The Clinical Research Study Staff Orientation Program provides one option for complying with the Medical Center policy that any person named as the designated Study Coordinator in the eIRB for a human research protocol must demonstrate a minimum level of competence regarding human subjects research. The program is comprised of one comprehensive training module which evaluates key knowledge for implementing human research protocols in accordance with regulatory guidelines and institutional policies.
If you are a new study coordinator we recommend that you take this program. If you are an experienced study coordinator you may take the Clinical Research Study Staff Continued Competence Test. A score of 80% or higher is required to pass the test. If after two attempts you fail the test you will need to complete the entire Clinical Research Study Staff Orientation Program.
- To enroll in the program, log into HealthStream using your Medical Center user ID and password.
- Click on the Catalog button and enter “Clinical Research Study Staff Orientation Program” in the search box.
- Click on the title and then click the Enroll button. It will be now be added to your To Do list.
- Click on the To Do button to go to the list and start the training.
Background
The Common Rule outlines Investigator Responsibilities in section 46.104: the Principal Investigator of a clinical research study is “responsible for ensuring that members of the research team, including study staff and trainees, are appropriately qualified, trained, and supervised.” This training is part of our ongoing effort to assure that those involved in human subjects’ research have the necessary knowledge and skills to perform their assigned clinical research responsibilities. Current policy requires that all study team members must complete CITI training. The training required by the Medical Center policy builds upon CITI training and provides further foundational knowledge that includes: content on Principal Investigator responsibilities, key aspects of study initiation, study management, study closeout, relevant guidelines, federal regulations, policies and how these are operationalized at Wake Forest Baptist Medical Center.
Questions and Support
For questions about the Medical Center policy and its implementation, please contact:
Joseph Andrews, PhD
Assistant Dean, Regulatory Affairs and Research Integrity
Clinical and Translational Science Institute
Brian Moore
Director, Institutional Review Board
Clinical and Translational Science Institute
For questions or problems with the online training modules, please contact CTSIeducation@wakehealth.edu.