Learn how to lock and unlock eConsent forms for participants to review using unlock codes.
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.
Locking and Unlocking an eConsent Form
An eConsent form may require an unlock code that allows participants and their signatories to review forms before in-person or virtual consenting visits while preventing them from signing. This enables sites to ensure that the participant or signatory discusses the form and study with site personnel before signing. When you create an unlock code and provide it to a participant or signatory, they can sign the unlocked form.
To create an unlock code, 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 ICF and select the Open Preview Link icon (). The preview is opened in a new tab of your browser.
- Ensure that you’re viewing the most recently approved (steady-state) version of the blank ICF. Unlock codes are valid for only specific versions, and participants review the currently approved version.
- After you review the form with the participant or signatory, go to the signature section of the form.
- Select the Create Unlock Code link under the signature block. The Create Unlock Code dialog box is displayed.
- If you want to change when the code will expire, select an option from the Code Will Expire In list. The default is 15 minutes. The code can be used for any signed ICF based on the blank ICF version, so ensure that you keep this in mind when setting the expiration timeframe and sharing the code.
- Select Create Code. The unlock code and the amount of time until it expires are displayed in the dialog box. If you close the dialog box, the code is displayed under the signature block.
- If the code expires and you want to create a new one, complete one of the following steps:
- If you still have the dialog box open, select Create New Code. A new code is displayed with the same expiration option as the previous one.
- If you’ve closed the dialog box or preview, repeat the steps above.
See the Requiring an Unlock Code to Sign section in Clinical Operations Help for more information about how to require an eConsent form to use an unlock code.
Note The Create Unlock Code link is displayed only if you came to the preview from SiteVault, only on previews for blank ICFs that are approved for use, and only for blank ICFs that are set to require unlock codes. External viewers can’t create codes.