Patterson Naequel
This course covers coordinating and managing a clinical study from the perspective of the study site. Students will learn the essentials of coordinating and managing the day-to-day operations of a clinical research study, from planning site logistics and constructing timelines for the study-initiation visit to closing out a study. The course will focus on the process's operational, interpersonal, and data-management aspects.
Skills / Knowledge
- Demonstrate a working knowledge of the elements of effective clinical site preparation
- Review a protocol for feasibility, extracting study timelines and procedures
- Obtain informed consent from a study subject utilizing key content
- Complete regulatory documents and critical document binders that will pass audit standards
- Evaluate a template study budget in relation to the work necessary to complete the trial
- Prepare a submission for either a central or local IRB demonstrating an understanding of what each is looking for
Issued on
July 12, 2024
Expires on
Does not expire