Overview

A collection document is a compiled document with information about your study’s surveys, including:

• ePRO Surveys (eClinRO surveys are not included)
• Additional details about surveys, if applicable
• Survey preview links
• Notifications
• Languages supported by your site and their associated translations
• Definitions of survey terms
• Sponsor approval date
• Version history and a list of changes, if applicable

The collection document must be approved before surveys can be used in your study and it may need to be reviewed by your local IRB/EC, if applicable. Studies using only site surveys do not rqeuire collection document approval. Follow the workflows below to download a collection document, approve a collection document, and manage new versions of a collection document in the event of any changes.

Viewing a Collection Document

To view a collection document in your browser, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. In the Collection section of the Overview page, locate the collection you want to view and select the open icon (). The document viewer opens in a new window.

Downloading a Collection Document

To download a collection document to submit to your local IRB/EC for approval, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. In the Collection section of the Overview page, locate the collection you want to download and select the download icon (). The document automatically begins downloading as a .PDF file.

Approving a Collection Document

To approve a new collection document in Study Connect after receiving the applicable regulatory approvals, complete the following steps:

1. In Study Connect, select Surveys on the left menu.
2. In the Collection section of the Overview page, locate the collection you want to approve and select Approve New Version.
3. In the Approve New Version pop-up, confirm that the collection is approved by selecting Approve New Version. The collection is approved for use, and you can now enable participants with ePRO.

Managing New Collection Document Versions

When a sponsor updates a study’s collection to update translations for a language your site supports or to make changes to participant surveys, schedules, notifications, or events, a new version of the collection document is created in Study Connect. Once it’s created, you must approve this new version in Study Connect in order for surveys to be available for completion.

As a reminder:

• The changes that your sponsor made in the new version of the collection may require re-approval by your local IRB.
• If the collection only contains site surveys, you do not have to approve the new version.

To upversion a collection, follow the same steps in the Approving a Collection Document section using the new version of the collection document in order to upversion it. After you approve your study’s upversioned collection document, active participants who are enabled with ePRO receive the surveys, schedules, notifications, and translations from the upversioned collection document.