Patients & Participants

Learn how to create patients, add them to studies as participants, and track their status from candidate to completed.


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Managing Patient Information

In SiteVault, a patient is a person receiving care or treatment from a site, who may or may not be participating in one or more clinical studies at the site.

Creating Patient Records

Creating patient records enables you to associate patients with participant records and add them to one or more studies. When you create a patient record, you can choose whether the record should apply to all sites in your research organization or only to one specific site.

Complete the following steps to create a patient record:

  1. From the Profiles > Patients tab, select Create. You can also select Patient from the Create list.
  2. Enter required and any additional information as needed. If you want to allow the record to be used by all sites in your research organization, select the All [Research Organization Name] Sites option; if you want to limit the record to only the currently selected site, select the Only my current Site [Site Name] option.

Note If you're creating a patient record to consent a participant electronically using Veeva eConsent, ensure that you include a complete email address (for example, patient@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.

  1. Select Save to save the patient record, or select Save + Create to save and add another patient record.

If you need to edit a patient record, select Edit from the patient record’s Actions menu while in the Patients tab or open the patient record and select Edit.

Associating a Patient With an Existing Study Participant

Complete the following steps to associate a patient record with an existing study participant:

  1. Access the study and locate the participant that you want to edit in the Participants (Subjects) section.
  2. Select Edit from the participant’s Actions menu. You can also open the participant record (by selecting it) and select Edit in the upper-right corner.
  3. Search for and select the patient in the Patient field.
  4. Select Save.

Managing Participant Information

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:

  1. Open the study (by selecting the study link) in the Studies tab.
  2. Expand the Participants (Subjects) section and select Create.
  3. In the Create Participant dialog, enter the participant’s study-specific ID in the Study Participant ID field.
  4. If you want to associate an existing patient record with the participant, search for and select the patient in the Patient field.
  5. If you want to create a new patient record to associate with the participant, complete the following steps:
    1. Select into the Patient field, and select Create Patient from the list. Alternatively, select the More Search Options button (the binoculars button) and select Create in the dialog.
    2. Enter required and any additional information as needed, then select Save.
  6. Select Save to close the page and return to the study, or select Save + Create to add another study participant.

Managing Participant Status

A participant’s lifecycle enables you to manage and track the 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 participant’s action menu in one of the locations below. Ensure that you enter required and other information in the change state dialog as needed.

  • In the participant record detail page
  • In the Study Participation section of the patient record linked to the participant
  • In the Participants (Subjects) section of the study record to which the participant is assigned

Consenting a Participant Electronically

See the Veeva eConsent page for more information on consenting participants into a study using Veeva eConsent and SiteVault.

Deleting a Participant Record

Note The steps in this section can only be completed by a Regulatory user and only if the participant is not linked to other data records such as source documents.

To delete a participant record, select Delete from the participant record’s Actions menu in one of the following locations:

  • In the participant record detail page
  • In the Study Participant section of the patient record linked to the participant
  • In the Participants (Subjects) section of the study record to which the participant is assigned

User Types in SiteVault
Study eBinder

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