Subject records can be viewed by clicking on the Subjects link in the top menu (this may be labelled Randomisations, Participants or similar depending on your system). This shows a list of all subjects entered into the study to date. An amber question mark in the status column of the subject listing indicates that there is an open query for that subject.
Viewing an individual subject record
New subjects may be added to the list at any time by clicking on the Add a subject link in the top menu. This opens the study entry form which requests a subject identifier and date of study entry. Note that at least one site must be created before any subjects can be added.
Some trials may be configured such that subjects are randomised into the trial. If this is the case a subject can be added via the Randomise link in the top menu. Check the specification page to see if this is the case.
Subjects may be deleted by administrative users providing the delete subject setting is enabled. A delete subject option is shown in the ‘Subject details’ section. The user will be asked to confirm they wish to go ahead. Deleting the subject will also delete all associated forms and queries. This cannot be undone so administrators should think carefully before deleting.
The search box filters the subject 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.
Clicking on a subject in the list shows subject details from the study entry form, any queries and provides links to add, view and edit the forms for that subject grouped by visit.
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 If the Withdrawal form has been completed and the subject marked as withdrawn from follow-up, then any visits due after the date of withdrawal will not be shown as overdue. All uncompleted forms in these visits will become inaccessible. Forms that were completed before the subject was marked as withdrawn will remain accessible and may be viewed and edited in the normal way.
Overdue forms and a follow-up visit due after subject withdrew
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
Sometimes forms within a visit are not available because, for instance, the subject 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
A subject invitations section may be displayed to invite the subject to self-complete some forms in the CRF if subject entered forms are enabled.
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.