Using MyVeeva Studio

MyVeeva Studio allows you to create and manage surveys for your studies by creating collections. Collections include all languages and translations, all surveys, and all schedules and notifications required for your study. By default, you can access a study’s MyVeeva Studio from your Clinical Operations Vault if you have read access to the study and if you have access to the Launch MyVeeva Studio action.

The process of a sponsor creating a collection in MyVeeva Studio, a site administrator connecting it to their site in SiteVault, and site staff enabling participants and their caregivers in the study with ePRO uses the following general steps:

User Role Steps to Complete Additional Resources
Sponsor Staff Create and edit a collection for a study by creating surveys or importing surveys from a library
Sponsor Staff Add languages and survey translations necessary for the study Managing Survey Languages and Translations
Sponsor Staff Add study events to reflect the schedule of events in the study protocol Managing Events
Sponsor Staff Add schedules and notifications for surveys using the study events you created Configuring Schedules and Notifications
Sponsor Staff Download a .PDF overview of a collection to aid a study's IRB/EC submissions Exporting PDF Overviews of a Collection
Sponsor Staff Perform user acceptance testing (UAT) on a collection and approve it for use
Sponsor Staff Connect with sites on SiteVault to share approved collections
Site Staff
  • Site staff can select their study's patient supported languages as soon as their study is connected.
  • If local IRB/EC approvals apply, complete that process and mark the collection document as approved in SiteVault.
  • If no additional approvals apply, site staff can approve the collection document as soon as they receive the document.
  • Approval is not required for studies using only eClinRO surveys.
Site Staff
  • Enable study participants and/or caregivers with ePRO
  • Enter study event dates and times in SiteVault to begin survey schedules
 Enabling and Disabling ePRO for a Participant in SiteVault Help
Participants, Caregivers, and Site Staff
  • Participants and/or caregivers complete and submit their assigned surveys through MyVeeva for Patients.
  • Site staff complete and submit assigned surveys through SiteVault.
Sponsor Staff and Site Staff Export survey responses, adherence, and system audit trail data as participants, caregivers, and site staff submit surveys and Vault users interact with collections.
Sponsor Staff and Site Staff
  • If necessary, sponsor staff can upversion a collection for a study in the event of changes such as protocol amendments or the addition of languages.
  • Once sponsor staff perform UAT on and approve a new version of a collection, site staff also need to approve the new version in SiteVault to begin using it if:
    • The upversion affects languages their site supports
    • The upversion makes global changes to the collection such as adding new surveys, notifications, or events

Best Practices for Survey Configuration

To simplify the survey configuration process and ensure that participants and/or caregivers have a good user experience in MyVeeva for Patients, we recommend that you consider the following items while creating surveys for your study:

Topic Description
Faster Configuration

The following functionalities are available for quick ePRO configuration:

  • Import from the Veeva Library: The Veeva Library contains a variety of pre-configured and translated surveys, eliminating the need to re-translate a survey across studies. Using a survey from the Library can save you time and resources.
  • Import from Your Customer Library: You can save surveys you create in MyVeeva Studio to your customer library so that you can easily reuse them across studies. A survey's first version of translations is also saved to your customer library, eliminating the need to retranslate across studies.
  • Sample JSON Survey, Schedule, and Notification Templates: Veeva provides sample survey, schedule, and notification JSON templates to help you configure surveys in the JSON editor. You can download them from Sample JSON Survey, Schedule, and Notification Templates.
  • Copy-and-Paste: You can copy and paste text into the JSON editor while creating a survey.
  • JSON Editor Message Cues: MyVeeva Studio's JSON editor uses line-by-line error messages to assist you while you edit a survey's JSON.
Previewing Surveys We recommend that you preview your surveys during the creation phase. You can preview in-progress surveys by selecting the Preview Survey icon (Preview Survey icon) located above the JSON editor. See the Previewing a Survey section for more information.
Standard End Events The standard events of Study Complete and Study Withdrawn are always included in the MyVeeva Studio. We recommend that you include these as end events for all schedules, to ensure that if a participant is Study Complete or Study Withdrawn, they no longer have surveys or receive notifications for the study.