DMID Clinical Research Policies, Guidance, and Tools

Clinical Research Policies and Guidelines

Clinical Terms of Award (CTA): Describes the researchers roles and responsibilities for both the awardee and the program officer.

Clinical Terms of Award (CTA) Guidance Document: Guidance for compliance with NIAID Clinical Terms of Award.

Regulatory File Document Guidelines (PDF)

Source Documentation Standards for Clinical Research (PDF)

DMID Translation Policy (PDF) and tools (MS Word)

• DMID Translation Equivalence Form (MS Word)
• DMID Language and Translation Requirements Summary: Essential Document Requirements and Instructions (MS Word)

DMID Requirements for Staff Training in Good Clinical Practice and Human Subjects Protections (PDF)

DMID Requirements for IRB/IEC Review of Human Subjects Research (PDF)

Development of Criteria for Volunteer Participation in DMID Clinical Research (PDF)

Expanded Distribution of Clinical Research Endpoint Data (PDF)

Unblinding Individual Participants in DMID Clinical Research (PDF)

Reporting

Gender/Minority Reporting Guidelines (PDF): Instructions for reporting women and minority inclusion in clinical research

DMID Policy Development

DMID Clinical Research Policy Development, Review and Approval for NCRS Documents (PDF)

Training

Staff Training in Good Clinical Practice and Human Subjects Protections (PDF)