Central Virginia

“Ensuring Regulatory Compliance as a Study Team Member” 

Date: Wednesday, August 24, 2022

Time: 11:00am – 12:00 pm

Location: Zoom, registration required

Speaker: Bret Brooks
Bret is a Certified Clinical Research Coordinator in the VCU School of Nursing Office of Research, Scholarship, and Innovation. Bret started in the VCU SON in February of 2021 after working in the Department of Internal Medicine at VCU where he was a Clinical Research Associate and Regulatory Specialist working on various industry-funded clinical trials. He currently coordinates 2 studies in the SON: the RECOVER-LEGACI Long COVID study and the PRenatal opioids, Infant Sleep, and the gut Microbiome (PRISM) study. Bret’s biggest motivation and ultimate research career goal is to increase access to research for the most underserved and historically-excluded populations and help to translate that into healthcare for our most vulnerable communities.


Learning Objectives: At the conclusion of this presentation, the learner will be able to:

• Discuss the transformation of abstract regulations and guidelines into specific SOPs and best practices for a study or research program.
• Learn strategies to maintain study data and essential/source documents in an audit-ready state.
• Briefly discuss the relationship between and importance of regulations and ethical standards, and identify some of the impacts on research participants, with a focus on the most vulnerable communities and populations.
  
  

JTF Competencies
Domain #2: Ethical & Participant / Safety Considerations
Domain #4: Clinical Study Operations
Domain #5: Study & Site Management