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 DMID Clinical Research Operations And Management Support (CROMS) WebLibrary includes topic-specific training modules available to DMID Staff and Investigators with authorized access. To request access to the CROMS training modules, please submit a request using the Systems Access Request Form.
The following training opportunities are available (for authorized users only):
- 45 CFR Part 46
- Adverse Events/Serious Adverse Events
- Clinical Quality Management — 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
- Essential Regulatory Documents
- FDA Site Inspections and Audit Preparedness
- Federal-wide Assurance (FWA)
- Informed Consent
- Investigator Responsibilities – This module is available in French , Mandarin , Portuguese , Spanish , and Thai
- Regulatory Document File Guidelines
- Source Documentation Standards
- Study Product Management
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.
NIH Clinical Center International Clinical Research Training