Documenting Research Activities in Epic
Per OHSU Healthcare System policy Research Documentation in the Integrated Health Record, if your study involves research subjects receiving clinical services (any procedure, test, or exam performed by an OHSU licensed practitioner including but not limited to blood draws, imaging procedures, clinical lab tests, non-invasive examinations, and dental work) in the context of a research study, including studies comprised completely of standard clinical care:
- The research subject must be assigned a Medical Record Number (MRN) via a MRN Request Form if the subject is not already an OHSU patient.
- A copy of their informed consent form must be scanned into the Integrated Health Record (IHR).
- All clinical information generated for a research subject that could at any time be used to make clinical decisions must be documented in the IHR. Point-of-care test results supporting clinical decisions should be documented in the IHR only if the test has been authorized by the Medical Director holding the OHSU CLIA license and performed by individuals who have demonstrated both written and hands-on competency.
- If the study involves inpatient nursing staff, an Inpatient Research Nursing Communication Order containing the study Research Nursing Summary Form must be placed immediately following admission of the subject.
The study staff must inform the Clinical Research Billing Compliance Office (CRBO) within 3 days of the patient signing consent and when they are no longer receiving protocol required clinical services on a study via the Research Subject Study Status Change form. The CRBO will update the research association in Epic. Instructions are listed in the Identifying Research Subjects in Epic section.
Research Instructions in Epic for Clinicians
For information on how to communicate research instructions in Epic to clinicians using Inpatient Provider Sticky Notes, Inpatient Research Nursing Communication Orders, and the Research Protocol Patient Problem list, you can view Communicating Research Instructions to Clinical Personnel in Epic.
New Epic Research Documentation Functionality - Feb. 2012
Research Documentation,Smart Phrases and Research Bookmark
Now available in Epic are three template smart phrases that can be bookmarked in a patient's record as research documentation of different types of consent form actions;
- Study completion
Study and patient specific information are added to the Smart Phrases each time one is utilized. These can be bookmarked as "Research" for easy reference and viewed in the Encounters on a patient's record. Please click here for step by step instructions.
Return to Epic & Research Subjects page.