Bridging the Gap: Commercialization for Clinical Researchers is a four-week course series that equips junior faculty interested in realizing commercial impact with the knowledge, attitudes, and skills necessary to enter into and successfully navigate a research commercialization or tech transfer effort. The courses are designed to allow learners to gain a general understanding of the technology commercialization landscape, then apply that knowledge in a practical manner to an innovation. 

GCP-FDA Training provides online and face-to-face, team-based learning opportunities to explore the clinical trial research process as it applies to Good Clinical Practice.

 Learners will become familiar with the thirteen principles of GCP and apply the principles to the initiation and conduct of a clinical trial. Learners will also learn the roles and responsibilities of key players involved in a clinical trial. These include: IRB, FDA, sponsor, Investigators, coordinators, DSMB and participants.

 Finally, learners will transfer the ideas of participant safety and quality data management to the workplace.

GCP-FDA Training course consists of four face-to-face laboratories and five online modules. You are encouraged to complete all module work before coming to your first laboratory.

Course Policies

Learners participating in the GCP-FDA Training Course are expected to maintain high degrees of professionalism, commitment to active learning and participation in this class and also integrity in their behavior in and out of the classroom.

Please contact us as soon as possible to discuss appropriate academic accommodations that may be required for student with disabilities.

We appreciate your passion for clinical research and look forward to having you in the GCP Training course.

Hosted by CTSC REDCap administrator Kevin Wesley, this video course introduces the learner to the basics of using REDcap.