Case Report Form (CRF) Management
- Each research institution and/or investigator is responsible for retaining study documents even if support has been discontinued and/or the site has been closed.
- However, there may be extenuating circumstances under which DAIDS may take custody of the clinical research records or recommend the transfer of records to another research site. An example of this may be if a site is closed to research or in the case of resource-limited settings, the site is defunded. In these circumstances, the investigator will work with DAIDS to determine the research record’s disposition.
The DAIDS RSC Case Report Form (CRF) Management Team works closely with DAIDS and Clinical Research Sites to facilitate this process.
This page is designed to walk users through the process of determining whether a Clinical Research Site’s CRF documents can be transferred to DAIDS for long-term storage, and if so how to complete that process. It also provides information on what to do with documents that cannot be transferred to DAIDS.
For more information, see the CRF FAQs.
Identification of Documents that Can Be Accepted by DAIDS for Storage
1. What types of documents can be sent to DAIDS?
Only CRFs and pharmacy records (except for participant prescriptions) may be shipped to DAIDS via the DAIDS RSC for long-term storage.
2. How can I determine the protocols for which documents can or cannot be sent to DAIDS?
The DAIDS RSC CRF Management Team works closely with DAIDS to keep up-to-date lists of IND and non-IND DAIDS-sponsored or -funded protocols that are no longer required to have their CRFs or Pharmacy Records retained to be in compliance with regulatory regulations and DAIDS policies. These are the protocols for which DAIDS WILL NOT agree to have documents sent for long-term storage since DAIDS has determined that the documents associated with these studies no longer require storage and that they may be destroyed in accordance with the investigator’s institutional policies.
If your protocol IS included on the lists, then DAIDS will NOT agree to have the documents sent for long-term storage. Refer to Question 3 below for information on what to do with your documents.
If your protocol IS NOT included on the lists below, then you can continue with the process for Sending CRFs to DAIDS for Storage as outlined in the “Process for Sending CRFs to DAIDS for Storage” section below.
Lists of protocols having CRF/pharmacy records that will NOT be stored by DAIDS
3. What should be done with the documents that CANNOT be sent to DAIDS?
The Clinical Research Site needs to confirm with their institution whether they can destroy the records from the protocols listed in the files above. Neither DAIDS nor the DAIDS RSC confirms destruction of any records by sites.
Process for Sending CRFs to DAIDS for Storage
The Instructions document outlines the processes for receiving DAIDS approval and the transfer of the CRFs and pharmacy records. Any questions regarding this process should be addressed to the DAIDS RSC CRF Management Team at firstname.lastname@example.org
1. Use the lists above to determine whether your documents can be accepted by DAIDS for storage.
2. Request authorization to ship your documents by emailing the DAIDS RSC CRF Team at email@example.com.
The Principal Investigator is responsible for submitting the request for authorization to ship CRFs and pharmacy records to DAIDS via the DAIDS RSC.
3. Ship your documents following the below instructions.
- Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC
- Use the below template to provide a detailed list of the documents for transfer.
CRF Master Inventory List Template
After DAIDS approval, the DAIDS RSC is responsible for receiving and repacking the CRFs and pharmacy records from the sites for transfer to long-term storage.