Manage the ePRO collection documents that your study uses for ePRO.
Note Veeva ePRO is only available to sites conducting a study whose sponsor is utilizing Veeva ePRO in a Clinical Vault.
Overview
An ePRO collection document is a compiled document with information about your study’s ePRO, including:
- Surveys
- Additional details about surveys, if applicable
- Notifications
- Languages supported by your site and their associated translations
- Definitions of ePRO terms
- Sponsor approval date
- Version history and a list of changes, if applicable
The ePRO collection document must be approved before ePRO can be used in your study and it may need to be reviewed by your local IRB/EC, if applicable. Follow the workflows below to download an ePRO collection document, approve the ePRO collection document, and manage new versions of the ePRO collection document in the event of any changes.
Viewing an ePRO Collection Document
To view an ePRO collection document in your browser, complete the following steps:
- In Study Connect, select ePRO on the left menu.
- In the ePRO Collection section of the Overview page, locate the ePRO collection you want to view and select the open icon (
). The document viewer opens in a new window.
Downloading an ePRO Collection Document
To download an ePRO collection document to submit to your local IRB/EC for approval, complete the following steps:
- In Study Connect, select ePRO on the left menu.
- In the ePRO Collection section of the Overview page, locate the ePRO collection you want to download and select the download icon (
). The document automatically begins downloading as a .PDF file.
Approving an ePRO Collection Document
To approve a new ePRO collection document in Study Connect after receiving the applicable regulatory approvals, complete the following steps:
- In Study Connect, select ePRO on the left menu.
- In the ePRO Collection section of the Overview page, locate the ePRO collection you want to approve and select Approve New Version.
- In the Approve New Version pop-up, confirm that the ePRO collection is approved by selecting Approve New Version. The ePRO collection is approved for use, and you can now enable participants with ePRO.
Managing New ePRO Collection Document Versions
When your study’s sponsor updates a study’s ePRO collection to update translations for a language your site supports or to make changes to surveys, schedules, notifications, or events, a new version of the ePRO collection is created in Study Connect. Once it’s created, you must approve this new version in Study Connect before you can assign it to study participants. As a reminder, the changes that your sponsor made in the new version of the ePRO collection may require re-approval by your local IRB.
To upversion an ePRO collection, follow the same steps in the Approving an ePRO Collection Document section using the new version of the ePRO collection document in order to upversion it.
After you approve your study’s upversioned ePRO collection document, active participants who are enabled with ePRO receive the surveys, schedules, notifications, and translations from the upversioned ePRO collection document.
Note If your study’s sponsor adds a new language to a study’s ePRO collection, you don’t receive a new document for approval, but you can add the new language to your study as a supported language. See the Managing Your Study’s Supported Languages help topic for more information.