Foundational Training in Clinical Research Operations and Regulatory Requirements
This self-paced online course is recommended for principal investigators, sub-investigators, clinical research coordinators, clinical research associates, and other study team members who function in these capacities. The program highlights many of the processes needed to initiate, manage, and close out a study at the University of Kentucky.
Format: PI 101 courses are delivered online through Canvas in a self-paced format. To complete a course, you must review all content and pass applicable module quizzes. You can download a certificate of completion for each course you successfully complete.
PI 101 was developed through collaboration between the Center for Clinical and Translational Science (CCTS), Markey Cancer Center (MCC), the Office of Research Integrity (ORI), and Center for the Enhancement of Learning and Teaching (CELT).
Program Curriculum
PI 101 is composed of three courses—Study Initiation, Study Maintenance, and Study Close—and covers the following topics:
- PI Responsibilities
- Training Responsibilities
- Types of Studies
- Committee Reviews, Approvals, and Agreements
- Financial Considerations
- Documentation & Training
- Reporting Responsibilities
- Quality Management
- Financial Responsibilities
- Stages of Study Close
- Reporting
- Long-term Storage and Archiving
- Material and Data Transfer
You must submit a request to enroll in PI 101. You will be notified via email with instructions on how to access the courses in Canvas once your request has been processed.
Contact
For questions and feedback, please contact us at PI101@uky.edu.
