Clinical Research Records Storage Frequently Asked Questions

How long must the clinical research site maintain clinical research records?

Clinical research record retention requirements are to be determined on a trial-by-trial basis, taking into consideration:  local, national regulations; NIH, NIAID, and DAIDS policies; and all applicable guidelines.  When more than one requirement applies, the most stringent retention requirement must be followed.

The clinical research records are the property of the research institution. Below please find a link to the DAIDS policy on clinical research record retention.

How do I confirm if clinical research records can be destroyed?

The clinical research site must confirm with their institution and their local IRB/EC whether the clinical research records from the trials listed on the DAIDS Record Storage Assessment page called "List of trials for which clinical research records will NOT be stored by DAIDS" may be destroyed. DAIDS and the DAIDS RSC will not give permission to destroy clinical research records.

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