The CROMS contract provides a broad range of support for Division of Microbiology and Infectious Diseases (DMID) extramural clinical research programs. The Office of Clinical Research Affairs (OCRA), within DMID, facilitates the coordination of CROMS services.
The services provided by CROMS include
- Assistance in the preparation and review of protocols and protocol-related documents
- Clinical site assessment, monitoring, and reporting
- Receipt, assessment, and maintenance of essential regulatory documentation
- Training of clinical site personnel
- Pharmacovigilance and safety monitoring
- Protocol information tracking and reporting system
- Coordination and collaboration with other DMID-supported clinical research contracts
- Assistance with the preparation and review of site clinical quality management plans
A central website, DMID CROMS, describes the services and provides information and guidance to support the conduct and management of human subjects research.