Note Veeva eConsent may be provided by your sponsor for use on a Connected Study or enabled for your SiteVault account as a paid add-on to use across all studies. Contact the Site Success Team to learn more.
Viewing eConsent Forms
When your study is connected to a sponsor, the sponsor can send connected eConsent forms to your site in Study Connect.
To view all eConsent forms sent to your site by the sponsor, complete the following steps:
- In Study Connect, select eConsent on the left menu.
- Select the Consent Forms tab.
- On the Blank Forms page, all eConsent forms sent to your site are displayed.
If you don’t need to preview or make any site-specific edits to the form, you can send it to participants for electronic signature right away by following the workflows on the Consenting Participants page.
If you need to create a preview of the form for your local IRB/EC reviews, follow the Previewing and Sharing an eConsent Form workflow below.
If you need to make site-specific edits to the form before sending them to participants, follow the Editing an eConsent Form, Sending an eConsent Form to the Sponsor/CRO, and Approving an eConsent Form for Use workflows below.
Editing an eConsent Form
Complete the following steps to access the Veeva eConsent editor and make site-specific edits to an eConsent form:
- In Study Connect, select eConsent on the left menu.
- Select the Consent Forms tab.
- On the Blank Forms page, locate the blank form you want to edit and select the Edit eConsent Form icon (
). The blank ICF is checked out, and the Veeva eConsent editor is opened in a new browser tab. - Make site-specific edits to the ICF as necessary. See Using the Veeva eConsent Editor in Clinical Operations Help to learn more about how to use the Veeva eConsent editor.
- When you’re ready to save to Vault or check in the document, select Save to Vault or Check In above the table of contents in the editor. Your progress is also saved automatically in the editor every 30 seconds.
Previewing and Sharing an eConsent Form
You can preview a blank ICF if you want to view the participant experience of the eConsent form. You can also share a link to the preview with third parties such as an IEC/IRB. External users can view the preview without a SiteVault or MyVeeva for Patients account. The preview link expires after 30 days, and if you delete the blank ICF, you or external users can no longer view the preview link.
The preview opened from SiteVault is version-specific. For example, you can share a preview of a draft version of an eConsent form or you can share a version that’s approved for use.
Complete the following steps to preview and share an eConsent form:
- In Study Connect, select eConsent on the left menu.
- Select the Consent Forms tab.
- On the Blank Forms page, locate the eConsent form you want to preview and select the Open Preview Link icon (
).
Note You can’t open the preview from Study Connect for an eConsent form that is currently checked out. Check in the document to access and share the preview.
- If you want to share the preview, copy the web address of the preview and share it as needed. The name of the user who created the preview, the date it was created, and the date it expires all are displayed on the Preview Mode banner. A mock Participant Preview user is displayed on the menu and used for the signature.
- If you want to preview the eConsent form, click through it as a participant would in MyVeeva for Patients. Items are marked complete on the table of contents as you view or otherwise complete them. You or an external user can interact with the preview to see how participants sign, submit, decline, and download the .PDF files, but the information is not saved to MyVeeva for Patients or SiteVault.
Note You can also download and import eConsent forms as Microsoft Word (.DOCX) files in the Veeva eConsent editor. See the Downloading eConsent Forms and Importing Microsoft Word Documents sections in Clinical Operations Help to learn more.
While you’re editing an eConsent in the Veeva eConsent editor, you may notice the Web Preview button in the upper-right corner. The Web Preview button allows you to preview your edits while you work and before you’re ready to share them. This web preview can’t be shared.
Sending an eConsent Form to the Sponsor/CRO
You can send an eConsent form to the sponsor/CRO for their review if you make site-specific edits to the form.
To send an eConsent form and any site-specific edits to the sponsor/CRO, complete the following steps:
- In Study Connect, select eConsent on the left menu.
- Select the Consent Forms tab.
- On the Blank Forms page, locate the blank ICF with site-specific edits and select the Send Document to Sponsor/CRO icon (
). - Optional: In the Send to Sponsor/CRO pop-up, enter comments about the ICF for the sponsor/CRO.
- Select Send.
Approving an eConsent Form for Use
You can approve an eConsent form for use when you receive an eConsent form from a sponsor, you’ve checked in the blank ICF from the Veeva eConsent editor, and you’ve completed any necessary reviews.
To approve an ICF for use, complete the following steps:
- In Study Connect, select eConsent on the left menu.
- Select the Consent Forms tab.
- On the Blank Forms page, select the blank ICF that you want to approve. The document viewer opens in a new browser tab.
- From the document Workflow Actions menu (
), select Change State to Approved for Use. The Change Status to Approved for Use dialog is displayed. - Select a date in the Document Date field.
- Select Start.