Managing ePRO Collection Documents

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
  • 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. It may need to be reviewed and approved by your local IRB before you approve it for use in SiteVault. Follow the workflows below to download an ePRO collection document to submit to your local IRB, approve the ePRO collection document in SiteVault after receiving local IRB approval, and upversion an 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:

  1. Navigate to the Documents tab and select Library.
  2. Use the Study Selector to narrow results to your study.
  3. 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.
  4. Select the ePRO collection document for your study.
  5. From the document page, select the PDF icon (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:

  1. Navigate to the Documents tab and select Library.
  2. Use the Study Selector to narrow results to your study.
  3. 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.
  4. Select the ePRO collection document for your study.
  5. From the document page, select the workflow actions icon (Workflow Actions icon) and select Change State to Approved for Use. You should only select this status if the ePRO collection for the study has been approved by your local IRB, if applicable.

Change State to Approved for Use image

Upversioning an ePRO Collection Document

When your study’s sponsor updates a study’s ePRO collection due to protocol amendments or other changes, a new version of the ePRO collection is created in SiteVault. Once created, this new version must be approved in SiteVault before it’s assigned 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.


Managing ePRO Languages For Your Site and Study
Enabling and Disabling ePRO for a Participant
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