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 Site Connect 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.
- 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.
- Optional: If Veeva Site Connect is enabled in your Vault, configure for eConsent form exchange. See details below.
- Add the Connected Study Type 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.
Configure the Preview eConsent user action on the appropriate document lifecycle states so that users can preview eConsent forms in your Vault.
Send Documents to Sites
Configure the Send Document Via Clinical Network user action on the appropriate document lifecycle states so that eConsent users can perform the Send to Sites action on eConsent connected study documents.
Configuring for eConsent Form Exchange (Veeva Site Connect)
If Veeva Site Connect 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 the Clinical Network user actions.
In addition, you must populate the Connected Study Type field before users can send a Connected Study Invitation.