Participant-entered forms (ePRO)

Participant-entered forms are those which can be self-completed by the participant (ePRO). See the specification page to see if this feature is enabled and information on email templates, reminders and information shown to participants when logging in.

Inviting participants

Participants must be invited to complete their forms by completing a participant invitation form. To do this, the participant must be selected from the participant list and the Invite 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 (participant email and, optionally, mobile number).

Completing the invitation form enrols the participant and allows them to complete certain forms themselves. The form to invite the participant 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 participant to enter their forms. The time of day at which automatic invites and reminders will be sent can also be customised for each participant. Deactivating a profile prevents further invitations and reminders from being sent, and participants will not be able to enter forms, even using an unexpired link.

Invite schedule

Once the participant invitation form has been completed, the invite schedule is displayed. This shows when invites and reminders will be automatically sent. It shows whether a participant has logged in and how many forms they have completed. If a participant 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 participants for visits that have been marked as missing. However, if a date of withdrawal is entered, then any invitations due after this date will not be sent.

Participant list

Participants with an active invitation to complete forms are denoted by a green icon of a person in the status column of the participant list. Participant-entered forms are also shown with this icon in the participant details section.

Report

A 'Participant invitations' report is available to administrators. This shows for each invited participant when each visit is due, whether the participant has logged in and the number of forms they have completed out of the total due.

What the participant sees

Once a participant 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, participants 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, participants 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 participant. Entered forms are shown as completed in the list of forms.

The participant 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 participant logs out, they will see a 'Finished' message.

Investigators adding or editing ePRO forms

ePRO forms can be completed and edited by Investigators and other roles with CRF permissions. This is useful where a participant has completed the form on paper for instance. You must make sure that any information you add or change has been provided or authorised by the participant themselves. Regulatory authorities may ask for evidence this is true.

Testing ePRO forms

When testing ePRO forms it's best to open the invite links sent via email or SMS in a different browser or incognito/private window to the one you are using with your normal user account. This is because a cookie is set in your browser to indicate you are a participant, and this cookie prevents you logging in with your usual account. To clear this cookie visit this link.

Security

In addition to the security measures applied to all Sealed Envelope systems, the following aspects apply to subject-entered data:

• Only investigator accounts can view the participant's email address and/or mobile number
• The participant's email address and/or mobile number are encrypted at rest (AES-256 CBC)
• Participants are sent unique links to complete forms that expire after a set period
• Participants cannot view their forms, only add them. Draft saving is not enabled.
• An optional memorable word can be specified by the investigator that is used as a challenge when a participant accesses a unique link