Using Studio

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: Determine who gets which surveys or events.
  • Languages and Translations: Track and maintain which languages are permitted and whether the required material is translated.
  • Schedules and Notifications: Create schedules using standard events or events you add, and create notifications for surveys.
  • Study Details: Provide a study description and image for the MyVeeva for Patients app.

Collection versions are created in a draft state until they are approved. Only approved collections are shared with sites and assigned to MyVeeva Users 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.

Opening Studio

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

Complete the following steps to access Studio from your eCOA Vault:

  1. Open the study record.
  2. From the All Actions menu, select Open Studio.

Viewing and Managing Study Settings

Study Settings are the items related to the study that do not require updates as part of collection versions. Select the Study Settings tab to access the following settings:

  • General

  • Study Conduct

    • Data Changes: Define whether site staff can update incorrect survey data or remove surveys submitted in error. See Managing Survey Data Change Permissions for more information.

    • Site Signatures: Require investigator review and endorsement of survey data with an electronic signature. See Managing Site Signatures for more information.

  • Authentication & Identity

    • Participant ID Format: Configure the system to enforce a specific format for Participant IDs when site staff create participants. See Managing the Participant ID Format for more information.

    • In-Person Access: Enable or disable the in-person workflow that allows participants to respond to surveys without setting up a MyVeeva for Patients account. See Managing In Person Survey Access for more information.

Viewing and Managing Exports

The Exports tab includes all available reports for the study. Select the Exports tab to access the following export settings:

  • Custom Exports: Create custom data exports by selecting columns, renaming column headings, and configuring filtering and sorting preferences. Include the custom exports in export jobs or make them available in Study Home. See Working with Custom Exports for more information.

  • Export Jobs: Configure up to 10 FTP connections per study, including one CDB Connection. See Using File Transfer Protocol (FTP) Connections to Export Jobs for more information.

  • Outbound APIs: You can add credentials for external API calls (such as Veeva EDC) and view a log of outbound API activity. See Creating a Send Survey Data Rule Template for more information.

Workflow Overview

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

User Role Application Action Description Steps to Complete Additional Resources
Sponsor Staff eCOA Vault Study, Study Country, and Study Site Record Creation Create and/or manage study, study country, and study site records for the study and assign internal and site users.
Sponsor Staff Studio Collection Creation Create and edit a collection for a study by creating surveys or importing surveys from a library.
Sponsor Staff Studio Languages and Translation Additions Add languages and survey translations necessary for the study.
Sponsor Staff Studio Study Event Creation Add study events to reflect the schedule of events in the study protocol. Managing Events
Sponsor Staff Studio Schedule and Notification Creation Add schedules and notifications for surveys using the study events you created.
Sponsor Staff Studio Study Design Specification Export Generate a .PDF file of the study build to help with a comprehensive study review.
  • Generating the Study Design Specification section on the Working with Collections page
  • Understanding the Study Design Specification
    		•
    Sponsor Staff Studio Screenshot Report Download a .PDF report of the screenshots to aid a study's IRB/EC submissions Exporting PDF Overviews of a Collection
    Sponsor Staff Studio UAT Testing Perform user acceptance testing (UAT) on a collection and approve it for use.
    Sponsor Staff Studio Collection Deployment Deploy the collection to sites for use. Deploying Collections to Sites
    Site Staff eCOA IRB/EC Approval and Study Version Activation
    • If local IRB/EC approvals apply, complete that process.
    • If no additional approvals apply, site staff can activate the study version as soon as they receive it in Veeva eCOA.
    		 Activating Study Versions in eCOA Help for Sites
    Site Staff eCOA Onboarding Participants
    • Create study participants and caregivers, if applicable.
    • Enter study participant event dates and times to begin survey schedules.
    		 Onboarding Participants in eCOA Help for Sites
    Participants, Caregivers, and Site Staff MyVeeva for Patients, eCOA Survey Completion
    • Participants and/or caregivers complete and submit their assigned surveys through MyVeeva for Patients.
    • Site staff complete and submit assigned surveys through Veeva eCOA.
    Sponsor Staff and Site Staff Studio, Study Home, eCOA Report and Audit Trail Generation Create custom exports and export standard reports, audit trail data, criteria check information, and custom reports.
    Sponsor Staff and Site Staff Studio, eCOA New Collection Versions
    • Sponsor/CRO Staff: Create a new version of a collection for a study in the event of changes such as protocol amendments or the addition of languages.
    • Site Staff: After Sponsor/CRO UAT approval, activate the new study version to begin using it if the new version affects supported languages or makes global changes to the collection, such as adding new surveys, notifications, or events.
    </ul>
    Site Investigator eCOA Survey Data Signatures Sign surveys to confirm data review and accuracy if configured for the survey. Providing Signatures in eCOA Help for Sites
    Sponsor Staff and Site Staff eCOA Vault, eCOA End-of-Study Media Finalization
    • Sponsor/CRO Staff: Generate and distribute end-of-study media to sites. Approval status is tracked in eCOA Vault.
    • Site Staff: Review the end-of-study media and approve it in eCOA.

    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:

    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. See Using Survey Libraries for more information.
    • Create and Import from Your Customer Library: If you are configuring a survey that may be used in multiple studies, configure the survey in the Library Manager and import it to the study.
      • Library surveys can be created, managed, and have new versions created through Library Manager.
      • Store translations in Library Manager and import them to studies. If a library survey is translated to a new language for a particular study, download the translation file from Library Manager to ensure that the translation can be reused.
      • See Using Library Manager for more information.
    • 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.

    Order of Operations

    We recommend building a collection in the following order to ensure that dependencies are met:

    1. Surveys
    2. Groups, if needed
    3. Events
    4. Schedules
    5. Rules, if needed. All previous items can be referenced in rules.
    6. Language translations. All previous items may affect translations.

    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) above the JSON editor. See the Previewing a Survey section on the Configuring Surveys page 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.