Manual Sections and Appendices

• Introduction to DAIDS Systems
• Investigator Responsibilities
• Clinical Research Site (CRS) Personnel Qualifications, Training, and Responsibilities
  • Training Log Template (Trainee specific)
  • Training Log Template (Training Topic Specific)
  • Guidance on Completion of Delegation of Duties Log 
  • Division of AIDS (DAIDS) Delegation of Duties Log 
  • Delegation of Duties Log Frequently Asked Questions
• Pharmacy Requirements
• Electronic Systems
• Clinical Research Site (CRS) Facility Requirements (Clinic, Laboratory and Additional Locations)
• Laboratory Requirements
• Source Documentation
  • Source Documentation Requirements
• Essential Documents
  • Note to File template
  • Essential Documents Recordkeeping 
  • Record Retention Flow Chart
• 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
  • Clinical Research Site Requirements for the CRS-specific Informed Consent Process Standard Operating Procedure
  • Clinical Research Site Requirements for Enrolling Minors into DAIDS Clinical Research
• 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 Visit Log Template
• Clinical Research Site Inspection Readiness
  • Inspection Preparedness Standard Operating Procedure Template
  • Guidance on Site Regulatory Inspection
  • Log of Copied Documents Template
  • Clinical Research Site Inspection Preparation Checklist 

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
  • 21 CFR part 11 (Electronic Records; Electronic Signatures)
  • 21 CFR part 50 (Protection Of Human Subjects)
  • 21 CFR part 54 (Financial Disclosure By Clinical Investigators)
  • 21 CFR Part 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application)
• 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.

• Frequently Asked Questions