DAIDS Record Storage Assessment

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.

However, there may be certain situations where DAIDS may take custody of the clinical research records. For example, if a CRS is closing and unable to store the clinical research records (either in paper format or electronically) and has no other avenues even after consultation with DAIDS Office of Clinical Site Oversite (OCSO). The DAIDS RSC Record Storage Team working in consultation with DAIDS will assist institutions and/or investigators to facilitate the process of transferring clinical research records to DAIDS via the DAIDS RSC under such circumstances.

This webpage provides the following information:

  • How to determine whether clinical research records for a trial may be transferred to DAIDS for storage, including a list of trials for which DAIDS will NOT store clinical research records
  • What to do with clinical research records that cannot be transferred to DAIDS
  • Instructions on how to complete the clinical research record transfer process if DAIDS will accept clinical research records for storage

How to Determine Whether a CRS’s Clinical Research Records Can Be Transferred to DAIDS for Storage

Only under certain circumstances can a CRS transfer its clinical research records to DAIDS for storage. To determine if your CRS’s circumstances warrant a transfer of clinical research records to DAIDS via the DAIDS RSC for storage, please contact your DAIDS OCSO Program Officer to discuss.  As part of this discussion, please review the Trial List below which includes DAIDS-sponsored or -supported trials that do not qualify for document storage by DAIDS. This list is maintained by the DAIDS RSC Record Storage Team under the guidance of DAIDS. Trials included on the list have been determined to meet record retention requirements referenced in the Storage and Retention of Clinical Research Records Policy.

  • If your trial IS included on the list, then DAIDS will NOT accept the trial’s clinical research records for storage. Please follow local regulations and institutional policies regarding record retention requirements. Refer to the "What Should be Done with Clinical Research Records that CANNOT be Sent to DAIDS" section below.
  • If your trial IS NOT included on the list, please follow the "Steps for Transferring Clinical Research Records to DAIDS for Storage" section below.

List of trials for which clinical research records will NOT be stored by DAIDS

Next, if it has been determined that the circumstance at your CRS warrants transfer of a trial’s clinical research records to DAIDS via the DAIDS RSC, please contact your CRS’s DAIDS OCSO Program Officer to discuss.

What Should be Done with Clinical Research Records that CANNOT be Sent to DAIDS?

For trials that are included on the “List of trials for which clinical research records will not be stored by DAIDS”, research institutions and/or investigators must follow local, national regulations and institutional policies before proceeding with any clinical research record destruction. When more than one requirement applies, the most stringent retention requirement must be followed. Please consult with the institution affiliated with the CRS and the CRS’s local IRB/EC prior to the destruction of any clinical research records. Neither DAIDS nor the DAIDS RSC will give permission to destroy any clinical research records.

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

Steps for Transferring Clinical Research Records to DAIDS for Storage

Below are the steps you will need to take to obtain DAIDS’ approval to transfer your clinical research records and how to transfer them:

  1. If your trial is NOT included in the trial list above and your DAIDS OCSO PO has determined that your site’s circumstance warrants a transfer of clinical research records, please contact the DAIDS RSC Record Storage Team 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. The determination of which clinical research records are eligible will be made on a trial-by-trial basis by DAIDS.
  2. Request authorization to ship your clinical research records by emailing the DAIDS RSC Record Storage Team.
    Per the instruction document below, the Principal Investigator/Investigator of Record (IoR) 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:

Please send any questions regarding clinical research records storage to the DAIDS Record Storage Team.

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