Building an eConsent form works much like building an eCRF, but the reader is different and so the design rules are different. A participant sees one element at a time, then reviews a PDF at the end. Design for somebody reading on a phone who has never seen your study before.
Create a form
🛠️ Step by step guide
Navigate to eConsent Forms.
Select + new eConsent.
Provide the form's Name (used internally by the site), Language, Version, Version date and Center or centers.
Choose whether to build from scratch or from a template.
💡 Tip: three things about eConsent design that catch people out.
Section and subsection titles are invisible to the participant while they complete the form. They only appear in the final PDF. Do not rely on a title to explain what follows.
Use the Static Content question type for information and instructions, split into a block per chapter, rather than one wall of text. You can mix in real questions for the participant to answer.
The centers you attach matter: only users assigned to the study and to the same center as the form can select it when creating a record.
Edit a form
🛠️ Step by step guide
Navigate to eConsent Forms.
Select the edit icon on the form you want to change.
Configure your sections, subsections, questions and conditions.
The form saves itself as a Draft while you work, so you can change and test it freely. It can only be published once your study is Live.
Test your form
Test after every modification, not once at the end. The participant sees one element at a time, so problems with order and wording only become obvious when you read it the way they will. This works on any form still in Draft status.
🛠️ Step by step guide
Keep your eConsent form builder open.
Open the study in a second browser tab.
Navigate to Subjects and generate a test subject.
For that subject, open the eConsent tab.
Select + Add eConsent.
Choose No invitation.
If more than one form exists for that subject's center, select the one to use.
Select Invite.
On the generated record, open the options menu, the three dots, and select In-person Signing.
Check the confirmation box.
Scan the QR code, or use the open-in-new-tab icon to open the form in an incognito tab.
Work through the form as a participant would.
💡 Tip: while the test record is still incomplete, you can edit in the builder on one tab and reload the other to see the change immediately. Build and check in small steps rather than reviewing everything at the end.
If your tenant is not configured for In-person Signing, test by sending the form to yourself by email or SMS instead.
Publish your form
🔑 Prerequisite: your study must be in Live status. An eConsent form cannot be published from a Draft study.
Publishing is what allows you to start collecting real consent and signatures.
🛠️ Step by step guide
Navigate to eConsent Forms.
On the form you want, open the options menu, the three dots, and select Settings.
Change the status to Published and click Save.
⚠️ Warning: publishing deletes every existing test record for that form, automatically, to keep test data and real participant data apart. Anything you wanted to keep from testing has to be saved or screenshotted before you publish.
Two habits worth adopting before you press publish.
💡 Tip: document your validation of the form before publishing, so you can show later what was checked and by whom. And do not publish a form that has not been fully reviewed: changing one after go-live is slow and can affect data you have already collected.