A study team member with PII rights can withdraw a participant from the participant list. This article outlines the steps necessary to withdraw a participant securely and update the study records accordingly.

1. To mark a participant as withdrawn, start by navigating to the ‘Participants’ listing. 

2. Locate the participant you wish to mark as withdrawn, then click on the three-dot context menu in the Options column. 

3. From the dropdown menu, select the 'Mark as withdrawn' option. This will securely mark the participant as withdrawn.

4. In a new pop-up window select a date of withdrawal. This date is then also included in the Audit Trail Event that is logged.

5. Select the reason for withdrawal. If you select ‘Other’ it will allows you to provide a custom reason in a text field.

6. Decide to send an automatic confirmation email to the participant after the withdrawal is processed.

7. To save or cancel changes use the relevant buttons - ‘Mark as withdrawn’ or ‘Cancel’ - at the bottom.

8. Withdrawn participants are hidden from the participant overview by default. They can be shown by turning on the Include withdrawn’ in the filter menu.

9. The consent status of the participant changes to 'Withdrawn' when they are withdrawn from the study.

10. A study team member with PII rights can undo the withdrawal of a participant. To undo participant withdrawal, locate the withdrawn participant, click on the context menu (three dots) and choose ‘Unmark as withdrawn’ option:

11. Then confirm by selecting the ‘Unmark as withdrawn’ button.

12. An Audit Trail Event will be logged to document this change. 

13.The study status will change back to the original status of the participant and the restricted access is removed from theAfter being withdrawn, participants have the same type of access as archived participants. They can view the study, their documents and their participant details. However, they can not change anything or sign any documents.

14. An active participant can either be withdrawn or archived. After withdrawing, a participant can not be archived anymore and vice versa.

15.When withdrawing a participant record with a LAR attached to it, the study team member will be asked if the LAR should be notified instead of the participant.