eConsent add-on

The eConsent add-on allows you to collect consent from subjects electronically.

The eConsent add-on in SMART-TRIAL can be a powerful way of gathering consent from subjects, and for study personnel (investigators, coordinators, sponsors, monitors) to able to keep track of the progress from a central location.

Click for setup

Click for how to manage

How does it look for subjects?

NB! Please ensure eConsent, and the type currently implemented in SMART-TRIAL, is allowed and recognized by the country where the study will be conducted, BEFORE setting it up. The rules varies from country to country.

Please read our introduction to eConsent here along with linked resources in the introduction.

For use, please contact us: support@smart-trial.com

Terminology in this article:

eConsent: The process of handling signing a consent document electronically. 

Informed Consent: A process where subjects meet with an investigator and goes through the trial, with option of asking questions, prior to signing a consent document. 

Consent document: The document, that is presented to, and signed by subjects, detailing what the study entails.

Which device can be used for eConsent?
Consent can be signed by a subject from any modern device with a modern browser: Laptop, Desktop, Tablet, smartphone. 

What type of consent is this?

eSignature (draw on screen)

Validated with a One-Time-Password (OTP) sent via SMS.

First the subject signs, then the investigator.

NOTE! The eConsent add-on in SMART-TRIAL is NOT  Informed consent, but it can be a part of an informed consent process.

Brief overview of  signing process

  1. Subject receives a link to the consent document either by being sent via email/SMS or by scanning a QR code
  2. One Time Password is sent to subject to access the consent document
  3. Subject confirms they have read, understood and agreed to what is in the consent document.
  4. Subject draws or writes their signature
  5. One time password is sent to the subject to confirm the signature
  6. Investigator receives an email, that a new document is ready to be countersigned
  7. Investigator logs in, reviews the signature
  8. Investigator draws or writes their signature
  9. Investigator receives a One Time Password
  10. Document is fully signed
  11. Subject receives an email with a link to the fully signed document.

Setting up eConsent

The eConsent add-on is available for all SMART-TRIAL product types. Once enabled, three subject attributes will be automatically selected: 

 First Name, Last Name, and Mobile number

These attributes are mandatory, do not de-select them. Mobile number is mandatory due to the OTP  sent to subjects to verify their identify. Subject attributes containing personal identifiable information is hidden from collaborators without the "View Identifiable" permission.

If you wish to send the consent document to subjects via email, select email as a mandatory attribute

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To proceed with setting up eConsent in SMART-TRIAL:

  1. Create at least one form in your study 
  2. Have your consent document in PDF format ready.
  3. Create a process

Within the process there will be an extra button to add a Consent Event.button

 

After you have added the Consent Event, it has to be configured.

setup

Name: Give the event a name, or keep the default 'Consent Event'.

Activation: Cannot be altered, must be started manually by study personnel.

Where will consent be signed: Decide where the consent will be signed by the subject. This depends on the protocol.

Remote will send an email/SMS to the subject, asking them to access the consent document from their own device. The email/ SMS texts must be defined.

On-site will not send out anything. Instead the consent document can be accessed via a QR code or by sharing a link. The QR code can be scanned by the subjects own device, or an on-site tablet or similar can be used, and handed to the subject.

Consent Document: The PDF that will be presented to subjects and signed by subject and investigator. Upload the document in the study primary language (In the above screenshot the primary is English). Must be a PDF and less than 10 mb. 

PDF's for any other languages must be uploaded using 'Translations' in the left side menu.

Allow re-consent: The event becomes a 'Multiple Activation' and allows for subjects to be re-consented, in case the consent changes/is extended later. This can be enabled via amendment mode after the study has started.

Other languages

NOTE: SMART-TRIAL eConsent add-on currently supports English (that is all buttons/texts available for the subject). If you would like to use it in other languages please contact us.

This sections makes the following assumptions:

  • Translations Module is enabled under "add-ons".
  • At least one 'Other' language has been selected.
  • A process exists with a Consent Event.

To finalize the consent for other languages, use the left side menu and navigate to 'Translations':

Translation

Click on the "Process" icon, for the language where a consent document should be added:

Translate 2-1

Find the Consent Event, and then upload the PDF in the appropriate language:

Translate 3

Press the 'Save' button and repeat the process for any other languages.

After the document has been added, the setup is complete.

 

Consent versioning

The eConsent add-on in SMART-TRIAL has automatic versioning, to keep track of which consent subjects have signed throughout the study.

The version is similar to our forms, with M.N, where m is major versions and n is minor.

Building mode

During building mode, every time you upload a new PDF to the Consent Event, it will increment the minor version: 0.1 -> 0.2 ->0.3

Test Mode/ Data Collection

Upon starting a study or putting it in test mode, the consent version is set to 1.0.

Amendments

If a new consent document is uploaded during amendment mode, the minor version will again increment: 1.0 -> 1.1

But upon finishing the amendment, the version will increment the major version and reset the minor: 1.1 -> 2.0

That way all subjects enrolled after the amendment will be consented with version 2.0, do note that any subjects enrolled prior to the amendment, will still have a consent with version 1.0 available to them. They instead have the option of being re-consented.

Currently all languages has the same version, meaning it is not possible to have English version 2.0 but German version 1.0, they will both show version 2.0.


Manage consent

The eConsent add-on makes use of the following permissions:

Subject: Required to 'Start' a consent signing. 

View Identifiable: Required to view a signed consent document, as it contains PII.

Export: Required to 'Download' consent documents. Must be combined with 'View Identifiable' to download signed consent documents.

Setup Study: Required for setting up consent.

Sign eConsent: Required to countersign a consent document. Usually given to investigators.

 

Consent overview

The consent table can be found in the left side menu "eConsent".

leftside

Here all consents will be shown for processes that uses consent, and the user has permissions to view.

That means if your study has one process with two sites, but the user only has access to one site, they can only see consents for that one site. Where study coordinators/monitors/etc. can view all consents in one central location.

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NOTE: Notice how the action buttons are disabled for Queen Elizabeth in the photo, that is because Queen Elizabeth had her preferred language set to one without an associated consent document.

Status

The status column gives the status of the consent for a particular enrollment. A brief overview of the different status' and their meaning follows:

Not Started: The consent has not been started, and it is not possible for subjects to access the consent document.

StartedThe consent has been started. If it is using "remote", an email/SMS has been sent to the subject asking them to read and sign the document. If using "on-site", the consent document can now be accessed by the subject via a QR code or a link.

Subject Signed: The subject has read and signed the consent document. Anyone with the "Sign Consent" permission are now notified via email.

Fully Signed/CompletedThe consent document has been countersigned by the investigator, and the signature process is now finished.  Subject has given their consent and is ready to partake in the study (if eligibility criteria are fulfilled).

Signature is being processedThe signature is not yet ready to be shown/reviewed.  Wait a few minutes and it should be ready.

ExcludedThe excluded status is shown if a subject is excluded BEFORE the "Completed/fully signed" step. It will still be possible to see the consent document and the subject signature (if that was given), but the consent process has stopped.

CancelledThe cancelled status is shown if a subject is discontinued BEFORE the "Completed/fully signed" status is reached. It will still be possible to see the consent document and the subject signature (if that was given), but the consent process has stopped.

If a consent has reached "fully signed/completed" it will not change status to Excluded/Cancelled.

Searching & Filtering

It is possible to search for a specific subject using the search bar, or filter the table to see a sub-set of the table.

Filters can be applied by clicking the "Filter" button to the right of the table. As many filters as desired and be applied at once. 

Use it for instance to look at the "Subject Signed" status in combination with "Start Date" the past 30 days!

 

Actions in the table

The actions available depends on the status of the consent. A brief overview follows below.

view

View: Shows the specific consent document in its current state, i.e. if the subject has signed, it will be presented with the subject signature. It is also via "View" an investigator, or anyone with the "Sign Consent" permission can countersign the consent document.

start

Start: Starts the consent process, allowing the subject to access and sign the document. Will send an email/SMS if applicable, else it generates a link and QR code that can be used to access the document.

dl

Download: Downloads the consent document in its current status(with signatures if present). Note that it requires both Export and View Identifiable to download a signed consent document.

qr

QR/link: Presents a QR code and the link that can be used by subjects to access the consent document.

    reconsent

Reconsent: initiates re-consent for the subject if available on the process. Will generate a new line in the table, with the new consent process.

 

Most actions can also be performed from the site overview, by clicking on the Consent Event.

View/Sign consent document 

When viewing a specific consent document, it is possible to see the consent process with timestamps, the entire consent document with signatures (if available). Additional actions are available from within the view depending on the status of the consent, and ones collaborator permissions.

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The view will at a glance give an overview of when consent was started, and who has signed it and when. Along with which version of the consent was signed - and which consent is the latest version, incase the consent document has been updated.

It is from here collaborators with the verification permissions have the option of verifying the consent document.

Resend: There is the option of resending the email/sms containing the link to the consent document, in case the subject has not yet signed the document.

Investigator Countersign

If the collaborator has the "Sign Consent" permission for the site where the subject is enrolled, and the subject has signed the consent document, it will be possible for the collaborator to review the document and countersign it.

After accepting the "read and understood" condition, the investigator will write/draw their signature and press "Sign" a One-Time-Password will be sent via SMS. The password must be input to confirm the signature.Accept

 

Signature

OTP

Once the password has been confirmed, a success screen will be shown, and the view can be refreshed to see the document with signatures from both the subject and the investigator.

 

Re-Consent: How To

If re-consent is enabled for the process (can be done in amendment mode), and a new consent document has been uploaded in amendment mode - upon finishing the amendment, the study now uses a new consent document version.

Existing subjects, regardless of their current consent status, have an option to be re-consented using the new consent document.

From the eConsent overview table, it will be denoted with the action icon for subjects with a non completed consent status:

reconsent

Subject with a completed consent status must have their re-consent initiated when viewing the consent for a specific subject. Here the 'Signed version' and the 'Latest version' are both shown, ensuring clarity of which version of the consent the subject has signed, and which they can re re-consented to.

Clicking the re-consent button in either place will create another entry in the consent table for the subject, with the "Version" being different e.g. "1.0" vs "2.0".

Stopping a consent process/prevent access

Access to a consent document and thereby the to sign it for a subject, can be stopped/prevented by either:

  • Excluding the subject
  • Discontinuing the subject
  • Locking the Consent event.


Subject perspective 

This section details how the consent process looks from a subjects point of view.

The subject either receives an email/SMS with text specified during consent setup, or they can scan a QR code/paste a link if the consent is using "on-site" fill out.

Next the subject is met with an authentication screen, which requires them to input a one-time-password they have received via SMS:

Upon entering a valid OTP, they are taken to the consent document. Here they are asked to thoroughly read the document and proceed to signing it when they are ready.

To proceed they must click a checkbox and press continue.

On the signature page, the signature field will be automatically filled with their first name and last name, in a computer font. They have the option of changing the font, or pressing "Draw Signature" which will allow them to draw their own signature works very well with tablets/smartphones.

They also have the option of going back to the document incase they want to re-read the document.

Once happy with their signature, they press on "Sign Document" which will take them to an authentication screen, where an OTP must be entered. Which is only sent via SMS. Therefore it is very important the subject has a working phone number that can receive a SMS.

Once confirmed, they are presented with a success screen.

If the subject is enrolled in SMART-TRIAL with their email, they will receive an email once the investigator has countersigned the document, where they can download a signed copy of their consent document. If they wish to receive the consent document prior to the countersignature, they can request it from study personnel. Study personnel can then download it, and share it.