Regulatory Support & Education Program
The Regulatory Support and Education Program is committed to helping investigators and their study teams navigate the regulatory requirements governing clinical research through a variety of services. For inquiries about any of the services listed below, please call or e-mail us or submit a Request for CRRO Services Form.
– A growing list of tools and resources….
- Assistance with IRB application preparation including: development of Data Safety Monitoring Plans (DSMPs), writing and editing of consent forms, fulfilling of HIPAA requirements, etc. Assistance with study design, statistical issues, and forms development is also available through referral to experts within CTSI.
- Study Implementation: assistance with questions about regulations, policies, and guidelines to help ensure effective processes related to documentation, consenting, eligibility determination, AE monitoring/reporting, etc.
- Guidance with sponsor-investigator responsibilities and obligations in conduct of IND/IDE research, including assistance with preparation and submission of IND/IDE applications to the FDA and management of IND/IDEs.
Many educational trainings and workshops to choose from!
The CRRO conducts quality assurance reviews of new and on-going research studies to ensure that IRB-approved research studies are conducted in compliance with applicable regulations, policies and guidance.