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Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

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, guidances 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

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

Good Clinical Practices (GCP) and Human Subjects Protections (HSP): DMID GCP Resource Guide, policies, and links to guidances and regulations

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

Glossary of Terms: Definitions of terms

Selected References: Links references that include: NIH and NIAID policies and tools; regulations; ethical standards; and other frequently cited relevant references

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Last Updated September 30, 2015