eConsent Process

Learn about the eConsent process and tools

eConsent Prerequisites

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.

Prerequisites

The following prerequisites must be met before you can send an eConsent form to a participant:

Prerequisite Description
Documents

Blank ICFs must meet the following prerequisites in order to be sent:

  • Workflow History: The blank ICF must have at least one Approved for Use version.
  • Study: The blank ICF must be for the study. You enter the study in the document’s Study field.
  • Veeva eConsent: The blank ICF must be an eConsent document as indicated by the Veeva eConsent field. The system automatically sets the Veeva eConsent field to Yes when you create a blank ICF, and the field is used to distinguish eConsent ICFs from paper ICFs.
  • Language: The blank ICF’s Language field must accurately reflect the document content language.

Additionally, you can’t send a blank ICF that has already been sent and is still with the participant. These in-progress ICFs are displayed in the eConsent Form dialog (denoted with an orange In Workflow icon), but you cannot select them.

Participants and Signatories

The following prerequisites must be met in order to send a blank ICF as an eConsent to a participant or signatory:

  • Language: The participant's selected language will limit the available consent forms. If an appropriate eConsent is not available, confirm the accuracy of the document and participant languages and adjust if possible.
  • Patient: A patient record must exist. The contact information in the patient record determines how they can sign eConsent forms:
  • If Then
    The patient record contains a valid email address and phone number capable of receiving SMS messages when you send them an eConsent form The participant is required to create a MyVeeva for Patients account or log in to their existing MyVeeva for Patients account to sign the eConsent form. This applies to remote signing and in-person signing.
    The patient record doesn't contain a valid email address and/or phone number capable of receiving SMS messages when you send them an eConsent form The patient is required to sign the eConsent form in person at the site and hand-draw their signature in MyVeeva for Patients. See Sending eConsent Forms to Participants to Sign In Person below for more information.
  • Participant: A participant record must exist for the patient and study and must be linked to the patient record.
  • Additional Signatories: If applicable, create records for any additional signatories such as a guardian, witness, or caregiver. The contact information in the signatory's record determines how they can sign eConsent forms:
  • If Then
    The signatory's record contains a valid email address and phone number capable of receiving SMS messages when you send them an eConsent form The signatory is required to create a MyVeeva for Patients account or log in to their existing MyVeeva for Patients account to sign the eConsent form. This applies to remote signing and in-person signing.
    The signatory's record doesn't contain a valid email address and/or phone number capable of receiving SMS messages when you send them an eConsent form The signatory is required to sign the eConsent form in person at the site and hand-draw their signature in MyVeeva for Patients. See Sending eConsent Forms to Participants to Sign In Person for more information.

Note MyVeeva for Patients users can update their email address and phone number in the MyVeeva for Patients Android, iOS, or web applications after they register their account. The information is automatically updated in SiteVault and your Site Administrator users are notified of the change.