After the recent Division of AIDS (DAIDS) Clinical Trial Unit (CTU) grant recompetition, CTUs and corresponding Clinical Research Sites (CRSs) have been selected for funding. DAIDS has placed each CRS into one of 3 scenarios for the transition into the new grant cycle. Each scenario requires a unique set of items to be completed for seamless flow of continued and/or new protocol activities. This will involve close coordination between the Clinical Trials Unit (CTU), the CRS staff, Office of Clinical Site Oversight (OCSO) Program Officer (PO), and the appropriate Network Staff.
Please click on the appropriate scenario definition below to open the scenario landing page. Please follow the directions on each page for the appropriate scenario(s) for each CRS in the CTU, as designated in the table provided in the CTU specific transition letter received from DAIDS. Due dates for completion of requirements are specified for each scenario below. Links throughout the pages will connect to applicable resources. Access to the DAIDS Learning Portal (DLP) will be necessary to access required trainings - please visit https://daidslearningportal.niaid.nih.gov to create an account.
Scenario 1 - Known to DAIDS CRS
- A CRS that participated in DAIDS HIV/AIDS Network clinical trials in the prior 7 year grant cycle and has been selected to continue participation in one or more DAIDS HIV/AIDS Network clinical trials in the 2021 grant cycle; or
- A previously fully funded CRS that has been selected by a Network and DAIDS to continue a specific protocol into the 2021 grant cycle but will be phased-out once the specific protocol is completed and the CRS is deregistered.
Scenario 2 - New to DAIDS CRS
A CRS that has been selected to participate in one or more DAIDS HIV/AIDS Network clinical trials in the 2021 grant cycle that has not participated in any DAIDS HIV/AIDS Network clinical trials in the prior 7 year grant cycle.
Scenario 3 - Phase Out CRS (or Network Affiliation)
CRS funded by DAIDS in the previous grant cycle (either fully funded or PS), where a proposed network affiliation(s) was not selected for re-funding in the next grant cycle. The CRS will complete all network protocol activity by November 30, 2021 based on DAIDS and Network Guidance.
Important Documents
Complete transition information in one pdf – CTU and CRS personnel should download this document if one document is preferred to navigating the transition landing pages, or if printing is required
DAIDS CRS Transition Scenario Checklist
Each CRS in scenario 1 or 2 will fill out a checklist. Download this document and complete it electronically, then return to your OCSO PO
OCSO CRS Closeout Site Checklist
Each CRS in scenario 3 that will be phasing out entirely in 2021 will need to complete this checklist
This manual is a reference to describe operational requirements for Clinical Research Sites (CRSs) implementing DAIDS-sponsored studies within the DAIDS Clinical Trials Networks.
NOTE: Please download the transition packet, transition checklist, and close-out checklist and open them in Adobe Acrobat for best functionality.