Research Regulatory Specialist
For Investigators
The CTSC Research Regulatory Specialist will assist investigators in all aspects of regulatory document preparation to ensure that research studies are in compliance with local, state and federal regulations.
The Specialist provides the following:
- Research Proposal & Consent Form assistance
- Guidance on web-based tools for investigators when appropriate
- Guidance on accessing all necessary submissions to institutional compliance committees
- Adverse Event Reporting assistance and guidance
- Assistance in preparing and implementing Data and Safety Monitoring Plans (DSMP)
- Guidance on the necessary component for forming a Data and Safety Monitoring Board (DSMB)
- Research Investigator Startup Evaluations (RISE) Program to assist investigators in getting the best start possible
- Good Clinical Practice Training for investigators and research staff
- Independent monitoring (for studies prior to sponsor monitor of other audits)
