End of Study

Modified on Wed, 30 Apr at 11:53 AM

Have you successfully completed your study? Congratulations on reaching this major milestone. In this article, we would like to show you which tasks we recommend for completing the study in our software.

 

Please make sure that all signatures and lockings have been recorded and all queries have been answered or closed before taking these steps, all (S)AE events should be completed and fully signed.



 Good to know: 


If you want to first stop the "subject enrollment" prior to cleaning the data to later initiate "End of Study actions", you can assign the users with a "no enrollment" role or remove the "enrollment" right from their current role. All other rights remain, meaning data entry and updates, ePRO send out, query management, (S)AE management etc. is still available as assigned per role.



Set the status of the subjects to "completed", if not already done. To do this, click on subjects with "active" status in the status column in the subject overview. A new pop-up window opens. Select "completed" from the drop-down list. As a result, no scheduled events forms can be edited in the study anymore, no more ePRO links will be sent (planned/scheduled, reminders or manual), however, new queries and (S)AEs can still be created. Signatures and lockings can still be recorded. See detailed information about actions that can be performed based on the status in this article: Allowed actions based on statuses

Change the role of all users to "Read only" or deactivate them if they should not have access to the study anymore. To change the role, go to the second step "Access" in the editing mode of the study. Click on the respective user and change the role to "Read only" at the bottom right and save the change. Read the following article for further information: How do I set up collaborators and edit their rights? (Step 2.1)

If you have not created a "Read only" role by then, go to the "Roles" tab and create a new role. Read more in the following article: How can I set up user roles? (Step 2.2). To deactivate the users, select the respective users in the "Collaborator" tab and click on "Deactivate Collaborator" below "Actions". The status of the users will change accordingly.


Set the status of the entire study to "completed". To do this, go to the first step "General" in the settings mode of the study. As a result, signatures and lockings can no longer be recorded. Data entry is no longer possible, including enrollment of new subjects. (S)AEs and Queries could still be recorded. See detailed information about actions that can be performed based on the study status: Allowed actions based on statuses.
If your role allows export of data and/or reports, this is still possible
Use the role change described above to disable all update and creation options.



Deleting the study



If you have the authorization to delete a study, you can do this by clicking on the [...] button of the study card in the general study overview. Here you will see the "Delete" button. If you click on this button, you will be asked again for security reasons whether you are sure that you want to delete the study. Confirm your intention.




⚠️  Please note that deleting the study is final!





⚠️  Please pull all required exports (Scheduled Events, Unscheduled Events, (S)AEs, Queries, Subject Audit Trail etc.) before deleting the study. Read the following article for further information: How do I export data of my study?





✉️ Still have questions? Feel free to contact your Customer Success Manager or email us at support@climedo.de.




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