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  1. Begin on Home Page > Subjects menu >CRA Console

  2. Select a protocol by entering the protocol number in the Select Protocol field

  3. Find Subject and Click on Epic MRN hyperlink

To Enroll a Subject

  1. 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 Select from the dropdown for “Reason Withdrawn”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
  1. Click the On Study vertical tab
  2. Click Update
  3. Enter the following required fields into the “Subject On Study Update” block
    1. Sequence No.
    2. On Study Date
    3. Disease Site (if appropriate option not available, click the blue “view all” link at the top of the dropdown menu)
    4. See our troubleshooting article about what to do if you get an error message here
    5. Oncology Group ‐ This list will auto-populate from the PC Console > Main > Management Tab > Oncology Group (entered by Regulatory coordinator)
  4. Add the following required roles & their corresponding Staff Names in the “Subject Staff” block
    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 Physician- Doctor that identifies the patient for study
  5. Click “Submit” and “Close.” Subject status in the Subject Console header will change to “ON STUDY”
    1. 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

  1. 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. Verified By: coordinator who confirms subject eligibility
      6. 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

  1. 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.