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WashU Clinical Research Staff Additional Training Modules to Support BJC Compliance and Accreditation Requirements

Published May 14, 2024, via Research News

To support our BJC partner in meeting its compliance and accreditation requirements, we are asking Washington University clinical research staff to complete additional training modules.

First, any clinical research staff member who is in a patient-facing role and who may access any BJC location in conducting a clinical study must complete BJC Regulatory Compliance Education by June 30, 2024. The online training will be accessed through BJC’s Saba system. The BJC Saba module can be accessed through the Learn@Work system by accessing BJC Saba, then using the search feature to search by course name – BJC – Regulatory Compliance Education – 2024.

Please refer to the document titled “How to access BJC Saba for WashU Employees” for detailed instructions.

Second, in line with our commitment to uphold the safety of our clinical research participants and to align with BJC’s staff training, Washington University has also developed a training program for clinical research staff members for the following clinical skills: venipuncture and nasopharyngeal swabs. The clinical training requirements apply to any WashU clinical research team member utilizing one or both skills as part of study protocol on a BJC registered patient; the clinical training must be completed prior to performing either skill in a BJC facility. It only needs to be completed once, and any WashU clinical RN or MD may check off an applicable employee. Documentation of training completion must be kept on file (e.g., Box folder or paper file) and readily available. This training will be provided by the WashU clinical departments.

Finally, the BJC Regulatory Checklist should be signed and completed once the online training in Saba and the clinical skills training (if appropriate) are completed. The requirements in the top portion of the Checklist under “HR/Occ Health Requirements” have been verified that they align with WashU HR and Occupational Health for patient-facing clinical research roles upon hire. So the WashU staff member just needs to initial and date. The last portion of the Checklist under “BJC Policies & Procedures” lists the key policies and how they can be accessed; but it is NOT a requirement that a WashU staff member reviews them in detail. Each of the policies are addressed in the BJC Saba module and the Saba training fully satisfies this requirement. The completed checklist must be kept on file and readily available. We recommend that each WashU research group’s supervisor or manager keep each applicable staff member’s checklists in a Box folder. BJC Regulatory Checklist requirements must be completed by June 30, 2024.

Resources:

Please contact your direct supervisor and/or Yi Zhang at yizhang@wustl.edu with any questions.

Roz Corcoran, RN, MSN
Executive Director, Quality, Safety, Accreditation/Clinical Compliance and Occupational Health/WorkComp
BJC Healthcare

Suresh Vedantham, MD
Assistant Dean for Clinical Research
WashU School of Medicine

Yi Zhang, JD, RN
Assistant Dean for Clinical Research
WashU School of Medicine

Stacey House, MD, PhD
Vice Chair of Clinical Research
Dept. of Emergency Medicine
WashU School of Medicine