General eConsent Workflow

The process of creating eConsent forms and consenting participants into a study using Veeva eConsent uses the following general steps:

#	Step	Role	Actions	Help
If your study is connected to a sponsor's study in Clinical Operations, follow Steps 1 and 1a. If your study isn't connected to a sponsor's study, follow Step 1 and continue to Step 2.
1	Create Form	Sponsor or Site Staff	Create the ICF in Vault. Edit and customize the ICF in the Veeva eConsent editor. You can customize the form to include questions and answers, add media, or adjust the signature requirements. Approve the ICF in Vault.	eConsent Authoring in Clinical Operations Help Creating, Editing, and Approving eConsent Forms Using the Veeva eConsent Editor in Clinical Operations Help
1a	Share Form (Optional)	Sponsor and Site Staff (If using a form connected to a sponsor)	Share the form with the site using Connected Studies. Site staff can then make site-specific edits to the ICF using the Veeva eConsent editor, if necessary.	Connected Studies Using the Veeva eConsent Editor in Clinical Operations Help
2	IEC/IRB Review	Site Staff	Copy and share the ICF’s preview link to facilitate IEC/IRB review.	Previewing and Sharing an eConsent Form
3	Start Consent	Site Staff	Start the consent process by selecting Start Consent. The participant and additional signatories can either register a MyVeeva for Patients account to consent remotely or consent in person at your site.	Consenting Participants
4	Sign Form	Participants and Signatories	Participants and signatories review, sign, and submit the ICF in MyVeeva for Patients, either remotely or in person at your site.	Consent Forms in MyVeeva for Patients Help Consenting Participants
5	Countersign Form	Site Staff	Site staff countersign the completed ICF in SiteVault.	Countersigning eConsent Forms
6	Review Responses	Site and Sponsor Staff	Review the response data from the ICF if it includes questions. If the ICF is created by and connected to a sponsor, deidentified response data is also sent to the sponsor’s Clinical Operations Vault.	Viewing and Reporting on eConsent Form Responses

Additional Workflows

You can also learn more about the following workflows related to eConsent forms:

• Processing Declined eConsent Forms
• Canceling eConsent Forms
• Translating eConsent Forms