Using a Collection

Use Veeva ePRO Studio to create, view, and edit the survey collections for your study.

Overview

Collections include the following information, which represent your study protocol:

  • 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.

Collections exist 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.

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 ePRO Vault:

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

Viewing Collections For a Study

The collection supports versioning in the case of protocol amendments or upversions. From the Collections list, you can view the history of collection versions for your study and their details, which include:

  • Version: The version number of the collection.
  • Status: The status of the collection. Collection statuses include Draft, UAT in Progress, Approved, Superseded, and Deleted.
    • Draft: The collection hasn’t been approved yet and can be edited or deleted. Approving a draft collection supersedes the version that’s currently approved.
    • UAT in Progress: The collection is in UAT. When you finish the UAT, you can select a verdict of Pass or Fail. If UAT passes, you can approve the collection.
    • Approved: The collection is approved for the study and becomes available for study sites to activate. Only one approved collection can exist for a study at one time.
    • Superseded: The collection was previously approved but has been replaced by a new version. Each site will continue using the superseded version until they activate the most recent version in Veeva ePRO.
    • Deleted: The collection was deleted while still in a draft state. It was never shared with sites or assigned to participants. No other versions were affected. Approved On: The date the collection was approved, if applicable.
  • Surveys: The number of surveys in the collection.
  • Schedules: The number of survey schedules in the collection.
  • Patient and Site Languages: The number of languages in the collection.
    • When all translations for all languages in a collection are uploaded, the value is shown in green font. Hover over the value to see the list of completed languages.
    • When one or more translations for languages in a collection haven’t been uploaded, the value is shown in red font. Hover over the value to see a list of the complete and incomplete languages.
  • Summary of Changes: The summary of changes is provided during upversioning.

Creating a Collection

You can create a collection in the Studio to begin configuring your study’s surveys, languages, schedules, and notifications.

Complete the following steps to create a new collection:

  1. Open Studio Open Studio button from a study in your ePRO Vault.
  2. On the Collections page, select Create New in the top corner.
  3. On the new Collection page, the following actions are available to you from the Actions menu (All Actions button):
  4. The following tabs are available in the left menu:
    • Study Details: The details shared here populate the Study Home screen in MyVeeva for Patients. You can use this space to communicate important study information to participants and upload your study image (e.g. company or study logo).
    • Surveys: Manage your current list of surveys or add new surveys by creating new or adding from a library or creating from scratch. See Configuring Surveys Configuring Surveys for more information.
    • Groups: Manage the group types that allow you to send surveys to different sets of participants. See Managing Groups Managing Groups for more information.
    • Events: Create and manage study events to designate the visits and study milestones at which surveys are assigned to participants and site staff. See Managing Events Managing Events for more information.
    • Languages: Configure which languages are available for your collection and manage their translations. See Managing Languages and Translations Managing Languages and Translations for more information.

Viewing the Source of a Survey

To see if a survey in your collection was sourced from the Veeva Library, your customer library, or is specific to your study, complete the following steps:

  1. Open a collection.
  2. In the Surveys tab, find the Source column.
  3. In the Source column, hover over the dot for the survey. The survey’s source is displayed.

Tracking Reviewed Surveys

When a survey requires review from the agency or practitioner who owns it before it can be used in your study, you can track its review status in Studio. Surveys added from a library inherit the value of the field in the library survey. Generally, once a survey has been reviewed by an agency or practitioner, it doesn’t need to be reviewed again for use in a new study; however, contact the agency or practitioner to confirm.

To change the review status for a survey, complete the following steps:

  1. Open a collection.
  2. In the Surveys tab, locate the Reviewed column.
  3. In the Reviewed column of the survey, select Yes, No, or N/A.

Tracking Licensed Surveys

When a survey requires licensing from an agency or practitioner for its use in your study, you can track its license status in Studio. Generally, a survey owned by an agency or practitioner needs to be licensed for each new study using it. By selecting a Licensed status of Yes, you attest that you obtained a license for the survey.

To change the license status for a survey, complete the following steps:

  1. Navigate to a collection.
  2. In the Surveys tab, locate the Licensed column.
  3. In the Licensed column of the survey, select Yes, No, or N/A.

Exporting PDF Overviews of a Collection

You can generate and export a .ZIP file of PDF overviews containing information about your study’s surveys, including:

  • ePRO surveys
  • eClinRO surveys
  • Additional details about surveys, if applicable
  • Survey preview links
  • Notifications
  • Languages supported by the study and their associated translations
  • Definitions of terms, if applicable
  • Approval date, if applicable
  • Version history table and a list of changes, if applicable
  • Study Home preview
  • Separate PDF files for each language supported by the study, with the translated content. The source English content is always included for comparison.

This overview can be used to aid your study’s local or central IRB or EC approval as it contains all the participant-facing study content.

Complete the following steps to generate and export a .ZIP file of PDF overviews:

  1. Select a collection version from the Collections list.
  2. To generate a new overview, from the Actions menu, select Generate New Overview.
  1. To download the latest generated overview (if available), from the Actions menu, select Latest Overview.