Learn how to create and manage participant records for your study.
In SiteVault, a participant is a patient who is being screened for or participating in a study. All participants are patients, but not all patients are necessarily participants.
Creating Study Participants
Complete the following steps to create a study participant:
- Navigate to and open the study for which you want to create a participant.
- Expand the Participants (Subjects) section and select Create.
- Enter the participant’s study-specific ID in the Study Participant ID field.
- If you want to associate a patient with this participant, see the Associating a Patient Profile with a Study Participant section below.
- Select Save.
Associating a Patient Profile with a Study Participant
You can associate a new or existing patient profile with a new or existing study participant record. While creating or editing a study participant, complete one of the following steps depending on whether you want to associate an existing patient profile or create a new one:
- If you want to add an existing patient profile, search for and select the profile in the Patient field. Tip: Select More Search Options (the binoculars button) in the Patient field to open a dialog that enables you to search and filter the available profiles.
- If you want to create a new patient profile, select into the Patient field and select Create Patient. The Create Patient option is at the bottom of the list of patients.
Note Once a study participant is invited to use MyVeeva for Patients (such as when you send them an eConsent form, share a study document with them, or enable them with ePRO), you can’t associate the study participant with a different patient profile.
Managing a Study Participant’s Status
The participant lifecycle enables you to manage and track a participant’s status throughout the study. When you first create the participant record, the initial status is Candidate.
To change a participant’s status, select the appropriate state (such as Change State to Pre-Screening) from the Workflow Actions menu of the participant record.
The figure below illustrates an express version of the sequence of states that are available for participant records in SiteVault. Click View Full Lifecycle to view the full sequence of states that are available for participant records in SiteVault.
Consenting a Study Participant Electronically
See the Consenting Participants page for more information on electronically consenting participants into a study using Veeva eConsent, SiteVault, and MyVeeva for Patients.
Creating Witnesses and Translators
Creating a record for a witness or translator signatory enables you to capture these additional signatures on eConsent forms for a study participant. If you need to add a proxy or guardian signatory for a patient, see the Managing Patients page.
Complete the following steps to create a witness or translator for a participant:
- Navigate to and open the participant record.
- Expand the Witnesses and Translators section and select Create.
- Complete one of the following steps depending on whether you’re adding an existing signatory or creating a new one:
- If you’re adding an existing signatory for a participant, search for and select the signatory in the Signatory field of the dialog box.
- If you’re creating a new signatory, select into the Signatory field and select Create below the list of existing signatories. In the Create Signatory dialog box, complete the required and any optional fields and select Save.
- From the Role list in the Create Patient Signatory dialog box, select either Witness or Translator as appropriate.
- Select Save.
Note If you’re creating a witness or translator to send an eConsent form for signature, ensure that you include a complete email address (for example, witness@veeva.com) and a phone number that can receive SMS text messages. To enter a phone number, select the country from the list and enter the area code and phone number. SiteVault automatically formats the number for you. If you don’t enter contact information, you can still send the eConsent forms for signature, but the signatory must complete the form in person. See the Consenting Participants page for more information on consenting participants.
Sharing Documents With Study Participants
You can share documents with study participants and their signatories through MyVeeva for Patients. The document types below are currently available to be shared. The document must be in its steady state (Approved for Use). When shared, the document is available to all participants on the study through MyVeeva for Patients. The documents are also available to any proxies or guardians.
- Advertisement for Recruitment
- Diary (blank)
- Participant Information Sheet
- Participant Materials - Other
- Participant Questionnaire (blank)
- Study Participation Card
To share a document, navigate to and open the document that you want to share, and select Share With Participants from the all actions menu (…). The Shared With Participants field on the document is updated to Yes.
If you upversion a shared document to a new steady-state version (such as 2.0), the new version automatically replaces the old version for all current recipients in MyVeeva for Patients.
If you need to stop sharing a document, select Stop Sharing With Participants from the document’s all actions menu (…). The Shared With Participants field on the document is updated to No, and the document is no longer available on the Documents page for users in MyVeeva for Patients.
Note that if you change the state of a shared document to Superseded, the document is not automatically removed from MyVeeva for Patients. To retract the document, use the Stop Sharing With Participants action.
Creating Visits for Study Participants
Using your preferred digital calendar platform (such as Gmail, Outlook, or Teams), you can create in-person or virtual study visits for a study participant to view details about and join in the MyVeeva for Patients app. You can create an in-person visit with instructions in the body of the invitation, or you can create a virtual visit containing a virtual meeting join link. Visits you create are organized in a visit list view for a participant to view and join from the Visits page in the MyVeeva for Patients app. You must have invited a participant to use MyVeeva for Patients in order to schedule visits for them in SiteVault. Sending them an eConsent form, enabling them with ePRO, or sharing a study document with them in SiteVault invites them to use MyVeeva for Patients.
Creating a Visit
To create an in-person or virtual study visit for a participant, complete the following steps:
- On the study record page, expand the Participants (Subjects) section and select the participant. The participant record opens.
- Locate the MyVeeva Calendar Alias field.
- Copy the participant’s MyVeeva calendar alias to your clipboard.
- In your preferred digital calendar platform, create a calendar appointment and enter the participant’s MyVeeva calendar alias as an invitee.
- Enter the correct date, time, and description for the visit as these details appear on the participant’s visit list in MyVeeva for Patients exactly as you enter them. Rich text formatting such as bold, italics, and underlines are supported. Ordered or bulleted lists, tables, indents, and attachments aren’t supported.
- If a visit is a virtual visit (such as through Meet, Skype, Teams, or Zoom), enter the virtual meeting join details in the description. The participant can join the virtual meeting in the MyVeeva for Patients app at the appropriate time.
- You can invite multiple study participants to the same visit by entering all applicable MyVeeva calendar aliases as invitees.
- Send the appointment invitation. The appointment is added to the participant’s visit list in MyVeeva for Patients. We notify the participant when you create a visit and when the visit is approaching. We also notify you when the meeting is processed and added to the participant’s visit list in MyVeeva for Patients or when the invitation fails to process.
Note You can only create a visit using an email address that’s linked to a SiteVault user account.
Updating or Canceling a Visit
You can update an existing visit’s details (such as the date, time, and description) or cancel a visit in your digital calendar platform. The changes you make to the visit apply to the participant’s visit list in MyVeeva for Patients. Canceling a visit removes it from the participant’s visit list. We notify the participant when you update or cancel a visit. We also notify you when the update or cancellation is successful or when it fails to process.
Note You can’t update or cancel a visit from your digital calendar platform if its meeting time is in the past. If you need to update a past visit, delete it from your digital calendar platform and create a new visit.
Editing a Study Participant
You can edit a participant’s information (except for their study participant ID) on their participant record. To edit a participant’s information, complete the following steps:
- On the study record page, expand the Participants (Subjects) section and locate the participant.
- To the right of their participant ID, select the all actions menu (…) and select Edit. The participant record opens.
- Expand any applicable sections on the record and edit the participant’s information.
- Select Save. The participant is edited.
Editing a Study Participant ID
Editing a study participant ID uses a different workflow than editing a study participant’s other information. To edit a study participant ID, complete the following steps:
- On the study record page, expand the Participants (Subjects) section and locate the participant.
- To the right of their participant ID, select the all actions menu (…) and select Edit Participant ID. The Start dialog box opens.
- Enter an edited participant ID and a reason for the change.
- Select Start. The participant ID is edited.
Resetting a Study Participant’s MyVeeva for Patients Password
You can reset a participant’s MyVeeva for Patients password if they forget their password and no longer have access to the phone number we have on file. To reset a participant’s password, complete the following steps:
- On the study record page, expand the Participants (Subjects) section and select the participant. The participant record opens.
- Locate the Patient field and select the Patient ID. The patient profile opens.
- Select the all actions menu (…) and select Reset MyVeeva Password. The MyVeeva for Patients Email Sent confirmation opens in a new window.
- Have the participant check their email inbox for a password reset email. Ask them to follow the instructions in the email to reset their account password.
Note This action is only available through configuration for SiteVault Enterprise customers.
Common Issues While Resetting a Study Participant’s MyVeeva for Patients Password
You or the participant may experience the following issues while resetting their password:
| User Issue |
Solution |
| The participant doesn’t receive a password reset email. |
Have the participant check their spam folder. If they still don’t receive an email from us, select Reset MyVeeva Password on the patient profile again. |
| I receive an error saying that the participant is unregistered. |
- Have the participant check their email inbox and spam folder for an invitation email from MyVeeva.
- If they receive the email, have them follow the instructions in the email to register their account. They can
choose a password when they register.
- If they don’t receive the email, confirm their email address in their patient record. If their email address is
correct, cancel the eConsent form or disable their ePRO and then resend the eConsent form or reenable them with ePRO. We
send the participant another email.
|
| I receive an error saying that the participant hasn’t been invited to register a MyVeeva for Patients account. |
The participant was never sent an eConsent form or enabled with ePRO, so they never received a MyVeeva for Patients
invitation email. You can’t reset their password in this scenario. |
| I receive an error saying that MyVeeva for Patients is having an issue with its website or servers. |
A problem occurred when we tried to send a reset password email to the participant. Select Reset MyVeeva Password again, or contact support if the problem continues. |
Deleting a Study Participant
To delete a participant record, complete the following steps:
- On the study record page, expand the Participants (Subjects) section and locate the participant.
- To the right of their participant ID, select the all actions menu (…) and select Delete. The Delete Record dialog box opens.
- Select Continue. The participant is deleted.
Note that only Research Organization Administrator or Site Administrator users or users with the All Studies Patients & Recruiting add-on can delete a participant record. In addition, the record can’t be associated with any study documents.