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      eCOA Data Change Requests (DCRs)
      • 27 Sep 2024
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      eCOA Data Change Requests (DCRs)

      • 更新日 27 Sep 2024
      • 2 読む分
      • 印刷する
      • 闇
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      記事の要約

      DCR Process

      Site personnel can submit Data Change Requests (DCRs) through StudyWorks’ DCR Management Dashboard. StudyWorks generates a 10-digit DCR number (SW00XXXXXX) to track the request, document the cause of the data discrepancy, the incorrect values to be updated, and the reason for the change. The DCR is also linked to Clario data in the study archive.

      Once submitted, Clario personnel review the DCR. They either draft resolution steps or query the Site for additional information or clarification. If the request is clear and complete, the same team member may process the change, setting the DCR to ‘Ready for QC’ or ‘Ready for Entry’ for another Clario staff member to handle. The DCR is then independently verified by different Clario personnel. Once implemented and verified, Clario notifies the Site via email, prompting them to review the updated data in StudyWorks.

      Information Scope

      Solution: eCOA

      Platform: StudyWorks

      Frequently Asked Questions              

      What should I do before I create a DCR?

      Before creating a DCR, ensure the data correction is valid, is not preventing the participant from entering data or viewing a questionnaire, and does not require urgent care.

      What’s the difference between an urgent DCR and a standard DCR?

      Initiate urgent DCRs by phone with Clario Customer Care when a participant is at the site and unable to enter data or proceed due to a data issue. Clario’s Data Coordination team prioritizes and resolves urgent DCRs as quickly as possible.

      How do I create a non-urgent DCR?

      1. Click DCRs on the StudyWorks Subject Management Dashboard.

      2. Click Create DCR on the DCR Management Dashboard.

      3. Complete the online form to the best of your knowledge and press Submit.

      Read more about creating DCRs.

      How do I create an urgent DCR?

      Where does my DCR go?

      All DCRs submitted are processed by Clario’s Data Coordination team.

      After I create a DCR, what do I need to do?

      Monitor your DCR’s progress from the DCR Management Dashboard in StudyWorks. Take action on any DCRs displayed in your Inbox.  

      How can I check the status of my DCR?

      Use the DCR Management Dashboard in StudyWorks to quickly search for and identify your DCR’s status. Remember that you’ll receive automated email notifications when a DCR requires your attention.

      How can I see if my site has any open DCRs or DCR actions?

      All DCRs requiring your attention will be displayed in the Inbox on the DCR Management Dashboard in StudyWorks. You can also view all open DCRs by selecting All Open in the DCR Management Dashboard.

      Why is there a Query posted to the site on an open DCR?

      If a submitted DCR is missing crucial information or contains a typographical error affecting its processing, Clario personnel will post a query requesting the updated information. You will then receive an email notification indicating that you have a query to address.

      Does Clario save the data both before and after the DCR is processed?

      Yes, all DCR resolution data is captured in Clario’s Site archive. You can also review the form-level and DCR-specific audit trails to find this information.

      What do the different DCR status levels mean?

      You’ll find the full explanation of DCR statuses and their categorization here.

      How can I close a DCR that I no longer need?

      You can cancel DCRs in a Submitted status by contacting Clario Customer Care or your study-specific Clario representative.

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