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

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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)

DAIDS Protocol Documents Policy (PDF)


DAIDS Protocol Documents Manual (PDF)


DAIDS Protocol Documents Template (PDF)


Requirements for Informed Consent Development (PDF)


Related Documents

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

Last Updated April 30, 2015