This section contains policies and standard procedures for conducting Division of Microbiology and Infectious Diseases (DMID)-funded and/or -sponsored clinical research.
Overview of the NIAID Division of Microbiology and Infectious Diseases Office of Clinical Research Affairs.
Contains selected regulations and guidelines for Good Clinical Practice (GCP).
Links to policies and guidelines, including clinical terms of award, safety guidelines, and gender/minority reporting guidelines.
Clinical quality management plan development policy and tools.
Instructions on developing protocols and guidelines on how to assign version numbers when developing DMID documents.
An overview of DMID's centralized pharmacovigilance program, as well as SAE reporting guidelines and forms and Toxicity Tables.
Links to safety oversight policies and guidelines as well as conflict of interest (COI) forms completed by members of the safety committee.
Guidelines describing storage, handling, and accountability of study products and Vaccine and Treatment Evaluation Unit research site assessment guidance.
Information on DMID clinical research training modules.
Links to Human Subject Protection information, Federal Department of Agriculture clinical research information, World Health Organization research tools, and other resources.
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