The Center for Clinical Research Management (CCRM) Regulatory and Compliance team provides support for investigators, sponsors and research teams who are navigating the regulatory framework surrounding clinical research.
Our goal is to assist faculty in their pursuit of medical innovation and discovery while fulfilling all aspects of research ethics and compliance.
The Regulatory and Compliance team is responsible for:
- Preparation and submission of applications and all corresponding documentation to the Institutional Review Board (IRB) from study initiation through closure (including but not limited to initial IRB applications, amendments, personnel changes, continuing reviews, annual reports, and study closures)
- Processing all other required regulatory submissions and facilitating other committee approvals (e.g. Clinical Scientific Review Committee, Institutional Biosafety Committee, Human Subject Radiation Committee) as needed per protocol
- Providing protocol and other document feedback to ensure compliance with regulations
- Developing informed consent forms as needed
- Obtaining other supporting documentation from the investigator/study team as applicable (e.g. recruitment materials, data collection forms, subject facing materials) for IRB submission
- Securing sponsor approval of regulatory documents as applicable
- Tracking investigator conflict of interest (COI) identification and management
- Completion and maintenance of all required regulatory forms and agreements
- Creating initial study binders to provide to study teams
- Providing submission and approval documents to investigators and study team members over the life of a protocol
- Serving as the primary contact (other than Principal Investigator) for the IRB
- Serving as primary regulatory contact for sponsors
- Monitoring/auditing of regulatory documentation
- Providing guidance on adverse event report form completion as needed in conjunction with the CCRM Operations team
- Ensuring investigators have current required credentials and training
- Participating in internal and external audits as needed
- Monitoring all regulations and guidance to identify and implement any changes to regulatory requirements and processes
- Entering all regulatory data and documentation into the OnCore database
Regulatory Resources
- Center for Clinical and Translational Science
- Clinical Scientific Review Committee
- Clinical Trials Registration
- Ohio State College of Medicine Office of Research Compliance resources
- eCOI Disclosure process
- Human Gene Transfer Research Responsibilities and Compliance
- Office of Responsible Research Practices
- U.S. Food and Drug Administration