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.
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Recently Updated Processes and Procedures
- DAIDS SCORE Manual: Quality Management
- DAIDS SCORE Manual: Clinical Research Site Quality Assurance Summary Report
- DAIDS SCORE Manual: Site Visits
- DAIDS SCORE Manual: Investigator Responsibilities
- DAIDS SCORE Manual: Clinical Research Site Requirements for Enrolling Minors into DAIDS Clinical Research
- DAIDS SCORE Manual: Guidelines for Clinical Research Site (CRS) staff on Preparing the Bi-annual Quality Assurance (QA) Summary Report
- DAIDS SCORE Manual: Clinical Research Site Facility Requirements
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Manual Sections and Appendices
- Introduction to DAIDS Systems
- Investigator Responsibilities
- Clinical Research Site (CRS) Personnel Qualifications, Training, and Responsibilities
- Pharmacy Requirements
- Electronic Systems
- Clinical Research Site (CRS) Facility Requirements (Clinic, Laboratory and Additional Locations)
- Laboratory Requirements
- Source Documentation
- Essential Documents
- Quality Management
- List of Standard Operating Procedures (SOPs) Required at Clinical Research Sites
- Standard Operating Procedure (SOP) Template
- Clinical Quality Management Plan Template
- Guidelines for CRS staff on Preparing the Bi-annual Quality Assurance Summary Report
- Clinical Quality Management Plan: Protocol Regulatory File Review Tool
- Clinical Quality Management Plan: Participant Chart Review Tool
- Clinical Quality Management Plan: Clinical Research Site Quality Assurance Summary Report
- Clinical Quality Management Plan (CQMP) and QA Summary Report Frequently Asked Questions
- DAIDS Protocol Registration and Institutional Review Board (IRB)/Ethics Committee (EC) Communications
- Informed Consent of Participants
- Screening, Enrollment/Randomization, and Unblinding of Participants
- CRS Guidance for Developing an Age & Identity Verification SOP
- Age & Identity Verification Frequently Asked Questions
- Age & Identity Verification SOP Template
- Age & Identity Verification Explanatory Letter to the IRB/EC
- CRS Guidance for Developing a Co-enrollment Prevention SOP
- Co-Enrollment Prevention Frequently Asked Questions
- Co-Enrollment Prevention HIPAA/Privacy Frequently Asked Questions
- Co-Enrollment Prevention Template SOP
- Co-Enrollment Prevention Template Letter to the IRB
- Protocol Compliance
- Premature Termination or Suspension of a Clinical Trial
- Site Visits
- Clinical Research Site Inspection Readiness
Additional Requirements
In addition to the requirements outlined in this guide, CRS staff must also comply with:
- International Council for Harmonisation (ICH) Good Clinical Practice (GCP) (ICH E6) guidelines
- Any applicable United States (U.S.) Code of Federal Regulations (CFR) including
- In-country laws/regulations (e.g., European Medicines Agency (EMA), South African Health Products Regulatory Authority (SAHPRA), etc.)
- Institutional and Institutional Review Board (IRB)/Ethics Committee (EC) requirements
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.