Microbiology and Infectious Diseases Clinical Research Policies and Standard Operating Procedures

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, 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
  • 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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