention of Clinical Research Records Policy.

The Trial List is updated annually and can be found at the following link:

For trials on the Trial List, research institution staff and/or investigators of record must follow institutional policies and/or local requirements and/or national regulations related to storage of clinical research records before proceeding with any record destruction. When more than one clinical research record retention requirement applies, the most stringent requirement must be followed.

Please consult with the institution affiliated with the CRS/pharmacy/laboratory and the CRS’ local Institutional Review Board (IRB)/Ethics Committee (EC) prior to the destruction of any clinical research records. DAIDS will not give permission to destroy any clinical research records.

Case-by-Case Situations for Transferring Clinical Research Records to DAIDS: How to Determine if a Trial’s Clinical Research Records can be Transferred to DAIDS for Storage

There may be certain situations that require DAIDS to take custody of clinical research records, and such requests must be reviewed by DAIDS for determination on a case-by-case basis. To determine if your CRS/pharmacy/laboratory’s trial meets the requirements for transfer of select clinical research records to DAIDS for storage, please consult with your CRS’ DAIDS Office of Clinical Site Oversight (OCSO) Program Officer (PO) and review the Trial List.

Management of Clinical Research Records that CANNOT be Transferred to DAIDS

  • Clinical research records from trials that are included on the Trial List will not be accepted by DAIDS for storage.
  • Consult with the institution affiliated with the CRS/pharmacy/laboratory and the CRS’ local Institutional Review Board (IRB)/Ethics Committee (EC) prior to the destruction of any clinical research records.
  • DAIDS will not give permission to destroy any clinical research records.

Steps for Determining which Clinical Research Records can be Transferred to DAIDS for Storage

If it has been determined that the circumstances at your CRS/pharmacy/laboratory warrant transfer of a trial’s clinical research records to DAIDS, consult with your CRS’ DAIDS OCSO Program Officer (PO), and follow these steps:

  1. Contact the DAIDS RSC via email at rst@tech-res.com regarding which clinical research records for a trial may be shipped to the DAIDS RSC for storage on behalf of DAIDS. Please note that not all clinical research records for a trial will be eligible for transfer to DAIDS. The determination of which clinical research records are eligible for transfer will be made by DAIDS.
  2. Request authorization to ship your clinical research records by emailing the DAIDS RSC at rst@tech-res.com. Per the Instructions for Authorization, the Principal Investigator/Investigator of Record (IoR), CRS Coordinator, Pharmacists, or designee, is responsible for submitting the request for authorization to transfer clinical research records to DAIDS via the DAIDS RSC.
  3. Pack and ship your clinical research records following these instructions:

For additional information, visit the Clinical Research Records Storage FAQs.

Please send any questions regarding clinical research records storage to rst@tech-res.com.

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