Updating Subject Statuses

1. Begin on the Home Page > Subjects menu > CRA console
   1. Select a protocol by entering the protocol number in the Select Protocol field.
   2. Find subject and click on subject Epic MRN hyperlink.
   3. Status Options: Consented, Eligible/ Not Eligible, On Study, On Treatment, On Follow Up, Off Study
      
      1. To update a subject's status to On Treatment
         1. Click the Treatment vertical tab
            
            1. Click Add
               1. Enter the following Required fields:
                  • Arm (The appropriate treatment arm of the protocol for which the subject will receive treatment)
                    
                  • On Arm Date (The date the subject is placed on the specific arm. This is often the same date as the on study date. If a calendar has been created for the protocol, the subject's calendar will populate according to the arm selected and planned dates will be relative to the one entered.)
                  • For treatment studies, enter the On Treatment date (Enter the date the subject begins treatment. If a calendar has been created for the protocol, planned dates on the subject's calendar will be relative to the date entered.)
               2. Click Save: the subject's status will now be On Treatment
               
      2. To update a subject's status to Off Treatment Arm date:
         1. Click the Treatment vertical tab
            1. Click Edit
               1. Enter the Off Arm Date (The date the subject goes off of the study arm.  If the subject does not go onto another study arm, this field is not required).
               2. Click Save
      3. To add a Reconsent to a subject's record:
         1. Click the Consent Tab
            1. Enter the Signed Date (The date the subject signed the consent document. This must be entered into OnCore the same day that the document was signed.)
            2. Click the Select Consents (In the "existing consents" block, the list of consents the subject has signed for the study will be listed.) 
            3. On the available consents list, choose the "Accepted" radio button next to the signed Consent (Review the version date, approved date, and expiration date to ensure that they match the signed consent.)
            4. Click Accepted, Save, and Submit.
      4. To indicate that a Reconsent is not required for a subject with an RR superscript on their MRN in the CRA Console tab
         1. Click on their MRN from the CRA Console.
            
         2. Navigate to the Consent tab and click Update.
         3. Click the hyperlinked Consent.
            
         4. In the pop-up, check the Not Applicable box and press Submit.
            
         5. This will clear the RR superscript from the subject's MRN in the CRA Console.
            
      5. To Withdraw a consent:
         1. There are several places within the Subject Console to document subject withdrawal.  
            1. How you document withdrawal in OnCore depends on the subject status during the time of withdrawal.  
            2. Since OnCore is interfaced with both the Billing Matrix and Epic, it is important to document withdrawals properly to ensure an accurate feed of information to these systems.
         2. For subjects that DO NOT have an On Study Date in OnCore:
            1. Click the Consent tab.
            2. In the Other Consent Status block enter the following fields:
            1. 1. For Status, select Withdrawn from the drop-down.
               2. For Status Date, enter the date the subject withdrew consent.
               3. In the Comments block, enter the reason for withdrawal (optional free text field).
            2. Click Submit; the subject status will change to Withdrawn
         3. For subjects that DO have an On Study Date in OnCore:
            
            1. Click the Follow-Up tab.
            2. In the Subject Off Study Update block, enter the following fields:
               1. For Off Study Date, enter the date the subject withdrew consent.
               2. For Off Study Reason, select Participant Withdrawal.
            3. Click Submit; the subject status will change to Off Study
            
      6. To enter Off Treatment date: (The date that the subject stops treatment. If a calendar has been created for the protocol, this status can be a trigger for visits in the subject calendar.)
         1. Click the Follow-Up tab.
         2. Click Update
         3. Enter the following fields into the Subject Off Treatment Update block:
            1. Off Treatment Date
            2. Off Treatment Reason (Click the drop down box and select the applicable off treatment reason. If the subject is off treatment due to progression, enter the Date of Progression in the Best Response block at the bottom of the page.)  
         4. Click Submit and Close; the subject status will change to Off Treatment
      7. To enter On Follow-Up date: (The date the subject entered the follow-up portion of the study. Entering the date activates the Follow-up visits on the subject's calendar and will disable treatment visits.)
         1. There is an option in the PC Console > Management tab to "Populate On Follow-Up Date with Off Treatment Date".  
            1. When this is checked, the Follow-Up Start Date on the Subject Console > Follow-Up tab will automatically populate with the Off Treatment Date on the same tab. 
            2. The Follow-Up Start Date can be removed or modified if needed. 
               
         2. If Follow-Up Start Date is not auto-populated for your protocol:
            1. Click the Follow-Up tab
            2. Click Update
            3. Enter the following fields into the Subject Follow-Up Update block
               1. Follow-Up Start Date
               2. Enter Date of Progression if applicable
            4. Click Submit and Close; the subject status will change to On Follow-Up.
               
      8. To indicate a subject whose follow-up site is different from the site where treatment was administered:
         1. Enter a Transferred To (Study Site) - This is the study site where the subject will be seen for follow-up visits. Click the browse box to select a study site; the list will only include study sites to which the user has access.
         2. Enter a Transferred To Date - The date a subject transferred for follow-up to a study site other than the one where treatment was administered. 
      9. To enter Off Study Date: (The date the subject went completely off study.)
         1. Click the Follow-Up tab
         2. Click Update
         3. Enter the following fields into the Subject Off Study Update block:
            1. Off Study Date
            2. Off Study Reason (Click the drop down box and select the applicable off study reason.)
         4. Click Submit and Close; the subject status will change to Off Study.
      10. To update a subject record to Expired:
          1. For WashU/BJC patients in Epic, update the patient's Epic record by either of the following methods:
             1. Notify a member of the clinical team that has access to enter the expiration date in the patient's Epic record.
             2. Email clinicaloperations@wusm.wustl.edu and include the patient's MRN and expiration date.
             3. After the expiration date is in Epic, this date will feed to the subject's Demographics tab in OnCore.
          2. For subjects that are not in Epic, update in OnCore by emailing the OnCore Support Team at oncore@wustl.edu.
             1. Include the subject MRN (from Demographics tab in OnCore) and the date of expiration.
             2. The OnCore Support Team will enter the expiration date directly into the Demographics tab of the Subject Console.
          3. Once the Expired Date is populated in the Demographics tab of the Subject Console, this will also update the following fields in the Subject Console:
             1. Expired Date in the subject's Follow-Up tab.
             2. If the subject status was On Study, On Treatment, Off Treatment or On Follow Up:
                1. the Off Study date will update to the expired date 
                2. the Off Study Reason will update to Death. 
          4. Expiration dates will flow to all of the subject's protocols in OnCore.
          5. Subjects with an expiration date will have an (Expired) appendage to their subject status on all protocols and will have a status of Expired in the Subject Search.
      11. To update subject Demographics:
          1. For WashU/BJC patients in Epic, please open a Service Now ticket by either method below:
             1. email Centralized Identity Management (Enterprise_MPI_Maintenance@bjc.org) 
             2. call 314-362-4700 (option #6) 
             3. Please do NOT indicate that this is an OnCore issue, but the information needs to be updated in Epic. You'll have to provide the patient's MRN number in the Patient Information section of the Service Now ticket and inform them of the expiration date. Once the expiration date has been entered in Epic, the demographic information should automatically flow over to OnCore.
          2. For subjects that are not in Epic, email the update to the OnCore Support Team at oncore@wustl.edu.

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