Enrolling Eligible Subjects and Entering Screen Fails
- Begin on Home Page > Hover Cursor over Subjects menu > Select CRA >CRA Console
- Select a protocol by entering the protocol number in the Select Protocol field
- Find Subject and Click on “Subject Epic MRN hyperlink”
To Enroll a Subject
- Tab 1: Click the Eligibility Vertical Tab
- Click “Update”
- Enter the following fields into the “New “New Subject Eligibility” Eligibility” block:
- Status Version Date
- Eligibility Status
- Verified By
- Version 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- Select from the dropdown for “Reason Withdrawn”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”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 work instructions, titled, 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 work instructions, titled, 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