Overview

Studio allows you to manage the study build, which is referred to as a collection. Collections include the following information, which represent your study protocol, in all languages defined for the study:

  • Surveys: Both ePRO and eClinRO surveys are added here.
  • Groups: This determines who gets which surveys or events.
  • Languages and Translations: This allows you to track and maintain which languages are permitted and whether the required material is translated.
  • Schedules and Notifications: You can create schedules using standard events or events you add, and you can create notifications for each survey.
  • Study Details: You can provide a study description and image that appears to participants and/or caregivers in the MyVeeva for Patients app.

Collection versions are created in a draft state until they’re approved. Only approved collections are shared with sites and assigned to participants and/or caregivers once activated by the site.

The Study Settings tab includes tabs for Study Languages and Resources, which are items that affect an entire study and are not associated at the collection level.

You can access a study in Studio if you are assigned as a Study Builder on the study or have the appropriate administrative permissions.

  1. Complete the following steps to access Studio from your ePRO Vault:
  2. Open the study record.
  3. From the All Actions menu, select Open Studio.

Viewing and Managing Study Settings

The Study Settings for a study are the items that are related to the study but don’t need to be updated as part of collection versions. Select the Study Settings tab to access the following sub-tabs.

  • Languages: The languages that can be added for the study and available for resources and to add to collections. See Adding Study Languages for more information.
  • Resources: Resource links can be added to allow sponsors to add resources that participants can use. See Managing Resource Links for more information.

Workflow Overview

Building an ePRO study and making it available to sites, participants, and caregivers follows the workflow below.

User Role Steps to Complete Additional Resources
Sponsor Staff In ePRO Vault, create and/or manage study, study country, and study site records for the study and assign internal and site users.
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.
Site Staff
  • If local IRB/EC approvals apply, complete that process.
  • If no additional approvals apply, site staff can approve the collection document as soon as they receive it in Veeva ePRO.
Working with Study Versions in ePRO Help for Sites
Site Staff
  • Create study participants and caregivers, if applicable.
  • Enter study participant event dates and times to begin survey schedules.
Onboarding Participants in ePRO Help for Sites
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 Veeva ePRO.
Sponsor Staff and Site Staff Export survey responses, adherence, and system audit trail data.
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 activate the new study version 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 survey 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 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: 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 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.