Undo or edit a subject's completion of a study

If you marked a subject as Complete in error or an additional visit was included in the study's schedule, you can undo the action. Additionally, you can also edit a subject's study completion date.

If your study includes a Study Completion Visit with associated forms that you already completed, when you undo a subject's completion, the associated Study Completion Visit remains visible until you clear the data associated with that visit. A subject's Study Completion Visit is displayed on the Previous Visits column.

To hide the visit you must clear all of its data and close all of its associated queries. You should ensure that you clear the following data points (and not delete the data manually):
  • All data, including hidden data
  • All queries, including manual, automated, or candidate queries. If you need help closing a query, reach out to your Clinical Research Associate (CRA).
  • All data flags. Remember to clear data flags, not remove them manually by selecting the X icon next to the data flag.
Additionally, consider the following notes:

Note:

  • You cannot undo a subject's completion if the Study Completion Visit contains any frozen or locked data. When you attempt to undo a Study Completion Visit that contains frozen or locked data, an error message is displayed advising you to contact your Clinical Research Associate (CRA) to work with them for unlocking or unfreezing the data. Moreover, you don't see the option to undo a subject's event if their status is Locked overall.
  • When a subject isn't in the appropriate state, don't try to enter extra data into the Withdrawal, Completion, or Screen Failure visit, as that data might not be saved.
  1. On the Home page, determine where to work. For more information, see Access study modes and pages.
  2. Along the top, make sure Subjects is selected.
  3. Filter your view based on your desired criteria. For more information, see Filter subjects in a study.
  4. In the table, locate the subject whose completion you want to undo or edit.
    A completed subject appears with a Complete icon (Complete).
  5. If you want to undo a subject's completion of a study, do the following:
    1. From the Manage Subjects drop-down, select Undo Complete Study.
    2. On the Undo Completion dialog, do the following, from the Reason for Change drop-down, select a reason for undoing the subject's completion of the study.
    3. Select the checkbox informing you of the subject's status change and the visibility of the visit until its data is cleared.
    4. Select Undo Complete Study.
    5. If applicable, determine whether you want to clear data for a subject's Study Completion Visit.
  6. If you want to edit a subject's completion details, do the following:
    1. From the Manage Subjects drop-down, select Edit Completion.
    2. On the Edit Completion dialog, if required, update the Date of Completion.
    3. From the Reason for change drop-down, select a reason for the edits you want to make.
    4. Select Save.
    Anytime you edit a subject's study completion details, if included in the study, the Study Completion visit opens up again. You can choose to edit and save any data in the visit, or close the visit.

After you undo a subject's study completion, their state changes from Complete to the state the subject had before being completed, such as Active.

Related Topics

Parent topic: Manage subjects