Creating a DCR in StudyWorks

Creating eCOA DCRs in StudyWorks

Click DCRs on the StudyWorks Subject Management Dashboard.
Click Create DCR on the DCR Management Dashboard.
Select the target Site, Subject, and Reason to change using the drop-down menus.
Write an effective Description by including all relevant information (e.g., dates, visit numbers/labels, questionnaire names, values requiring edits, etc.).
Click the most appropriate action button (i.e., Submit, Submit and Edit Copy, or Submit and Add Attachments).
Enter your login credentials. Review the affidavit. Then click inside the empty checkbox and press Sign.
StudyWorks confirms the successful submission.
Don't worry when you don't see the DCR displayed in the table. Click All to view all of the DCRs and then search for the DCR Number (e.g., "SW00029984").

Information Scope

Solution: eCOA

Platform: StudyWorks

Important Reminders

A DCR is requested for a single subject. If multiple subjects are affected, repeat the process for each one.

Contact Clario Customer Care for urgent Data Change Requests that prevent the subject from continuing in the study.

The key information you’ll need to enter into the DCRs Description:

The date the subject stopped participating in the clinical trial.
The reason the subject stopped participating (e.g., “Screen Failure”, “Early Terminated the Study”, “Successfully Terminated the Study”, etc.).

Clinical data forms may be referred to as “diaries”, “assessments”, or “questionnaires”. Follow this guidance when requesting form updates.

Identify the information that needs to be changed such as the date or year of birth, assignment date, etc.