2. Enrolling Eligible Subjects and Entering Screen Fails

TABLE OF CONTENTS

To Enroll a Subject

Begin on Home Page > Subjects menu >CRA Console
Select a protocol by entering the protocol number in the Select Protocol field
Find Subject and Click on “Epic MRN hyperlink”
Click the Eligibility Vertical Tab
1. Click “Update”
2. Enter the following fields into the “New Subject Eligibility” block:
  1. Status Date: date that the subject is found to be eligible
  2. Eligibility Status
    1. Eligible: subject meets protocol criteria and is eligible to participate on study
    2. Not Eligible: subject does not meet criteria and is not eligible to participate on study (screen failure)
    3. Eligible (O): subject does not meet every criteria, but a protocol exception has been obtained per PI, Sponsor, and IRB to allow subject to participate on study
  3. Verified By: coordinator who confirms subject eligibility
  4. Version Date: version of the protocol under which the subject consented
3. Click “Submit” and “Close.” Subject Status in the Subject Console header will change to “ELIGIBLE.”
4. IF APPLICABLE - If a patient decides to withdraw from study at the ELIGIBLE tab (as in, you have not entered anything in the “On Study” tab yet)
  1. Select from the dropdown for “Reason Withdrawn”
  2. Choose an appropriate selection
  3. In the “Comments Section”, please enter in the appropriate date and explanation
  4. Click on “Submit”
If the subject is Eligible, proceed to the On Study vertical tab
1. Click Update
2. Enter the following required fields into the “Subject On Study Update” block
  1. Sequence No.
    1. If the Participant ID (name of the field in Epic) is entered directly into Epic, it will be overwritten by the Sequence Number in OnCore when the protocol is linked via RPE and a Sequence Number and On Study date is entered into OnCore.
    2. If the Sequence No. needs to be updated, email oncore@wustl.edu as the update will not automatically send to Epic. The OnCore Team will manually send the update to Epic.
  2. On Study Date
  3. Disease Site (Oncology protocols only)
    1. if appropriate disease site is not available, click the blue “view all” link at the top of the dropdown menu.
    2. See our troubleshooting article about what to do if you get an error message here
  4. Oncology Group ‐ This list will auto-populate from the PC Console > Main > Management Tab > Oncology Group (entered by Regulatory coordinator)
  5. Primary and Secondary Diagnosis (non-Oncology protocols only) should not be entered.
3. For protocols in the Oncology library: Add the following required roles & their corresponding Staff Names in the “Subject Staff” block. (For Non-Oncology protocols, check with your department to see if any subject staff roles are required)
  1. Registering Coordinator- coordinator that completes eligibility items for study
  2. Treating Physician- Doctor that completes office visits and assigns treatment to the patient
  3. Registering Investigator- Investigator that identifies the patient for study
4. Click “Submit” and “Close.” Subject status in the Subject Console header will change to “ON STUDY”
IF APPLICABLE - If a patient decides to withdraw from study before anticipated off‐study or off‐treatment date, please refer to the section for “Updating Subject Statuses”, and reference “To Enter Off Study”

To Enter a Screen Fail

Begin on Home Page > Subjects menu >CRA Console
Select a protocol by entering the protocol number in the Select Protocol field
Find Subject and Click on “Epic MRN hyperlink”
Click the Eligibility Vertical Tab
1. Click "Update"
2. Enter the following fields into the “New Subject Eligibility” block
  1. Version Date: version of the protocol under which the subject consented
  2. Verified By: coordinator who confirms subject eligibility
  3. Status Date: date that the subject is found to be eligible
  4. Eligibility Status
    1. Eligible: subject meets protocol criteria and is eligible to participate on study
    2. Not Eligible: subject does not meet criteria and is not eligible to participate on study (screen failure)
    3. Eligible (O): subject does not meet every criteria, but a protocol exception has been obtained per PI, Sponsor, and IRB to allow subject to participate on study
  5. Enter “Reason Not Eligible”
3. Click “Submit” and “Close.” Subject Status in the Subject Console header will change to “NOT ELIGIBLE.”
4. IMPORTANT NOTE: if you plan to re-screen this subject, please see section below on enrolling previously screen failed subjects

To Enroll a Previously Screen Failed Subject

Applies to subjects that were consented and determined ineligible at first, that then sign consent at a later date and go through screening again to determine eligibility

Check that your protocol allows for "Duplicate Enrollment".
1. Even if a subject was only consented and then screenfailed, OnCore will consider adding the patient again as a duplicate enrollment.
2. Go to PC Console > Management Tab
3. If your study does not allow duplicate enrollment, talk to your supervisor or regulatory coordinator to modify this setting.
4. If your study is set to Yes, Follow the workflow for new subject registration
  1. When you attempt to add this subject again, you will receive a pop-up notification to verify you want to add an existing patient again
  2. You will Click Continue and complete a new registration
  3. Enter a consent for the subject.
  4. Enter the new eligibility status and continue the typical workflow for the subject.

*Institutional required fields marked in red, bold font