Undo or edit a subject's withdrawal

If you withdrew a subject in error, you can undo the action. However, if the subject was automatically withdrawn due to a code break, you can't undo the withdrawal.

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

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 withdrawal if the associated Withdrawal visit contains any frozen or locked data. When you attempt to undo a Withdrawal 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 even 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, Study Completion, or Screen Fail visit, as that data might not be saved.
  • If a subject is withdrawn due to a code break, you cannot undo the withdrawal event or edit any details of the event, such as the reason for withdrawal or the withdrawal date. The withdrawal date associated with a code break is displayed on the Subject History bar, in the Subject Events report, and the Subject dataset.
  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 the required criteria. For more information, see Filter subjects in a study.
  4. In the table, locate the subject whose withdrawal you want to undo or edit.
  5. Select the checkbox to the left of the subject.
    A withdrawn subject appears with a Withdrawn icon (Withdrawn).
  6. If you want to undo a subject's withdrawal, do the following:
    1. From the Manage Subjects drop-down, select Undo Withdrawal.
    2. On the Undo Withdrawal dialog, from the Reason for Change drop-down, select a reason for undoing the subject's withdrawal from the study.
    3. Select the checxbox informing you of the subject's status change and the visibility of the visit until its data is cleared.
    4. Select Undo Withdrawal.
    5. If applicable, determine whether you want to clear data for a subject's Withdrawal Visit.
  7. If you want to edit a subject's withdrawal details, do the following:
    1. From the Manage Subject drop-down, select Edit Withdrawal.
    2. On the Edit Withdrawal dialog, from the Reason for Withdrawal drop-down, select a different reason for for withdrawing the subject from the study, if needed.
    3. If required, update the Date of Withdrawal.
    4. From the Reason for Change drop-down, select a reason for the edits you want to make.
    5. Select Save.
    Anytime you edit a subject's withdrawal details, if included in the study, the Withdrawal 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 withdrawal, their state changes from Withdrawn to the state the subject had before being withdrawn, such as New, Enrolled, or Active.

Related Topics

Parent topic: Manage subjects