Frequently Asked Questions
1. How did this training program get started?
The Study Coordinator Development Program started out of resources afforded by the CTSA grant. The program is a collaborative creation by multiple departments at KUMC. Members of the KUMC Human Research Protection Program (HRPP), the KUMC Research Institute (RI), KUMC Department of Biostatistics, along with input from many other individuals designed the core curriculum, content and websites for the program.
2. Who needs to participate in the development program?
All Study Coordinators must take part in the development program. You are considered a study coordinator If:
· you are currently listed, or will be listed in the future, as a study coordinator on a clinical research project
· you perform activities on a clinical trial consistent with study coordinators
· you are registered as a study coordinator with the KUMC Research Institute
3. How frequently is the training required?
Training must be updated on an annual basis. Completion of training is tracked by the HRPP Quality Assurance Program and the KUMC Research Institute.
4. How do I know what training I need to complete?
All study coordinators must complete the basic training modules one time. This is a set of 12 training modules dealing with tasks/situations study coordinators encounter. Completing the basic training modules will take about 6 hours. The modules can be completed over the course of 3 months.
Designated study coordinators will complete additional modules, based on the types of studies they coordinate. For example, specific modules are offered on FDA-regulated studies, medical devices, and research billing. These additional modules are required when they are applicable to the coordinator’s duties.
Each year, training modules will be updated, or new modules added, to meet the needs of study coordinators and of the compliance program. You will be notified by the HSC or KUMC RI when your training is to be renewed.
5. How will the training modules be offered?
Training modules are offered in a variety of ways. You will be able to complete training via:
a. In person classes/talks/workshops/lectures
b. Online webinars
c. Online presentations
d. Online quizzes based on articles/readings
6. Is training available for people at Frontiers affiliates?
The development program is being initially rolled out to only KUMC employees. After the program is fully implemented at KUMC, it will be offered to employees at all Frontiers affiliate institutions. This roll out is anticipated to occur Spring 2014.