Essentials for Regulatory Specialists
A virtual workshop for University of Minnesota research professionals, such as regulatory specialists, research coordinators, and project managers, new to a regulatory role in human research studies.
What you'll learn
- The role and responsibilities of the regulatory specialist, and how to apply them to your work.
- How to develop study documents and maintain a regulatory binder.
- How to prepare and manage IRB submissions.
What to expect
You must attend both days of the virtual workshop, and complete the online training modules to earn a "complete" in your training hub record.
Who it's for
All research professionals such as regulatory specialists, coordinators, research nurses, project managers, etc. who are working on a UMN human research study and are either:
- New to taking on a regulatory role in research
- New to the University of Minnesota
Cost
Training is free for both departments and individual research professionals.
Prerequisites
It is highly recommended that participants complete Foundations for Research Professionals before taking this course. Attendees should already have the basic regulatory and IRB knowledge that is covered in Foundations.
To take the course, you must have completed the University’s training requirements for being a study team member, including:
- HIPAA Training
- CITI Training (Biomedical or Social/Behavioral)
A baseline knowledge assessment will be administered by the course instructor after registration. Complete this within one to two weeks of registration.