The Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual describes operational requirements for Clinical Research Sites (CRSs) implementing DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. This manual serves as a resource for CRSs by consolidating operational requirements in a central location and providing tools to facilitate compliance with these requirements. CRS staff should direct any questions related to these requirements to their Office of Clinical Site Oversight (OCSO) Program Officers (POs) and/or the Pharmaceutical Affairs Branch (PAB) Pharmacists as appropriate.
DAIDS requires CRSs conducting clinical research that meet the National Institute of Health (NIH) definition of a clinical trial to follow all applicable NIH, National Institute of Allergy and Infectious Diseases (NIAID), DAIDS policies and procedures, as well as DAIDS Clinical Trials Networks processes and procedures.
In addition to the requirements outlined in this guide, CRS staff must also comply with:
If the clinical research is subject to U.S. Food and Drug Administration (FDA) and/or non-U.S. regulations, then the applicable requirements must be met. When multiple requirements apply, the most stringent of any of the requirements, processes, and/or procedures must be followed.
The SCORE manual was developed to describe the activities and DAIDS requirements for clinical trials. However, many sections are broadly applicable to all clinical research and should be followed by CRSs conducting these studies. Examples of sections that are applicable for all studies include: Informed Consent of Participants and Essential Documents.
Note: All DAIDS-supported and sponsored clinical research are subject to the U.S. Department of Health and Human Services (HHS) regulations delineated in 45 CFR Part 46.