Enrolling Eligible Subjects and Entering Screen Fails
- 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”
To Enroll a Subject
- Click the Eligibility Vertical Tab
- Click “Update”
- Enter the following fields into the “New Subject Eligibility” block:
- Version Date
- Eligibility Status
- Verified By
- Status Date
- Click “Submit” and “Close.” Subject Status in the Subject Console header will change to “ELIGIBLE.”
- 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)
- Select from the dropdown for “Reason Withdrawn”
- Choose an appropriate selection
- In the “Comments Section”, please enter in the appropriate date and explanation
- Click on “Submit”
- 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)
- Click “Update”
- Click the On Study vertical tab
- Click Update
- Enter the following required fields into the “Subject On Study Update” block
- Sequence No.
- On Study Date
- Disease Site (if appropriate option not available, click the blue “view all” link at the top of the dropdown menu)
- Oncology Group ‐ Study Site
- Add the following required Roles & their corresponding Staff Names in the “Subject Staff” block
- Registering Coordinator
- Treating Physician
- Registering Physician
- 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”
- 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
- Tab 3: Click the Eligibility Vertical Tab
- Click "Update"
- Enter the following fields into the “New Subject Eligibility” block
- Status Date
- Eligibility Status
- Enter “Reason Not Eligible”
- Click “Submit” and “Close.” Subject Status in the Subject Console header will change to “NOT ELIGIBLE.”
*Institutional required fields marked in red, bold font