Consenting Participants

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


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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

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

  • Patient: A patient record must exist and must include an email address and phone number.
  • Patient Email Address: The complete email address must be present, for example, patient@veeva.com.
  • Patient Phone Number: The phone number must be able to receive SMS text messages.
  • Participant: A participant must exist for the patient and study and must be linked to the patient record.

MyVeeva for Patients uses the email address and mobile phone number on the SiteVault patient record for account registrations, eConsent invitations, and multifactor authentication (MFA). If the information is incorrect, the patient cannot access and complete the ICF.

Note As of August 19, 2021, SiteVault checks whether patient phone numbers and email addresses are formatted correctly when you add or update them for a patient. For any phone numbers or email addresses that were incorrectly formatted before this date, you'll need to update the information before being able to send an eConsent form successfully. See the Troubleshooting MyVeeva for Patients section below for more information.

See the Patient and Participant page for more information on adding or updating patient contact information.

Sending eConsent Forms

When your blank ICF or ICFs for the study are in the Approved for Use state and the participant has a phone number and email address on their associated patient record, you can send the ICFs in SiteVault from the participant’s Actions menu on the list of participants or the participant record.

You don’t need to know whether the participant has a MyVeeva for Patients account in order to send them an eConsent form. If the participant doesn’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.

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

  1. Access the study in SiteVault.
  2. Expand the Participants (Subjects) section.
  3. Select the linked ID in the Study Participant ID column. The participant record is displayed.
  4. Select Send eConsent from the participant’s Actions menu. The eConsent Form dialog 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 Continue. A success message is displayed. 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 MyVeeva for Patients section below for more information about issues that participants may encounter.

Consenting a Participant In Person

Example QR code

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

Complete the following steps to generate an in-person consent code:

  1. Navigate to and open the record for the study participant.
  2. Select View In-Person Code from the Actions menu. The in-person QR code is displayed in MyVeeva for Patients in a new tab of your browser window.

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

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 in SiteVault when you sent the eConsent 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 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.

While the ICF is waiting on the patient signature, 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, Patient Signed, or Patient 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, and 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.

Patient Signed

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

Patient 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 and Troubleshooting MyVeeva for Patients sections 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 Actions menu on a blank ICF to see the signed ICFs that were created from it.

Countersigning eConsent Forms

After the participant signs and submits 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 signatory 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 participant has signed and submitted the eConsent form, we recommend completing the countersignature task as soon as possible.

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 completes an eConsent form that contains a signature, questions, and response options, SiteVault records the participant’s 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 participant’s 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 responses and associated questions or signatures 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

Regulatory 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 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 hasn’t signed yet. The patient 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 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 declines an eConsent form in MyVeeva for Patients, the Veeva eConsent Status field for the document in SiteVault is updated to Patient 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.

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 Patient and Participant page and the Cancelling an eConsent Form section for more information.

Troubleshooting MyVeeva for Patients

Registration and Logging In

The patient may experience the following issues while registering their account and logging in to MyVeeva for Patients:

Patient Issue Resolution
I didn’t receive the eConsent email that my site told me to expect.

If the patient doesn’t receive the email, the email may be incorrect in SiteVault or an error might have occurred. To resolve this issue, complete one of the steps below, depending on the status of the eConsent form. You can determine the status by checking the Veeva eConsent Status field on the signed ICF documents that were created for the participant.

  • Delivered: If the status is Delivered, verify that the email address on the participant’s patient record is correct. Complete one of the following actions depending on whether the email is correct:
    • Incorrect: If the email address is incorrect, correct the email address on the patient record, cancel the eConsent forms you sent, and resend the eConsent forms. See the following help topics for more information:
    • Correct: If the email is correct, have the patient check their spam folder and trash. If the patient has an alternate email address, you can also complete the steps in the Incorrect item above to resend the ICFs to a different email address.
  • Not Delivered: If the status is something other than Delivered, wait one hour and check again. If the status is still not Delivered after an hour, contact Veeva and we’ll check the logs for errors. We recommend waiting an hour because the SiteVault system adds the document to a queue to retry at the beginning of the next hour if the operation fails in SiteVault.

See the Tracking eConsent Forms section above for more information about the statuses.

I lost or deleted my eConsent email before completing my eConsent form.

Ask the patient to check their spam folder and trash. If the patient didn’t set their password and log in before they deleted the email, you can cancel and resend the eConsent form and they’ll receive a new email.

If the patient registered their account but didn’t sign or decline the forms, you can also ask them to log in directly at https://patients.myveeva.com/. Their uncompleted forms will be displayed when they log in.

I’m having trouble creating a password.

Ensure that the patient is meeting the password requirements displayed on the registration page and explain what special characters are if they aren’t sure. You can also ask them to check that their caps lock isn’t on.

See the Account page on the MyVeeva for Patients Help website for more information about how patients set passwords.

I tried to reset my password but didn’t receive an email.

Complete the following steps to resolve this issue:

  1. Ask the patient to check their spam folder and trash.
  2. If the patient can’t find the email, ensure that you have the correct email address on the patient record. If not, update the patient record and resend the eConsent form.
  3. If the patient still doesn’t receive the email, contact Veeva and we’ll check the logs for errors.
I received a password reset email, but I didn’t request it.

Although it's most likely that someone else accidentally entered the incorrect email address when attempting to reset their own password, ask the patient to reset their password to err on the side of caution and prevent losing access to their account.

See the Account page on the MyVeeva for Patients Help website for more information about how patients reset passwords.

I can’t log in. The application says the credentials don’t match any in MyVeeva for Patients.

Complete the following steps to resolve this issue:

  • Email Correct: Verify that the patient is using the same email address that the site staff entered on the patient record in SiteVault and for which they registered their account.
  • Password Correct: Verify that the patient doesn’t have their caps lock on, and help the patient reset their password if needed.
  • Web Address Correct: Verify that the patient is trying to log in at the correct regional address of MyVeeva for Patients. If they try to log into the EU region with an email address that is registered for only the US region, for example, they’ll see an error message. They can enter their email address at https://patients.myveeva.com/ and be redirected to the correct regional address for their account, or they can go to the regional address directly. Currently, the following regions are supported:
    • EU: patients-eu.myveeva.com
    • US: patients-us.myveeva.com

See the Account page on the MyVeeva for Patients Help website for more information about how patients log in and reset passwords.

I requested a verification code, but I didn’t receive a text message.

Complete the following steps to resolve this issue:

  1. Verify that the correct mobile phone number is entered on the patient record in SiteVault.
  2. If the phone number is not correct, update the patient record, cancel the eConsent forms, and resend the forms. See the following help topics for more information:
  3. Verify that the patient has a cellular signal, has SMS enabled, and doesn’t have their phone in airplane mode.
  4. Contact Veeva and we’ll check the logs for errors.

Reviewing and Signing eConsent Forms

The patient may experience the following issues while reviewing and signing eConsent forms in MyVeeva for Patients:

Patient Issue Resolution
I have questions about the informed consent content.

Ask the patient to speak with a member of the site staff who can explain the ICF’s content.

The text is too small to read.

Instruct the patient on how to zoom in using their browser. MyVeeva for Patients also supports screen readers and keyboard navigation.

I can’t sign the form. It says I haven’t read or completed all the sections.

Complete the following steps to resolve this issue:

  • Explain to the patient how to determine which sections are incomplete using the table of contents. If the user is on a mobile device or smaller screen, they need to select the Table of Contents button to view it.
  • Ask the patient to make sure they’ve viewed each section and answered any required questions. Completed sections have a green checkmark next to them on the table of contents. Additionally, when the participant attempts to click the signature field before completing all the sections, we flash the incomplete sections with an orange border on the table of contents.

See the eConsent page on the MyVeeva for Patients Help website for more information.

When I submit the document, the progress indicator spins and the message doesn’t close. Was my document submitted?

Complete the following steps to resolve this issue:

  • Explain to the patient that it may take a few moments to send the form from MyVeeva for Patients to the site’s system.
  • Ask the patient to refresh their browser, log out, and log back in. If the document was successfully submitted, they should be able to view the signed document.
  • Check whether the signed ICF was received in SiteVault.

See the eConsent and Documents pages on the MyVeeva for Patients Help website for more information.

I closed my browser before I signed and submitted the document. How do I continue?

Ask the patient to log back in at https://patients.myveeva.com/. MyVeeva for Patients tracks the patient’s progress through their uncompleted documents, so they can resume reviewing and signing documents easily.

See the eConsent page on the MyVeeva for Patients Help website for more information.

How do I download or print a consent form?

The patient can select the Download PDF button in the upper right corner on completed or uncompleted documents to download a form and can use their browser’s or device’s functionality to print it.

See the Documents page on the MyVeeva for Patients Help website for more information.

I received a new version of a consent form I already signed. What changed?

Compare the current steady state version of the blank ICF in SiteVault to the blank ICF version that the participant previously signed using Vault’s compare version functionality. You can determine the blank ICF version that the participant previously signed by viewing the Approved ICF Version section of the previously signed ICF's document information.

See the Comparing Documents section of the Managing Documents page for more information.

Other Patient Issues

The patient may also experience the following issues in MyVeeva for Patients or during the consent process:

Patient Issue Resolution
I declined an eConsent form accidentally or I changed my mind. How do I sign?

Participants should contact the study site to inform them.

Site staff can resend the same version or send a new version of the blank ICF to the participant. See the Processing Declined eConsent Forms section for more information.

I want to withdraw from the study. How do I do that?

Participants should contact the study site to request to withdraw.

The site should follow their existing standard operating procedure (SOP) for withdrawing a participant from a study in SiteVault. If a participant has outstanding uncompleted eConsent forms, the site should cancel those eConsent forms. You can’t cancel an eConsent form that has been completed in MyVeeva for Patients.

If a participant wants to delete their MyVeeva for Patients account, the site should contact Veeva. Otherwise, the participant can keep their account active to be able to view their existing documents and possibly use the account for other studies in the future. MyVeeva for Patients accounts can be used for multiple sites and studies.

I think someone has hacked my account. What do I do?

Ask the participant to contact Veeva’s security team at security@veeva.com.


Managing eConsent Forms
Veeva eConsent Glossary