During clinical trials, sponsors and CROs provide research sites with Informed Consent Form (ICF) templates, which can be modified by each site and used to consent new participants on the trial. Users can create, edit, and save eConsent forms in your Clinical Operations Vault.
In Clinical Operations Vaults with Veeva eConsent enabled, you can exchange eConsent forms with study sites on SiteVault. Study sites can then use the templates to create blank ICF documents and distribute the approved eConsent forms to study participants. Study participants sign these forms in MyVeeva for Patients.
Note: This feature is only available on Clinical Operations Vaults.
Configuration Overview
- Add the Veeva eConsent (
myveeva_econsent__v) shared field to the appropriate document types so that users can create and edit those document types in the Veeva eConsent editor. - Configure the Draft eConsent event action on the appropriate document lifecycle’s existing Create Draft event action so that Vault automatically copies the Veeva eForm (
veeva_eform__v) rendition type to the new document version after users check in the document from the Veeva eConsent editor. - Configure user actions on the appropriate document lifecycle states to enable users to check out documents to edit in the Veeva eConsent editor, cancel their check out and preview eConsent forms.
- Configure eConsent user action for sending eConsents to sites.
- Add the eConsent field to the Study object page layout.
Configuring User Actions
Edit eConsent & Cancel eConsent
Configure the Edit eConsent and Cancel eConsent user actions on the appropriate document lifecycle states. If relevant to your business processes, select the Perform with conditions option so that the user action only appears on documents that meet a set of conditions. For example, you can configure it to perform with the condition If Classification includes Informed Consent Forms so that the actions only appear on the appropriate document types.
Note: Do not configure the Edit eConsent and Cancel eConsent user actions on the Steady state of a document lifecycle.
Preview eConsent
Configure the Preview eConsent user action on the appropriate document lifecycle states so that users can preview eConsent forms in your Vault.
Configure eConsent Send to Sites
You can add the eConsent Send to Sites user action to any active document lifecycle state. When configured, this action allows users to select the eConsent Send to Sites option from a document’s Actions menu to send documents to SiteVault sites from their Library.
Select a State Change for the user action to specify which lifecycle state the document enters in the source Vault once Vault successfully transfers it to the site.
Note: If you use the State Change option, you are limited to just one eConsent Send to Sites user action per lifecycle. This user action only appears to users if an eConsent was created and checked in from the eConsent editor.
This user action only appears to users if there are active Agreements associated with the Study or Study Sites related to the document.
Configuring for eConsent Form Exchange
If Veeva eConsent is enabled in your Vault, users can exchange eConsent forms with SiteVault. To support the exchange of eConsent forms between your Vault and a SiteVault, map the appropriate document types to the Informed Consent Form artifact in your Vault. When configured, users can transfer eConsent forms to SiteVault via user actions.
In addition, you must populate the eConsent field before users can send an eConsent to sites.