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
You can view the ePRO collection document automatically created by your study’s sponsor in SiteVault. 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.
Downloading an ePRO Collection Document
To download an ePRO collection document to submit to your local IRB for approval, complete the following steps:
- Navigate to the Documents tab and select Library.
- Use the Study Selector to narrow results to your study.
- Locate the ePRO collection document in your filtered results, or use the search bar to search for the ePRO collection document in your filtered results.
- Select the ePRO collection document for your study.
- From the document page, select the PDF icon (
) on the top right-hand corner of the page. Your document automatically begins downloading.
Approving an ePRO Collection Document
To approve a new ePRO collection document after receiving local IRB approval, complete the following steps:
- Navigate to the Documents tab and select Library.
- Use the Study Selector to narrow results to your study.
- Locate the ePRO collection document in your filtered results, or use the search bar to search for the ePRO collection document in your filtered results.
- Select the ePRO collection document for your study.
- From the document page, select the workflow actions icon (
) and select Change State to Approved for Use. The ePRO collection is approved for use, and you can now enable participants with ePRO.
You should only select this status if the ePRO collection for the study has been approved by your local IRB, if applicable.
Upversioning an ePRO Collection Document
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 SiteVault. Once it’s created, you must approve this new version in SiteVault 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 ePRO Languages For Your Site and Study help topic for more information.