Participants

Participant/randomisation records can be viewed by clicking on the Participants/Randomisations link in the top menu (this may be also labelled Patients, Subjects or similar depending on your system). This shows a list of all participants entered/randomised into the study to date.

Viewing an individual participant record

Viewing a randomisation in a randomisation-only application

If there is a randomisation form in your application, the list of participants will include a column showing the randomisation group or kit codes (depending on whether your system is unblinded or blinded).

The participant list also includes a status column that can show the following symbols:

Green icon of person: participant has an active invitation to complete subject-entered forms
Amber question mark: participant has open queries
Red warning triangle: participant was randomised in error
Eye icon: participant's allocation has been unblinded

Adding participants

New participants may be added to the list at any time by clicking on the Add a participant link in the top menu. This opens the study entry form, which collects participant details according to the study requirements. Note that at least one site must be created before any participants can be added.

Alternatively, some trials may be configured such that new participants are randomised into the trial. If this is the case, participants can be added via the Randomise link in the top menu.

Deleting participants

Participants may be deleted by administrative users provided the Subject delete setting is enabled. A Delete link is shown in the 'Participant details' section. The user will be asked to confirm they wish to go ahead. Deleting the participant will also delete all associated forms and queries. This cannot be undone, so administrators should think carefully before deleting.

Searching

The search box filters the participant list to match the entered terms. Note that form data is not searched. Multiple search terms narrow the focus, e.g. 1 2 finds rows that match 1 and 2. Putting search terms in brackets performs a wider search for any matches, e.g. (1, 2, 3) or (1 2 3) finds rows that match 1 or 2 or 3.

Participant details

Clicking on a participant in the list shows participant details from the study entry or randomisation form, any queries, and provides links to add, view and edit the forms for that participant grouped by visit.

Schedule

For visits at specific timepoints (for instance 30 days after study entry), the due date is shown. Overdue forms are highlighted in red. If the Date of withdrawal has been completed, then any visits due after the date of withdrawal will become inaccessible. Forms that were completed before the date of withdrawal will remain accessible and may be viewed and edited in the normal way.

Overdue forms and a follow-up visit due after participant withdrew

Forms not available

Forms may not be available until certain conditions are met. For instance, the randomisation form may not be available until the screening visit is completed and the eligibility criteria met. You can see which forms are not available both on the overdue forms page (if the visit has a time-point), and in the 'Forms not available' report.

Report showing forms that are currently unavailable

Missing forms

Sometimes forms within a visit are not available because, for instance, the participant did not attend a follow-up appointment, the data was not collected or was lost. Forms within visits can be marked as missing using the Mark as data missing links. Marking the data as missing in this way causes all uncompleted forms in the visit to become inaccessible, and they will not be shown as overdue. Forms that were completed before a visit was marked as missing will remain accessible and may be viewed and edited in the normal way.

A follow-up visit marked as missing

Subject-entered forms (ePRO)

A 'Participant invitations' section may be displayed to invite the participant to self-complete some forms in the CRF if subject-entered forms are enabled.

Form status

A green tick next to a form name indicates that it has been marked as validated. An amber question mark symbol next to a form name indicates that the form has an open query.