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.
Studies that are in eCRIS will have research associations automatically added to Epic when study staff add a consented subject into eCRIS. Study staff are required to enter consented subjects into eCRIS within 3 business days of subject consent. The research association will be automatically removed from Epic when the study team completes the visit that transitions the subject to Off Study in eCRIS.
The study teams will no longer need to fill out the Research Subject Study Status Change form unless there is a subject that needs a "Preconsent" research association added in Epic (An Epic research encounter can then be scheduled).
Preconsent requests still need to be sent in on the Research Subject Study Status Change form to the Clinical Research Billing Compliance Office (CRBO).
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 Preconsent 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 only needs to send an updated form if the subject did not sign consent and no longer needs the Preconsent research association in Epic. When the study team enters the consented subject into eCRIS, the research association will be updated automatically within Epic. 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 view. 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.
Return to Epic & Research Subjects page.
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 occurred the study team will only need to fill out the form again if the subject did not sign consent ( Association will then be deleted). If the study is in eCRIS and the subject enrollment has been entered, eCRIS will push the subject enrollment information to Epic automatically.