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Site Management
This page contains information and links for Division of Microbiology and Infectious Diseases (DMID) staff and clinical site investigators. Information on this page is relevant for both clinical studies and trials.
Clinical Terms of Award: The Clinical Terms of Award detail terms that awardees must comply in order to receive their award. Terms are associated with all grants and contracts that involve clinical research.
NIAID Clinical Terms of Award – Guidance for Compliance: Identifies the documentation and approvals that are necessary for NIAID-supported clinical research.
Clinical Site Monitoring: DMID-funded clinical trials filed under an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) or an international equivalent will have clinical site monitoring. DMID provides clinical site monitoring for all trials for which it is the regulatory sponsor. Other trials may be monitored as determined by DMID.
DMID will conduct site monitoring visits as detailed in the monitoring plan or in the Manual of Procedures. Site visits will be made at standard intervals as defined by DMID and may be made more frequently as directed by DMID. Monitoring visits will include, but are not limited to, review of regulatory files, accountability records, case report forms, informed consent forms, medical and laboratory reports, and protocol compliance. Study monitors will meet with investigators to discuss any problems and actions to be taken and document visit findings and discussions.
Standard Operating Procedures (SOPs): DMID expects sites to have in place SOPs based on the operational requirements of the protocol and to have available for inspections site specific SOPs, e.g., for a laboratory hood testing and cleaning, and for a clinical trial site consenting or pharmacy procedures.
DMID Policies
- Guidance on Form FDA 1572 Sub-investigators
- NIAID GCP HSP Policy
- Good Clinical Practice Training for Awardees
- Human Subjects Protections Training for Awardee Clinical Research Staff
- Medical Officer Assignments and Responsibilities in DMID Protocols
- Training Requirements for Clinical Site Staff
DMID Guidance's and Tools
- Clinical Research Operations and Management Support (CROMS) provides staff and DMID researchers with clinical management support information including monitoring, training, and tools. The Clinical Research Support and Training Modules on the CROMS site are accessible to the public. DMID investigators who do not have a password must request access to other sections of the site. Request access/privileges.
- Clinical Trial Site Monitoring
- Essential Document Collection and Review Process for VTEUs and Phase 1 Units (for authorized users only)
- Notes to File Guidelines
- Regulatory Document Guidelines
- Source Documentation Standards
