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Enrolling Eligible Subjects and Entering Screen Fails

 

  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. Version Date
      2. Eligibility Status
      3. Verified By
      4. Status Date
    3. Click “Submit” and “Close.” Subject Status in the Subject Console header will change to “ELIGIBLE.”
      1. 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 Select from the dropdown for “Reason Withdrawn”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)
      1. See our troubleshooting article about what to do if you get an error message here
    4. Oncology Group ‐ Study Site
  4. Add the following required Roles  roles & their corresponding Staff Names in the “Subject Staff” block
    1. Registering Coordinator
    2. Treating Physician
    3. Registering Physician
  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. Tab 3: Click the Eligibility Vertical Tab
    1. Click "Update"
    2. Enter the following fields into the “New Subject Eligibility” block
      1. Status Date
      2. Eligibility Status
      3. Enter “Reason Not Eligible”
    3. Click “Submit” and “Close.” Subject Status in the Subject Console header will change to “NOT ELIGIBLE.”

 

 

*Institutional required fields marked in red, bold font