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.
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 record for the study participant.
- 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.
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 detail page 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.
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.