This page features updates from the NIH, DAIDS, and more affiliated departments within the NIH.
Expansion of Remote Pharmacy Monitoring (27 August 2021) and Delegation of Duties Log Template (30 August 2021)
The DAIDS Office of Clinical Site Oversight (OCSO) has released two memoranda related to the Expansion of Remote Pharmacy Monitoring and Minor Updates to the DAIDS SCORE Manual: DAIDS Delegation of Duties Log Template. Both are posted on the HANC website under the DAIDS Resources page.
Updated DAIDS Manual for Good Clinical Laboratory Practice Guidelines (16 August 2021)
The DAIDS Office for Policy in Clinical Research Operations (OPCRO) has released the updated manual “DAIDS Good Clinical Laboratory Practice Guidelines” for all DAIDS-sponsored clinical research laboratories.
The Manual has been updated with the major changes listed in the Version History table on pages 62-63. The Manual can be found here.
Policy for Study Progress, Data, and Safety Monitoring Plan (15 July 2021)
The DAIDS OPCRO announced the availability of the updated policy, “Policy for Study Progress, Data, and Safety Monitoring Plan” for all DAIDS-sponsored clinical research.
This policy has been updated to (1) modify the scope to include all clinical trials sponsored by DAIDS, NIAID, and (2) to remove appendices and information that were not within the revised scope of this policy. The Policy can be found at: https://www.niaid.nih.gov/research/daids-clinical-research-event-reporting-safety-monitoring
Electronic Information System (4 June 2021) and EIS Evaluation Checklist (24 June 2021)
The DAIDS OPCRO announced the availability of the updated policy, "Electronic Information System (EIS) Policy” and associated “Electronic Information System Evaluation Checklist.” This policy has been updated to clarify the scope and clarify validation responsibilities for non-COTS (Commercial Off the Shelf) systems.
The associated checklist has been updated with minor changes. The checklist and associated Policy, additional Appendices, and Frequently Asked Questions (FAQs) can be found at: https://www.niaid.nih.gov/research/daids-clinical-site-implementation-operations.