Subject entered forms are forms which can be self-completed by the subject (ePRO). See the specification page to see if this feature is enabled and information on email templates, reminders and information shown to subjects when logging in.
Subjects must be invited to complete their forms by completing a subject invitation form. To do this the subject must be selected from the subject list and the Invite subject to complete forms link used. This link will only be shown to investigators and not administrators or other roles as it leads to a page that potentially contains personally identifiable information (subject email and, optionally, mobile number).
Completing the subject invitation form enrols the subject and allows them to complete certain forms themselves. The form to invite the subject requires their personal email address and, optionally, mobile number. These fields are stored in an encrypted format in the database. Invitations and reminders will be sent by email and also by SMS if a mobile number is given. Unique links to complete forms online are included in both emails and SMS messages. These links expire after a set time period which is configurable for a study. Links can be turned off so that notification emails and texts act as simple reminders to complete paper forms. The number of reminders sent if forms are not completed and time delay between reminders is also configurable for a study. These details can be viewed on the specification page.
An optional memorable word can be entered which will be required by the subject to enter their forms. The time of day at which automatic invites and reminders will be sent can also be customised for each subject. Deactivating a profile prevents further invitations and reminders from being sent and subjects will not be able to enter forms, even using an unexpired link.
Once the subject invitation form has been completed the invite schedule is displayed. This shows when invites and reminders will be automatically sent. It shows whether a subject has logged in and how many forms they have completed. If a subject completes all forms due at the visit any remaining reminders will be cancelled. Links are provided to manually trigger invitations, which is useful to invite a particular subject earlier or later than scheduled. The invite schedule can be viewed by administrators but links for manual invitations are not displayed.
Note that invitations are still sent out and forms can be entered by subjects for visits that have been marked as missing.
Subjects with an active invitation to complete forms are denoted by a green icon of a person in the status column of the subject list. Subject entered forms are also shown with this icon in the subject details section.
A subject invitation report is available to administrators. This shows for each invited subject when each visit is due, whether the subject has logged in and the number of forms they have completed out of the total due.
Once a subject goes to the URL in their email or SMS invitation they will see a welcome screen. This will include a field to enter their memorable word if one has been set. The welcome message shown is configurable to show trial specific information to participants.
After the welcome screen, subjects will see a list of forms to complete. Clicking on the name of the form takes them to that form where they can complete their answers. Unlike data entry of forms by investigator and administrator accounts, subjects cannot override the validation checks on fields. They also will not see the review step - once they press the save button the form is saved immediately and cannot be viewed or edited by the subject. Entered forms are shown as completed in the list of forms.
The subject can return to complete the forms at any time until the unique link in their email expires. Once all the forms are completed a thank you message is displayed.
If the subject logs out they will see a finished message.
In addition to the security measures applied to all Sealed Envelope systems the following aspects apply to subject entered data: