Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents

Protocol and Informed Consent Development

This section provides links to policies and standard procedures related to the requirements for the creation of protocol and informed consent documents for DAIDS supported and/or sponsored clinical research.

Enrolling Children (including Adolescents) in Clinical Research: Protocol Document Requirements (PDF)

• Appendix 1 - Risk/Benefits Categories [CL.201] (PDF)
• Appendix 2 - Examples of Templated Language [CL.202] (PDF)
• Appendix 3 - Wards [CL.203] (PDF)
• Appendix 4 - Waivers of Parental/Guardian Permissions or Child Assent [CL.204] (PDF)

Requirements for Protocol Documents for DAIDS Funded and/or Sponsored Clinical Trials< (PDF)

• Appendix 1 - DAIDS Guidance for Protocol Documents (PDF)

Requirements for Informed Consent Development (PDF)

Related Documents

Protocol Registration Policy (PDF)

• Appendix 1 - Protocol Registration Algorithm (PDF)
• Appendix 2 - Protocol Registration Manual (PDF)
• Appendix 3 - Enrolling Children (including Adolescents) in Clinical Research: Clinical Site Requirements (PDF)

Use of Study Products Not Marketed in the United States Policy (PDF)