Participant statuses track where each participant stands in your EDC studies, from screening through to completion. They are not only labels: automated features such as ePRO reminders read the status to decide whether to keep sending messages.
What they are for
Everyone on the study team reads the same progress labels, for example Screening, Active, Completed.
Automations use the status to know when to stop. Giving a participant a status with Stop follow-up, such as Withdrawn or Screen failure, stops future ePRO messages and reminders, so nobody who has left the study keeps hearing from you.
A participant's status is changed by hand, from the participant profile. It cannot be changed from the inclusions list. You find it:
in the inclusions list, in the Participant status column, as a colored chip next to the participant ID. Its filter lets you pick several statuses, or No status.
in Subject Management, in both list and detail view, and at the top of each eCRF.
in the eCRF study, single record, ePRO records and reports exports, in the PARTICIPANT STATUS column.
The former Status column, which reflects the eCRF progress, is now called eCRF status in the inclusions list, its filter and the exports, so the two are no longer mixed up.
The fields on every status
Field | What it does |
Status name | The name shown in the app, for example Active or Withdrawn. |
Color | The color of the status chip, for example in the inclusions list. |
Stop follow-up | When turned on, stops all ePRO sending, reminders and automations for the participant who gets this status. |
Mark as a default status | Applied automatically to every new participant. Only one status can be the default. |
How to set them up
Since release 4.24.6, you create and manage participant statuses yourself, in Settings > EDC > Participant statuses. You need the Participant statuses permission: Edit to create and change statuses.
đ ď¸ Step by step guide
Go to Settings > EDC > Participant statuses.
Click New status.
Enter a Status name (for example Screening, Active, Withdrawn, Completed) and pick a Color.
Turn on Stop follow-up if this status means the participant has left the study.
Turn on Mark as a default status if new participants should get this status automatically.
Click Save.
To change the order, drag a status up or down the list. To edit or archive a status, use the icons at the end of its row.
đĄ Tip: if you run an ePRO study, make sure at least one status has Stop follow-up turned on. Without one, you have no way to stop messages reaching somebody who has withdrawn.
Good to know before you start
â ď¸ Warning: points worth planning around.
Statuses are set at instance level, so they are identical across every study on your platform. A status list that suits one study has to suit all of them.
Archiving cannot be undone from the interface. An archived status can no longer be given to participants, but participants who already have it keep it. If you archive the default status, new participants have no status until you set a new default.
Renaming a status changes it everywhere, including on past records. Status names are displayed as entered and are not translated.
Export columns changed in release 4.24.6: STATUS is now ECRF STATUS, and a new PARTICIPANT STATUS column is added right after it. If you process your exports automatically, check anything that relies on column names or positions.
Recruitment and EDC statuses are not yet synchronized. A status on one side does not follow to the other.