Generating Study Closeout PDFs for Sites

Once your site finishes data collection, data review activities are complete, and you have locked the site, you can begin closing out the site. Vault generates closeout PDFs (a ZIP file containing a Detail PDF for each Subject at the Site) from within EDC Tools. After you generate the closeout PDFs, you can send them to the site for review. You can also choose to send sites periodic reminders until they finish their review.

You can only begin closeout once a Site is locked. If you unlock a site and closeout is already complete, unlocking resets the closeout status. You will have to repeat the process.

After database lock and study closeout, your Study can remain in your vault as long as your organization would like it to remain. At any time, you can request that your Study be removed from your vault. Contact your Veeva Services representative to do so.

Generate Closeout PDFs

To generate a closeout PDF:

1. Navigate to EDC Tools > Sites.
2. Locate the Site you want to close out in the list.
3. Hover over the Site to show the Actions menu.

4. From the Actions menu, choose Generate Closeout PDFs.

5. Click Generate. Vault begins a job to create the closeout PDFs for this site. You can monitor the progress of the job from EDC Tools > Job History.

You can download the closeout PDFs for a Site from EDC Tools > Sites. This is the same ZIP file that your site users will download. Note that if the user generating the PDF does not have Restricted Data Access permission and the casebook doesn’t contain any Restricted forms, only a non-restricted version of the closeout PDF will be generated. Closeout PDFs that contain restricted data will be marked as Restricted.

To download a site’s closeout PDFs:

1. Navigate to EDC Tools > Sites.
2. Locate the Site you want to download the closeout PDFs for in the list.
3. Hover over the Site to show the Actions menu.
4. From the Actions menu, choose Download Closeout PDFs. Vault downloads a ZIP file containing the closeout PDF for each Subject at the Site.

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

How to Notify Sites & Set Reminders

To allow your site users to access closeout PDFs, you must notify them. Notifying the site sends site users an email notification and makes the PDFs available for download in the Data Entry tab.

Note that to send site notifications, you must first generate the closeout PDFs.

To notify sites:

1. Navigate to EDC Tools > Sites.
2. Locate the Site you want to notify in the list.
3. Hover over the Site to show the Actions menu.

4. From the Actions menu, choose Notify Site.

5. Optional: By default, Vault will send an email reminder every 10 days. You can enter a new number to send an email every so many days, or you can clear this checkbox to not send reminder emails.

6. Click Notify.

Stop Scheduled Reminders

To stop scheduled reminders:

1. Locate the Site you want to remind in EDC Tools > Sites.

2. In the Closeout Status column for that Site, click Show closeout activity ().

3. In the Closeout Activity dialog, click Stop Reminders.
4. Click Stop Reminders.

Send Ad Hoc Reminders

You can send ad hoc reminders, in addition to scheduled ones, when the site’s closeout status is Awaiting Site Response.

To send an ad hoc reminder:

1. Locate the Site you want to remind in EDC Tools > Sites.
2. In the Closeout Status column for that Site, click Show closeout activity ().

3. In the Closeout Activity dialog, click Send Reminder Now.

4. Optional: In the Send Reminder dialog, update the selections to change who receives the notification. By default, Vault sends the reminder to both reviewers and approvers.

5. Click Send Reminder.

Closeout & Custom Study Roles

By default, the CDMS Principal Investigator and CDMS Clinical Research Coordinator study roles have permissions to review and accept closeout PDFs. If your organization uses custom Study Roles, assign the appropriate roles the permissions below to allow them to review closeout PDFs:

Note that you can assign a role the Review Closeout PDFs without assigning Accept Closeout PDFs. This allows the user to download any closeout PDFs for their site but not accept or reject them.

Learn how to create custom Study Roles.