Reviewing Site Closeout PDFs

Once your site finishes data collection and data review activities are complete, your lead data manager will begin to closeout your site. Part of this process includes sending you a PDF version of all Forms collected at your Site, which you must then review and either accept or reject. PDFs will remain accessible, and notifications will continue to be sent until you accept or reject them. There is no time limit. Your lead data manager sets the notification schedule. Your site will also retain these PDFs as a record for some time to meet regulatory requirements.

Once your Site is locked and the Closeout PDFs are available, you will receive a notification and see the Site Closeout banner on the site’s Casebooks listing page.

Optimized for Fast Web View: Closeout PDFs are optimized for Fast Web View.

Prerequisites

Configuration

Your Study must have a Signature Definition of Study Closeout type.

Required Permissions

The actions described below are automatically available to users with the CDMS Principal Investigator and CDMS Clinical Research Coordinator study roles. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Data Entry Tab

Ability to access the Data Entry tab
Functional Permission Review Closeout PDF

Ability to download the Closeout PDFs for a Site
Functional Permission Accept Closeout PDF

Ability to accept or reject Closeout PDFs

If your Study contains restricted data, you must have the Restricted Data Access permission to view it.

Learn more about Study Roles.

Site Closeout PDF Contents

When you close out a site, a Closeout PDF is generated that contains the closeout PDF for each Subject at the site. If the user generating the PDF does not have Restricted Data Access permission or if the casebook doesn’t contain any Restricted forms, only a non-restricted version of the closeout PDF will be generated. A Closeout PDF that contains restricted data will be marked as Restricted, in which case site users must have Restricted Data Access to download it. Closeout PDFs contains the following information:

  • Event Schedule
  • Data
  • Casebook Audit Trail
  • Form Audit Trail
  • Item Audit Trail
  • Event Audit Trail

Download the Closeout PDFs

You will receive a notification when your site’s Closeout PDFs are ready for you to review. Once you receive this notification, you can download the PDF from within Vault CDMS.

Limitations on Generating Closeout PDFs with Audit Trail: Vault does not process Closeout PDF with Audit Trail generation jobs for casebooks that contain more than 20,000 items. If the Study or Site includes a casebook that exceeds this threshold limit, Vault omits the casebook from the Study or Site Closeout PDF.

To download the closeout PDF:

  1. Navigate to your Site from the Data Entry tab.
  2. In the Closeout CRF PDFs banner, click Download
  3. Vault adds your name, the date, and the time to the Closeout CRF PDFs banner and begins downloading a ZIP file containing the closeout PDF. When the download finishes, you can extract the PDFs and review them in a tool of your choosing.

Once you finish reviewing the PDFs, if you have permission to accept or reject them, you can do so from Vault CDMS.

How to Accept Closeout PDFs

To accept the closeout PDFs:

  1. Navigate to your Site from the Data Entry tab.
  2. In the Closeout CRF PDFs banner, click Accept.
  3. In the Accept Closeout PDFs dialog, enter your User Name and Password to electronically sign your acceptance.
  4. Click Accept.

Vault records your acceptance and signature and updates your site’s closeout status to Accepted by Site.

How to Reject Closeout PDFs

To reject the closeout PDFs:

  1. Navigate to your Site from the Data Entry tab.
  2. In the Closeout CRF PDFs banner, click Reject.
  3. In the Reject Closeout PDFs dialog, enter a Rejection Reason.
  4. Click Reject.

Vault records your rejection, updates your site’s closeout status to Rejected by Site, and notifies your organization’s lead data manager.

Restricted Data

For Sites that include restricted data, in which the closeout PDF was generated by a user with access to restricted data, if you don’t have the Restricted Data Access permission, you won’t be able to download, accept, or review the closeout PDF. Closeout PDFs that contain restricted data will be marked as Restricted. Only a non-restricted version of the closeout PDF will be generated if the casebook doesn’t contain restricted forms and if the user generating the PDF doesn’t have restricted data access.