Create, update and publish an eConsent Form

Create and update an eCONSENT form

Creating an eCONSENT form follows a process similar to creating an eCRF.

However, the goal is different, as the eCONSENT form will be sent directly to participants, who will view one question at a time and at the end review a PDF document. Therefore, it is crucial to design an eCONSENT that is both intuitive and user-friendly for them to review, complete and sign.

🛠️ Step-by-step guides:

How to create a new eConsent Form

Navigate to “eCONSENT Forms”
Select “+ new eCONSENT”
Provide an eCONSENT :
- Name (used internally by the site)
- Language
- Version
- Version date
- Center(s)
Choose to build the form from scratch or from a template.

Note: Only users assigned to the study and the same center as the eCONSENT form can select and use it when creating a new record.

How to edit an eConsent

Navigate to “eCONSENT Forms”
Either Create a new eCONSENT form, or select the edit icon on an existing form
Configure your sections, subsections, questions, and conditions.

Your eCONSENT form will automatically be saved as a Draft, allowing you to make necessary changes and test the form. Once finalized, you can publish the eCONSENT, after setting LIVE your study.

Only users assigned to the study and linked to the same center as the eCONSENT form will be able to select and use it when creating a new record.

Use the Static Content question type to share information or instructions. Split your content into multiple static blocks for each chapter or section. You can also include questions for the participant to complete.
Section and subsection titles are not visible to the participant during completion, they will only appear in the final PDF. Keep this in mind when designing your forms.

Test your eConsent form

Testing your eCONSENT form is essential to ensure it is designed as intended. Subjects will view one element at a time.

It’s important to test the form after each modification to achieve an efficient and user-friendly design. The steps below apply to both creating a new form and editing an existing one, as long as the form is in Draft status.

🛠️ Step-by-step guide:

How to test an eConsent

Keep your eCONSENT form builder open
Open another Datacapt browser study page
Navigate to “Subjects”
Generate a new test subject
For this test subject, open the tab “eConsent”
Select "+ Add eConsent"
Choose "No invitation"
If more than one form exist for the Center attached to this subject, Select the form to use
Select Invite
Under the generated record, open the options menu (3 dots), select “In-person Signing”
Check "I confirm (...)",
Scan the QR code or Open the form in an incognito tab using the icon
Test your eCONSENT Form

💡Tips:

While the test eCONSENT record remains incomplete, you can apply an agile approach by making live modifications in the eCONSENT Form Builder on one browser tab and instantly verifying the results in the other. This ensures an efficient and iterative design process.
In case your client tenant is not configured to use In Person Signature, the solution is to send the eCONSENT using an eMAIL or SMS

Publish your eConsent form

Once you have tested and validated your eCONSENT Form, you can change its status to "Published" to begin collecting patient consent and signatures.

Important: Your study must be in LIVE status, not DRAFT, to publish eCONSENT forms.

🛠️ Step-by-step guide:

How to publish your eConsent form

Navigate to “eCONSENT Forms”
For the desired eCONSENT form, open the options menu (3 dots), select “Settings”
Update the eCONSENT Status to “Published”, click Save.

Important: ⚠️ When you publish an eConsent form, all existing test records are automatically deleted to ensure a clear separation between test data and real participant data.

💡Tips:

Document the validation of your eConsent form before publishing.
Avoid publishing a form that hasn’t been fully reviewed and validated,
making changes after go-live is time-consuming and may risk impacting collected data.

👉🏻 Next:

Learn how to generate and share eConsent to the participants
Learn how you can require the eConsent signature before enrollment

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