Division of Microbiology and Infectious Diseases (DMID) staff and investigators who have responsibilities associated with human subjects research must have training commensurate with the type(s) of human subjects research under their purview and their related level of responsibility as well as a working knowledge of appropriate regulations. The following training opportunities are available to staff and investigators.
DMID Clinical Research on-line modules are short, topic-specific training:
- 45 CFR Part 46 (for authorized users only)
- Adverse Events/Serious Adverse Events
- Clinical Quality Management Plan Training Module—This course provides comprehensive instruction in the development of Clinical Quality Management Plans. The module provides the user with on-demand access to supportive references. For additional instruction on linking to this module see the Clinical Quality Management page
- DMID Regulatory Document File Guidelines
- DMID Source Documentation Standards (for authorized users only)
- Essential Regulatory Documents (for authorized users only)
- Federal-wide Assurance (FWA) (for authorized users only)
- Study Product Management
- Investigator Responsibilities. This module is available in French, Mandarin, Portuguese, Spanish, and Thai. (for authorized users only)
GCP: NIAID on-line training (requires login)—This course is offered by NIAID and covers the scientific and ethical standards of human subject research, including the National Institutes of Health (NIH), Food and Drug Administration, and U.S. Department of Health and Human Services, and international clinical trial policies, guidelines, and regulations. Completion of all four modules meets the DMID training requirement for GCP and HSP training.
Global Trace Use (for authorized users only)
Human Subject Protections (HSP): NIH on-line training. This course meets the DMID staff requirement for training in HSP for staff with responsibilities for human subject research.