Note: The information on NIAID’s investigator-initiated clinical trial (IICT) pages is being updated. Refer to the scientific/research contacts listed in our IICT funding opportunity announcements if you have any questions.
The Division of Microbiology and Infectious Diseases (DMID) supports extramural clinical research to control and prevent diseases caused by virtually every human infectious agent (except HIV). For the purpose of this website “clinical research” refers to research conducted on human subjects or on material of human origin that can be personally identified. This term applies to both clinical trials and clinical studies.
The pages on this site provide policies, guidance and tools developed by DMID. The “Selected References” page provides links to references cited on the DMID pages and documents, and are some of the most frequently referred to in clinical research.
- Agreements for Clinical Research
Information about different type of agreements negotiated between NIAID and outside parties for the conduct of a research project - Assay Requirements
- Clinical Quality Management
This page includes DMID’s policy for the development Clinical Quality Management plans with guidance and sample tools - Clinical Site Management
This page contains information and links for DMID staff and clinical site investigators to aid in meeting the expectations and obligations for managing clinical research - Data Management
Policies and other information directed at the handling of clinical research data - DMID Quality Management System Glossary
A glossary of terms used in documents in the Division of Microbiology and Infectious Diseases Quality Management System - Good Clinical Practices (GCP) and Human Subjects Protections (HSP)
DMID GCP Resource Guide, policies, and links to guidance and regulations - IND/IDE Management
- Institutional Review and Federal Wide Assurance
Policy, guidance, and references for information on IRB review and requirements for FWAs - Investigational Product
Information on ordering, as well as guidance and procedures for the handling and distribution of clinical investigational products - Protocol and Informed Consent
Policies, templates, tools, and guidance, including version control and translation requirements - Record Retention
Guidance on the retention of clinical research documents - Safety and Pharmacovigilance
DMID policies, guidance, toxicity tables, and forms for adverse event assessment and reporting - Safety Oversight Committees
DMID policy and information on the constitution and operations of DMID safety and data oversight committees, including conflict of interest forms - Specimens
Information and guidance on the use of clinical research specimens - Study Volunteers
Policies and references specific to enrolling clinical research volunteers - Training
Links to clinical research training, including HSP and GCP training modules - Selected References
Links references that include: NIH and NIAID policies and tools; regulations; ethical standards; and other frequently cited relevant references