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.
– A growing list of tools and resources….
Consultation on 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.
Consultation on IRB application submission
– 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.
Support for sponsor-investigators of FDA-regulated research
– Guidance with sponsor-investigator responsibilities and obligations in conduct of IND/IDE research.
– Assistance with preparation and submission of IND/IDE applications to the FDA and management of IND/IDEs.
Quality Assurance Reviews
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. These reviews are educational and consultative in nature. The goal is to identify and help correct potential problems in study conduct, documentation, or process before they affect safety of participants and/or validity/integrity of study data. Quality assurance reviews may be initiated with a request from a principal investigator or after being selected by the CRRO for review. Priority for selection is given to studies that are investigator-initiated and greater than minimal risk, but any study may be chosen for review.
Quality Assurance Reviews are most beneficial when performed shortly after enrollment has begun, but may be done at any time during the study. Results of CRRO Quality Assurance Reviews are provided in writing to the PI, and a report is also provided to the Office of Clinical Research and the BMC Research Compliance Officer (for BMC studies only). The CRRO does not share the report with the IRB. Issues, such as unreported protocol deviations, identified during Quality Assurance Reviews will be the responsibility of the investigator to report to the IRB.