DMID Clinical Research Policies and Standard Procedure Documents

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)

Healthy Volunteers (PDF)

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

• DMID Translation Equivalence Form (Appendix A) (MS Word)

• DMID Language and Translation Requirements Summary: Essential Document Requirements and Instructions (Appendix B) (MS Word)

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)