Working With Collections

Viewing Collections For a Study

The collection supports versioning in the case of protocol amendments or upversions. Select the Collections tab to access the history of collection versions for your study and the following related details:

• 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 Collection statuses include Draft, UAT in Progress, Approved, Superseded, and Deleted.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  • Superseded: The collection was previously approved but has been replaced by a new version. Each site will continue using the superseded version until they activate the most recent version in Veeva eCOA.
  • 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.
• 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 various elements of your study, such as surveys, languages, schedules, and so on.

Complete the following steps to create a new collection:

1. Open Studio from a study in your eCOA 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 ():
   • Delete Collection: You can delete the collection version if created in error. This action is only available for versions after version 1.
   • Copy UAT Setup Code: See (Performing User Acceptance Testing (UAT) on a Collection). This action is only available in sandbox environments.
   • Generate New Overview: See Running Reports.
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 Study Languages and See Managing Collection Languages and Translations Managing Collection Languages and Translations for more information.
   • Rules: Configure which rules you want to create notifications and criteria checks based on survey responses.

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. Hover over the Source dot for the survey. The survey’s source is displayed.

Viewing the Restricted Data Status

When a study contains restricted data that should not be viewed by users unless they have been granted access, you can view the restricted data status in Studio. When the study builder classifies a survey as restricted, the restriction is automatically updated throughout Studio, Study Home, and Veeva eCOA. If the value is ever updated, the restriction setting is also updated across all applications.

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, open the collection, edit the survey, and select Yes, No, or N/A from the Reviewed dropdown.

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, open the collection, edit the survey, and select Yes, No, or N/A from the Licensed dropdown.

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.

3. To download the latest generated overview (if available), from the Actions menu, select Latest Overview.