eConsent guide

Our eConsent facility allows your participants to provide consent remotely. The facility is part of the Red Pill database (our EDC system).

The eConsent process generally involves the following steps:

• Participant registration
• Invitation to complete consent form
• Completion of consent form by participant
• Investigator sign-off
• Generation of secure PDF record

However, these steps can be tailored to the requirements of your trial.

In order for us to design your eConsent system, you will need to complete an e-consent registration form specifying all your requirements.

1 Participant registration

First of all, your participant needs to be registered in the study database (Red Pill). This can be done in two different ways: public or manual registration.

• Public registration: participants register themselves and can complete the consent form straight away (no invitation from site staff is required).
• Manual registration: site staff register participants manually and subsequently invite them via email or SMS to complete the consent form.

Public registration

If you choose to have public registration, you can share a public registration link with your target participants using a static web address (e.g. your trial website). Anyone with the link can sign up.

The link leads to a registration form in the study database where the participant enters their email address and other details.

The registration form can be designed to collect any required information. For example, in the above example, a check on the date of birth is included to ensure the participant is aged 18 or over.

The participant's email address is always collected, as it will be used to send a unique link to the consent form and a PDF copy of the signed consent form.

An optional mobile phone number allows the link to be sent by SMS as well as email (charges apply). An optional SMS code authenticates the phone number provided and prevents duplicate sign-ups.

The email and mobile phone number fields are stored in an encrypted format in the database.

Participants can also select their own site, and optionally, recruitment quotas (overall or per site) can also be specified.

Once the registration form is saved, the participant is registered and given a unique ID. The start screen is then shown to the participant with customisable wording. Clicking on the Start button takes the participant to the consent form to be completed.

An email is also sent to the participant to confirm registration and provides a unique link for them to get back to the start screen later if necessary.

Manual registration

In manual registration, staff with investigator accounts log into the study database and add the participant by clicking on the 'Add participant' link (or similar) and completing the registration form.

This will create a record for the participant, who is then ready to be invited to complete the consent form.

Manual registration is also possible in trials with public registration, as site staff can optionally register participants manually.

2 Inviting participants to consent

After being registered by site staff, participants need to be invited to consent. In order to do this, site staff need to complete a participant invitation form.

To invite a participant to complete eConsent, they must be selected from the participant list. This list shows the eConsent status. Participants who have not yet been invited to complete eConsent are shown as 'Enrolled'

Once the enrolled participant is selected, the user needs to click on the Invite link. This link will only be shown to users with investigator accounts (i.e. site staff), and not administrators or other roles, as it leads to a form that collects personally identifiable information (i.e. participant email and, optionally, mobile number).

Optionally, site staff may also have the possibility to skip the eConsent process and complete a "Paper consent" form to indicate that the participant provided consent on paper - this paper consent step is optional and can be added at customer request.

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.

Once the participant invitation form is completed, the eConsent status will change to "Invited".

Completing the participant invitation form will automatically send an email invite to the participant with a link to complete the consent form.

In trials with public registration, investigators can also manually invite participants to complete the consent form. However, in this case, the invitation to complete the consent form is not sent automatically and needs to be sent manually.

Invitation and reminders

Invitations and reminders will be sent by email, and also by SMS if a mobile number is given. A unique link to complete the consent form online is included in both emails and SMS messages. This link expires after a set time period which is configurable for a study.

The number of reminders sent if the consent form is not completed and the time delay between reminders are also configurable for a study.

These details can be viewed on the specification page.

The time of day at which the invite and reminders will be sent can be customised for each participant on the participant invitation form.

Deactivating a profile on the participant invitation form prevents reminders from being sent, and participants will not be able to enter data, even using an unexpired link.

3 Online consent form

The consent form confirms the participant’s understanding of the trial by asking questions which must be answered correctly to proceed. The form can contain links to the Participant Information Sheet and other documents.

Questions can be answered using yes/no fields, initials, checkbox, etc. Error messages are shown if the participant gives the wrong answers.

The participant must provide their name and sign using the signature panel on the form. This signature panel works with a mouse or touchscreen.

Consent PDF

On saving the form, a time stamped PDF version of the consent form is created and stored in the system.

The consent PDF contains a 'Signing information' section, which contains the server timestamp, form name, participant information such as ID, site, and email address, URL, etc.

The eConsent status of the participant will show as 'Pending review' until the eConsent form is signed off by the investigator.

The PDF of the signed consent form can optionally be sent to the participant by email as a record of their consent. The PDF is encrypted and cannot be edited.

4 Investigator interface and consent verification

The investigator at the site can see the records for each participant at this site, including the consent form. The participant details and invitations to complete forms can also be viewed. Email and/or SMS invitations can be manually resent if necessary.

In trials with public registration, investigators can use this interface to add a new participant and manually invite them to complete the consent form.

Investigator verification of consent

An optional step is for investigators to check the consent process has been followed correctly and that the participant’s identity has been checked. In this case, the investigator signs a form (e.g. 'Investigator sign-off form' or similar) stating that they have checked the consent process

The questions on this form can be customised for your trial.

Completing the investigator verification form creates a PDF of the consent form and investigator verification combined as one document that is stored in the database and can be optionally sent to the participant.

Completing this process will make the subsequent visits and forms available (if applicable). The eConsent status of the participant will show as 'Complete'.

5 Paper consent form (optional)

Optionally, if a participant does not complete the eConsent form and provides consent on paper instead, this can be indicated by the investigator completing the 'Paper consent' form. This form usually contains a simple checkbox field such as 'Consent was provided on paper' and other questions if necessary.

When this form is completed, the eConsent status of the participant will show as 'Skipped'.

Completing the paper consent form will make the subsequent visits and forms available (if applicable).

6 Restart eConsent process

If a participant has completed the eConsent process but requires a re-consent because of an error, the process can be restarted by an administrator (i.e. by default, administrators have the 'Restart or cancel the eConsent process' permission - see Editing user permissions). A Restart link is shown on the Participant details page.

Restarting the eConsent process will delete all forms (i.e. eConsent, Investigator verification) and attachments. The active invitation to the eConsent will also be cancelled. A reason needs to be entered to restart the process.

After this, the whole eConsent process can be restarted (i.e. invite participant, complete eConsent, etc).

Restarting eConsent will not affect other forms that have already been entered for that participant.

7 Multiple consent episodes (optional)

Sometimes trials might involve multiple consents. For example, an initial consent episode might be followed by a re-consent episode later on.

In this case, these are two independent consent episodes, that is, the first consent process needs to be completed in full (i.e. including the investigator consent verification step) before the re-consent process can be completed.

Therefore, the participant needs to be invited to complete the first eConsent as usual. Once this is done and the investigator consent verification form is completed, the participant can then be invited to complete the re-consent form. Again, the re-consent process will show as completed once the re-consent verification form has been added by the investigator.

PDF files will be stored in the system and sent to the participant as usual for each consent episode.