Clinical Research Policies and Guidelines
Clinical Terms of Award (CTA) (PDF): Describes the researchers roles and responsibilities for both the awardee and the program officer.
Clinical Terms of Award (CTA) Guidance Document (PDF): 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)
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)