Consenting Participants

Learn how to send approved eConsent forms to participants and their signatories to sign in MyVeeva for Patients and countersign them in SiteVault.


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:

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.

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:

  • Patient: A patient record must exist. If you want to consent the participant electronically, ensure that you include a complete email address and phone number capable of receiving SMS text messages. If you don’t enter contact information for the patient, you can still send the eConsent forms to them for signature, but the patient must complete the form in person.
  • 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 or witness. If you want to consent the signatories electronically, ensure that you include a complete email address and phone number capable of receiving SMS text messages. If you don’t enter contact information for the signatories, you can still send the eConsent forms to them for signature, but the signatories must complete the form in person.

See the Managing Patients and Managing Study Participants pages for information on creating or updating patient, signatory, and participant records.

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

Sending eConsent Forms

When your blank ICF or ICFs for the study are in the Approved for Use state and the participant and any applicable signatory records exist, you can send the ICFs in SiteVault from the All Actions menu on the participant’s record.

You don’t need to know whether the participant or signatory has a MyVeeva for Patients account in order to send them an eConsent form. If they don’t have an account for the email address entered in SiteVault, they’ll be prompted to register when they access MyVeeva for Patients from the invitation email or in-person consent code. If they already have an account for the email address, they can log in and access the documents for your study.

Additionally, you can send eConsent forms to participants and signatories without entering contact information in SiteVault or them registering for a MyVeeva for Patients account. In such cases, the system requires them to sign during an in-person consenting session and to draw their signature in place of dual-factor authentication. See the Consenting a Participant In Person section for more information.

If the prerequisites above are met, complete the following steps to send one or more ICFs to a participant and their signatories to review and complete:

  1. Access the study and expand the Participants (Subjects) section.
  2. Select the linked ID in the Study Participant ID column. The participant record is displayed.
  3. Select Send eConsent from the participant’s All Actions menu. The Send eConsent dialog box is displayed.

Tip You can also send eConsent forms by selecting Send eConsent from the actions menu next to the linked participant ID on the participant list, but we recommend checking the status of the participant’s documents on the participant record after you send eConsent forms to verify that they were delivered.

  1. Search for and select the ICF or ICFs that you want to send to the participant. The documents displayed are filtered per the prerequisites listed above for the documents.
  2. Select Next. The Signatory page of the dialog box is displayed.
  3. Review the list of signatories to ensure that the list of signatories and their contact information are correct. Select or deselect signatories as needed. If you’re sending more than one ICF, select Next to proceed to the next ICF, or select Previous if you need to return to a previous step.
  4. Select Send. If the patient has not signed a version of the blank ICF before, a placeholder document is added to the list of documents for the participant. If the patient has signed a previous version and this is a reconsent, a new minor version is added to the signed ICF.

See the Troubleshooting Veeva eConsent and MyVeeva for Patients page for more information about issues that participants may encounter.

Consenting a Participant In Person

Example QR code

You can create and scan an in-person consent code to have participants or other signatories complete eConsent forms in person using a site’s device. A participant or signatory can scan the QR code or go to the web address shown onscreen to access MyVeeva for Patients. This in-person consenting functionality bypasses the invitation email and makes it easier to have participants and signatories complete eConsent forms at the office or another location where they may not have their own device.

If a patient doesn’t have contact information in SiteVault or isn’t registered for a MyVeeva for Patients account, they must sign during an in-person consenting session and hand-draw their signature in place of dual-factor authentication.

Complete the following steps to have participants or signatories complete eConsent forms in person:

  1. Navigate to and open the record for the study participant. If not already sent, select Send eConsent from the All Actions menu to send the ICF to the participant and signatories. See the Sending eConsent Forms topic for more information.
  2. Select View In-Person Code from the All Actions menu. The in-person QR code is displayed in a new tab of your browser window.
  3. Scan the QR code with a tablet or mobile device. The MyVeeva for Patients web app is opened in the device’s browser, and the participant or signatory can review and complete the consent forms. See the Consent page in MyVeeva for Patients Help to learn more.

Note If signatories are associated with the participant and completing forms, you’ll select the users one at a time on the device. After you select a user, they can log in and complete the forms, and after they finish, you can select the next one.

When the participant completes all their documents, they’re logged out automatically after 30 seconds of inactivity or if the browser is closed.

Unlocking an eConsent Form

Create Unlock Code

Unlock codes allow participants and their signatories to review forms before in-person or virtual consenting visits while preventing them from signing before site personnel provide the code. This enables sites to ensure that the participant or signatory discusses the form and study with site personnel before signing.

If the form requires an unlock code for the participant to sign, you can create the code in the preview opened from SiteVault. Complete the following steps to unlock a document:

  1. Access the blank ICF for the consent form in SiteVault. Ensure that you’re viewing the most recently approved (steady-state) version of the blank ICF. Unlock codes are valid for only specific versions, and participants review the currently approved version.
  2. Select Open Preview Link from the All Actions menu. The preview is opened in a new tab of your browser.
  3. After you review the form with the participant or signatory, go to the signature section of the form.
  4. Select the Create Unlock Code link under the signature block. The Create Unlock Code dialog box is displayed.
  5. If you want to change when the code will expire, select an option from the Code Will Expire In list. The default is 15 minutes. The code can be used for any signed ICF based on the blank ICF version, so ensure that you keep this in mind when setting the expiration timeframe and sharing the code.
  6. Select Create Code. The unlock code and the amount of time until it expires are displayed in the dialog box. If you close the dialog box, the code is displayed under the signature block.
  7. If the code expires and you want to create a new one, complete one of the following steps:
    • If you still have the dialog box open, select Create New Code. A new code is displayed with the same expiration option as the previous one.
    • If you’ve closed the dialog box or preview, repeat the steps above.

See Requiring an Unlock Code to Sign in the Veeva eConsent editor help for more information about how to require an unlock code.

Note The Create Unlock Code link is displayed only if you came to the preview from SiteVault, only on previews for blank ICFs that are approved for use, and only for blank ICFs that are set to require unlock codes. External viewers can’t create codes.

Cancelling an eConsent Form

Cancelling an eConsent allows you to withdraw it and have it not displayed in or available to complete in MyVeeva for Patients. This can be useful if you send an incorrect eConsent form, send an eConsent form to the incorrect participant, or you had an incorrect phone number or email address for the patient or signatory in SiteVault when you sent the eConsent form. When you cancel an eConsent form, the form is canceled for all signatories, even if one or more of the signatories have already completed the form.

Complete the following steps to cancel an eConsent form:

  1. Access the signed ICF that you want to cancel. You can do this in the Library or from the list of documents on the participant record.
  2. Select Cancel eConsent from the document’s All Actions menu. One of the following actions occur, depending on the history of the eConsent form you canceled:
    • Placeholder ICF: If you cancel a placeholder ICF that was created when you sent an ICF and has not previously been signed by the participant, the placeholder ICF is deleted. If you later resend the same ICF, a new placeholder with a new document ID is created.
    • Signed or Approved ICF: If you cancel an ICF that is not a placeholder (for example, an ICF that you’ve resent after it was previously signed and approved by the patient and site staff), the minor version is deleted. If you later resend the ICF, a new minor version is created of the signed ICF and the version history omits the deleted version.

Tracking eConsent Forms

Tracking the Veeva eConsent Status

You can view the Veeva eConsent status of ICFs in the following locations:

  • Document: You can view the status of the ICFs in the Veeva eConsent Status field on signed ICFs and placeholders.
  • Participant: You can view the status of the ICFs sent to a participant in the Documents section of the participant record.
  • Additional Signatories: You can view the status of a participant’s or signatory’s signature in the Form Responses section of the participant record.

While the ICF is waiting on the participant and signatory signatures, the document status (the value in the Status field) is Draft. The Veeva eConsent Status field provides more detailed information regarding the status of the eConsent form that was sent to the participant. Signed (or sent) ICFs can be in the Veeva eConsent statuses below. Typically (if no error or delay in processing occurs), documents will be in a Delivered, Viewed eConsent, Signed, or Declined status. You may need to refresh the page several times before a document progresses from Initiating to Delivered.

Status Description
Delivered

The eConsent form was delivered to the participant. If contact information was provided, an invitation to view the eConsent forms for your study in MyVeeva for Patients should be in the participant’s email.

Viewed eConsent

The participant viewed the eConsent form in MyVeeva for Patients but has not yet completed the form.

Signed

The participant and any additional signatories signed and submitted the eConsent form in MyVeeva for Patients.

Declined

The participant declined the eConsent form in MyVeeva for Patients.

Initiating

The SiteVault system is sending the eConsent form to the MyVeeva for Patients system.

Processing

The SiteVault system successfully sent the eConsent form to the MyVeeva for Patients system, and the MyVeeva for Patients system is processing the delivery.

Error

The SiteVault system sent the eConsent form to the MyVeeva for Patients system, but the operation failed for an unrecoverable reason.

Delivery Failed

The MyVeeva for Patients system was unable to deliver the eConsent form to the patient. This is likely due to an incorrect email address. See the Prerequisites section and the <a href="/gr/econsent/econsent-troubleshooting/>Troubleshooting Veeva eConsent and MyVeeva for Patients</a> page for more information.

Viewing Failed

The patient was unable to view the eConsent form in MyVeeva for Patients.

Not Applicable

This document isn’t a Veeva eConsent form. This status is the default status and is used for signed ICFs that are not eConsent forms (paper ICFs).

Tracing Signed ICFs and Approved Versions

For traceability purposes, you can view which version of an approved blank ICF a signed ICF was created from in the Approved ICF Version section of the signed ICF’s document information.

You also can select Where Used from the All Actions menu on a blank ICF to see the signed ICFs that were created from it.

Countersigning eConsent Forms

After the participant and any additional signatories sign and submit the eConsent form in MyVeeva for Patients, the signed form is uploaded to SiteVault and routed for eSignature (countersignature) to the site user who sent the document. The user will receive an email notification when the eConsent form is ready for countersignature.

To complete the countersignature task and make the eConsent Current:

  1. Access the task list from Home > My Tasks and select the task.
  2. Select Complete in the task bar.
  3. Select the appropriate role and verdict.
  4. Enter your SiteVault credentials and select Complete.

Once the signatories have signed and submitted the eConsent form, we recommend completing the countersignature task as soon as possible. When the site user countersigns the form, the .PDF files in SiteVault and MyVeeva for Patients are updated to include the electronic countersignature on the last page.

Viewing eConsent Form Responses

For any questions, response options, and signatures that are included on your eConsent form, you can view and report on the responses collected from participants in MyVeeva for Patients during the eConsent process.

After a participant and any additional signatories complete an eConsent form that contains a signature or questions and response options, SiteVault records the signatures and answers in the participant’s study record. The responses are added in a Draft status and are updated to a Current status once the site user who sent the document countersigns the form. If you send an updated eConsent form with updated signature, questions, and response options, the previous responses are moved to a Superseded status and the newly collected responses are made Current.

Complete the following steps to view a study participant’s eConsent form responses:

  1. Access the study and expand the Participants (Subjects) section.
  2. Select the linked ID in the Study Participant ID column to open the participant record.
  3. Expand the Form Responses section. The participant’s and any signatories’ signatures and responses and associated questions are displayed on a table with additional information such as the status of the response and the associated blank and signed ICFs.

Reporting on eConsent Form Responses

Research Organization Administrator or Site Administrator users can create a report to report on eConsent form responses. For example, you can create a report to view responses across one or more participants for one or more questions or signatures, or you can create a report to view Approved for Use form signatures, questions, and answers along with any associated Superseded responses.

The signature, question, and response names are defined by what is entered in the editor on the blank ICF. They can be either the default names or customized names. You can use the labels to aggregate response data across separate documents and studies when you create reports. We recommend that you use unique labels in a data set for easy organization and reporting. See the Editing eConsent Forms page (on the MyVeeva for Patients website) for more information.

Reconsenting a Participant

If you want to reconsent a participant, complete the steps below. You can send either the same version or a new version of the blank ICF that the participant and signatories signed before. Additionally, you don’t need to send an updated version if you sent the previous Approved for Use version to the participant and the participant or their signatories haven’t signed yet. The MyVeeva user always sees the latest approved version in MyVeeva for Patients up until the point when they sign.

  1. Ensure that the new version of the blank ICF is in an Approved for Use state and that the prerequisites in the Prerequisites section are met. To update an existing approved ICF, you can select Create Draft from the All Actions menu, select Copy File From Current Version then edit, check in, and approve the ICF when it’s ready.
  2. Repeat the steps in the Sending eConsent Forms section and send the latest approved version of the ICF or ICFs.

Note When you send a new version of an ICF to a patient, the eConsent form is displayed on their list of documents as a new version. When they sign and submit the new version, it will be added to SiteVault and the approver will be assigned a task to countersign the new version.

Processing Declined eConsent Forms

When a participant or signatory declines an eConsent form, the Veeva eConsent Status field for the document in SiteVault is updated to Declined and a notification is sent to the approver. The notification enables the site staff to perform any actions required by their organization. For example, the site staff may need to update the candidate’s status or not collect certain biosamples at the next visit. When any signatory declines an eConsent form, it’s also declined for any signatory who hasn’t signed it.

The signed ICF is displayed on the participant’s list of documents and retained in the library to maintain your records. If you want to hide declined eConsent forms in your library, you need to set up views to do so. You can’t cancel a declined eConsent form.

If a participant declined the form in error or changed their mind, you can resend the form. When you resend a previously declined form, a new minor version is added to the signed ICF. See the Sending eConsent Forms section for more information.

Withdrawing a Participant

If a patient wants to withdraw from a study, they’ll need to contact the site staff and request it. You can then update the participant’s status in SiteVault.

See the Managing Study Participants page and the Cancelling an eConsent Form section for more information.


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