In an effort to improve the efficiency of clinical research studies and increase the safety of patients who participate in these studies, the policy on documenting patient participation as subject in research (UIHC policy policy IM-MR-06.21) has been updated.

This policy leverages the availability of the “research module” in the Epic electronic health record to identify patients who are also subjects in research studies and provide information on the studies they are involved in. This research module also improves the management of the subjects who are in a study and simplifies billing of research funding sources.

This site contains resources to help researchers understand this new policy and follow good practices for implementing it.

Policy

A copy of the policy IM-MR-06.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC is located here.

Policy Awareness Course

All clinical researchers who participate in human subjects research are required to take the policy awareness course titled "Documentation of Participation in Study Protocol" once. The course is #WICTS1. 

All clinical researchers who need to associate subjects in the EPIC medical record are required to take the policy awareness course titled Associating a Research Subject in EPIC | UI Compliance & Qualifications (uiowa.edu) The course is #WICTS2

Training

Both trainings are now available in HR Self Service

Contact

If you have a question regarding this policy or need help with training or implementation, please contact ICTS support or Kristy Mahan.

 

Help the Institute for Clinical and Translational Science at the University of Iowa continue making new strides in medical research by citing the NIH CTSA program grant UM1TR004403.