Learn how to create and manage Patient profiles.
Viewing Patient Profiles
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.
You can view the Patient profiles to which you have access in the Administration > Patients tab. With a site selected in the vault selector, SiteVault displays the Patient profiles that are specific to that site as well as any profiles that are shared across your research organization. For Research Organization Administrator users or users with the research organization-level Patients & Recruiting add-on, you can select your research organization in the vault selector to view all site-specific and organization-wide Patient profiles across your research organization.
Creating Patient Profiles
Creating Patient profiles enables you to associate patients with Study Participant records and add them to one or more studies. With the research organization selected in the vault selector, the Patient profile is created and shared across all sites in your research organization by default. With a site selected, you can choose whether to allow the profile to be visible for all sites or only the currently selected site. You can edit a Patient profile to update it from site-specific to research organization-wide but a research organization-wide profile cannot be made site-specific.
Complete the following steps to create a Patient profile:
- From the Administration > Patients tab, select Create.
- Enter required and any additional information as needed.
- If your site is selected in the site selector, select whether to make the profile available only to the currently selected site or to all sites in the research organization.
- Select Save.
Note If you’re creating a Patient profile 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. If you don’t enter contact information, you can still send the eConsent forms for signature, but the patient must complete the form in person. See the Consenting Participants page for more information on consenting participants electronically or in person at the site.
Creating Guardians and Proxies
Creating a record for a patient guardian or proxy enables you to send eConsent forms for electronic signature in conjunction with or on behalf of a study participant. See the Consenting Participants page for more information on consenting participants. You can also share documents with guardians and proxies. See the Sharing Documents With Study Participants help topic for more information.
Complete the following steps to create a guardian or proxy for a patient:
- Navigate to and open the profile for the patient.
- Expand the Guardians and Proxies 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 patient, search for and select the signatory in the Signatory field of the Create Patient Signatory 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 Guardian or Proxy as appropriate.
- Select Save.
Note If you’re creating a guardian or proxy to send an eConsent form to for signature in conjunction with or on behalf of a study participant, ensure that you include a complete email address (for example, guardian@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 electronically or in person at the site.
Editing or Deleting Patient Profiles
Research Organization Administrator users and Research Organization Staff users with the Patients & Recruiting add-on can edit or delete both site-specific and research organization-wide Patient profiles. Site Administrator users and Site Staff users with the Add Studies Patients & Recruiting add-on can edit or delete site-specific Patient profiles only for the site that’s currently selected in the vault selector. See the About System Roles and Add-on Permissions page for more information.
To edit a Patient profile, navigate to and open the profile and select Edit. To delete a profile, select Delete from the All Actions menu. Note that Patient profiles that are associated with a Participant record cannot be deleted.
Adding Patients to Studies as Study Participants
See the Managing Study Participants page for more information on associating Patient profiles with a Participant record on a study.