TABLE OF CONTENTS

Adding Consented Subjects

These instructions are for registering subjects to a Washington University or Barnes Jewish Hospital site to count toward the Research Center accrual. For registering subjects to an external site participating on the protocol, please see Adding External Subjects below.

Begin on Home Page > Subjects menu > CRA Console
Select a protocol by entering the protocol number in the Select Protocol field
Click the Register Subject Vertical Tab
1. If the subject has an Epic MRN (i.e. they are a patient at a WashU/BJC affiliated hospital), they should be searchable in OnCore.
  1. If you cannot locate the correct patient, reference our Troubleshooting Article for search tips.
  2. If the subject is a healthy volunteer and did not consent to have their participation in the study appear in Epic, they will need to be manually registered.
  3. If the subject is not a patient at a WashU/BJC affiliated hospital and does not need to be in Epic, they will need to be manually registered (see bottom of the page).
2. In the Find Subject block enter the following fields:
  1. Study Site* (required)
  2. Last Name and Birth Date -or- MRN
  3. Click Find
3. Patient will be listed in the Results block. Click their Epic MRN hyperlink to auto populate fields in the Subject Details block.
4. Click Add
Subject Added
Click the Consent Vertical Tab
1. Enter Signed Date
2. Click Select Consents
3. On the Available Consents list, choose the Accepted radio button next to signed Consents (Review version date, approved date, and expiration date to ensure they match the signed consent)
  1. IF APPLICABLE - If a patient decides to WITHDRAW or REFUSE the consent at this point of the study:
    1. In the Other Consent Status block, select the dropdown for Status
    2. Select the appropriate option:
      1. Consent Refused
      2. Consent Waived
      3. Withdrawn
    3. Enter Status Date
    4. Click Submit
4. Click Save, and Submit. Subject status in the Subject Console header will change to Consented. Click Close.
5. Consents must be entered within 24 hours of the subject signing unless the study has no billing risk.

Stop until Subject Eligibility is Determined

If your subject is Eligible, proceed to the Enrolling Eligible Subjects work flow.
If your subject is Ineligible, proceed to the Entering Screen Fails work flow.
Incorrect Dates Entered

If you inadvertently transcribe an incorrect date for one of the subject updates (date of consent, date on study, date on treatment, etc) please contact the OST to manually push the information once you have corrected it.

Adding External Subjects

Fill out the OnCore External Patient Registration Form and email to OnCore Support Team at oncore@wustl.edu
Subject will be added to the OnCore system within the protocol requested and will be given an Epic MRN number that begins with "EYear-NN" (for example, E2018-01)
Once the OnCore team notifies you the subject has been added
Navigate to the Protocol → CRA Console and click on the external subject's Epic MRN.
Proceed to Step 5 of Adding Consented Subjects above.

Adding a Transfer Subject

Adding transfer info in OnCore, allows a subject who has transferred to our site from another site (where they started on a study) to be captured in OnCore, without counting towards our site's accrual. The transfer date should be added to discount that subject from the accrual counts for our site as well as note the day this subject started receiving treatment at our site.

To Enter a Transfer Subject:

Home Page > Subjects Menu > Subject Console
Enter subject name in the Switch Subject field
Click the On Study vertical tab
Click Update
Enter the Transferred From Site
1. Where the subject was previously enrolled on the protocol before transferring to the current study site. Click the browse box to select a study site.
Enter the Transferred From Date
1. The date a subject who was enrolled on the protocol at another study site transferred from that study site to the current study site. When this field is populated, the subject will not be reported on the Data Table 3 and Data Table 4 reports or the CTRP Accrual Report.
Click Submit and Close

*Institutional required fields marked in red, bold font

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