OHSU

Identifying Research Subjects in Epic

All research subjects receiving clinical services as part of a study are required to be identified in Epic as being "associated" with that study.

Study staff are required to complete and email the Research Subject Study Status Change form to the Clinical Research Billing Compliance Office (CRBO) within 3 business days of subject consent AND when he/she is no longer receiving protocol-required clinical services on a research study.  **If your study is in eCRIS, the system will do this for you, and you do not need to send in the form. **

In addition, there are specific situations in which patients need to have a preconsent research association placed prior to consent.  This is detailed below.  This remains the same regardless of whether your study is in eCRIS.

The CRBO will create or discontinue an Epic research association for the subject within 2 business days of receiving the form (if the study is not within eCRIS). An email acknowledgement will be sent to the study staff once this is complete. 

RESEARCH STATUS UPDATES AND URGENT ASSOCIATIONS

The research association clearly identifies those patients participating in clinical research studies.  For current participants, "Research Active" will display in the patient header. 

"Research Active" will also display if the patient has a "Preconsent"                               status on the trial. This status is used to allow research appointments to be scheduled for a future date. 

If a research appointment is needed within 24 hours and there is no study association for the patient in Epic, please put 'Urgent' in the subject line of the email submitting the Research Subject Study Status Change form to the CRBO.  Page the CRBO at pager 13801 with the MRN, Name, and IRB #.  Once the preconsent association is entered, the CRBO will contact study team. 

After the appointment has occurred the study team will need to fill out the form with the updated status information for that patient (i.e. Signed consent or not), unless the study is being tracked within eCRIS.  The system will update the status of the subject for the study team.

If the patient was discontinued from a study after the Epic upgrade in Aug 2011, "Research Inactive" will display in the header.  If the participant has never been on a research study (after August 2011), the research indicator will not appear in most Epic views. 

Click on the research indicator in the patient header to go to the Research Studies page.  The Research Studies page has additional details regarding any study associated with the patient, such as the title, IRB number, PI/study staff names and phone numbers, industrial account or zero charge account number, date of enrollment, and billing indicator. 

Research studies on which the patient is no longer active (if deactivated after Aug 2011) can be viewed by checking the "Inactive" box.  Click on the "Details" button for the trial to find the date a patient discontinued from the trial.

An additional way to view the Research Studies page is by clicking the Research Studies tab in the Clinical Navigator in Epic.  This tab appears once you have clicked on the research indicator in the patient header at least once. 

If the patient participated and discontinued from a research study prior to August 2011, you can still view  these studies by going to "More Activities" and clicking on "FYI".  Then click on the "Show Inactive" button on the top right of the screen.

URGENT RESEARCH ASSOCIATIONS

 

If a research appointment is needed within 24 hours and there is no study association for the patient in Epic, please put 'Urgent' in the subject line of the email submitting the Research Subject Study Status Change form to the CRBO.  Page the CRBO at pager 13801 with the MRN, Name, and IRB #.  Once the preconsent association is entered, the CRBO will contact study team. 

After the appointment has occured the study team will need to fill out the form with the updated status information for that patient.  (Active = Signed consent or Did not sign consent = Association will be deleted).  If the study is in eCRIS and the subject enrollment has been added, this step does not need to be performed, as eCRIS will push the subject enrollment information to Epic.