Regulatory Support
Regulatory Specialists are available to assist investigators with submissions and reports to sponsors and/or institutional oversight bodies. Investigators are encouraged to contact the CTIU at the beginning of grant or protocol development or prior to budget negotiations for industry sponsored research studies. However, the CTIU is available to help investigators at any point during the course of a research study. Regulatory services are available for both investigator-initiated and/or industry sponsored research studies, and can assist with IND and IDE projects.
Once a request is made through the TRI Services Portal, a team member will contact the investigator to discuss research needs. The CTIU will then conduct a feasibility assessment and may require a meeting with the investigator and other members of the study team. Once CTIU support is determined, costs for regulatory support will be discussed.
For industry sponsored research studies, the CTIU will be available to discuss and help negotiate regulatory support costs with the sponsor. For grant proposals, this support will need to be built into the grant’s budget. Early CTIU involvement in the study startup process will help maximize the potential to start the study in a timely manner.
Regulatory Services include:
- Submission of protocols, modifications and amendments to the Institutional Review Board (IRB)
- Working with sponsors and study teams to complete required start-up regulatory packets
- Reporting of adverse events, continuing reviews and study closure to the IRB
- Maintenance of electronic regulatory binders
- Preparation and guidance throughout monitoring visits and audits
- New Investigator Consult and Education reviews with the Office of Research Compliance
- Honest broker for AR-CDR data requests
- Ensuring all members of the research team are certified in HIPAA, Human Subjects Protection, Good Clinical Practices and other study specific certifications.
Program Leadership
Please submit requests for regulatory services through the TRI Services Portal. Select Regulatory (IRB) when completing the request form.