The following terms are common in Veeva eConsent:
A blank ICF, which has a document type of Informed Consent Form (Blank), is the ICF that you edit to include your ICF content, review with your IRB, and approve for use in your study.
A blank ICF is like a template ICF for a specific study. Signed ICFs for participants are created using the most recently approved version of the blank ICF.
The placeholder ICF is saved to a participant’s documents as an Informed Consent Form (Signed) document when you send a blank ICF to a participant. It’s upversioned in SiteVault to include the patient signature or blank signature lines when the participant signs or declines the form in MyVeeva for Patients.
The signed ICF, which has a document type of Informed Consent Form (Signed), is the ICF with the patient’s signature that the site staff countersigns. It can be traced to the blank ICF version that the patient signed and vice versa. ICFs that are declined by the participant are also retained as a document with the document type of Informed Consent Form (Blank) but the signature lines are blank.
When you send a new version of a blank ICF on which a signed ICF is based to a participant, the participant’s signed ICF is upversioned and goes through the completion process in MyVeeva for Patients and SiteVault again.
An eConsent form is an electronic ICF that can be edited in the Veeva eConsent editor and signed by the participant in MyVeeva for Patients. The Veeva eConsent field is automatically set to Yes on eConsent forms, which distinguishes them from paper ICFs. eConsent forms include both a .PDF rendition and a Veeva eForm, which is a JSON file that contains the information for the electronic form.
|MyVeeva for Patients||
MyVeeva for Patients is the application in which participants and their signatories review and complete eConsent forms. See MyVeeva for Patients Help and the MyVeeva for Patients Resources page for more information.
|Veeva eConsent Editor||
The Veeva eConsent editor is opened when you select Edit eConsent from the All Actions menu on a blank ICF. It allows you to add, edit, and delete content from the ICF.