Exporting Casebook Data as a PDF

In Veeva EDC, you can export your subject’s Casebook to a PDF to print, use as a reference, etc.

Prerequisites

Required Permissions

Users with a standard Application Role and Security Profile can export PDFs from the areas of the application that they have access to (Investigators from the Data Entry tab, CRAs from the Review tab, etc.). CDMS Clinical Coders, CDMS Clinical Coder Administrators, and CDMS User Administrators do not have access to export PDFs. If your vault uses custom Application Roles, your role must have the following permissions:

Type Permission Label Controls
Functional Permission Generate Blank PDF

Ability to export blank PDFs
Functional Permission Generate Detail PDF

Ability to export detail PDFs

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

Learn more about Study Roles.

Available PDFs

You can export two (2) different types of PDFs for Forms and Casebooks in your Study.

  • Blank PDFs that have no data.
  • Detail PDFs that have all entered study data.

For Detail PDFs, you can choose whether to include queries, audit trail information, or both.

At the Form-level, the PDF includes the Form, as well as the name of the Study, Event, and Form in a header. If you exported a detail PDF with queries, the PDF also includes sections for audit information and queries.

At the Casebook-level, the PDF includes all Forms in the Casebook, ordered by Event, as well as Study and Subject information in the header. The Event and Form records inside the casebook are bookmarked in the PDF with an option to view By Visit or By Form through the enhanced Detail PDF feature.

PDF Language: Detail and Blank PDFs are available in the language that is set on your user profile. PDFs are translatable, however, only standard text will be translated. Configured labels or entered text will not be translated.

Detail PDF

In 19R3, we introduced an enhanced version of Detail PDFs. These PDFs are easier to navigate and provide additional information required for submission. Enhanced Detail PDFs are available for both forms and entire casebooks.

Depending on the date your Study was created, you may need to enable this feature in order to perform the actions described below.

To enable the Enhanced Detail PDF feature, you must update the Study Configuration record for each Study you want to use this feature in.

  1. Navigate to Admin > Business Admin > Study Configurations.
  2. Locate your study’s Study Configuration record in the list.
  3. Click to open your study’s record.
  4. Click Edit.
  5. Enter “2” in the PDF Format Version field.
  6. Click Save.

File Size Limit: Detail PDFs are limited to 4GB in size.

How to Export a PDF

To export a PDF:

  1. Navigate to the Casebook or Form you want to generate a PDF from.

  2. From the Actions menu, choose Export Blank PDF to export a blank PDF, without entered data. Choose Detail PDF to include data. Export Blank PDF and Detail PDF Options in the Event-Level Actions Menu

  3. For Detail PDFs, select from the options in the Detail PDF Options dialog and click Continue to export. Detailed PDF Options

  4. Vault begins generating your PDF. When finished, Vault begins the download automatically.

Export a PDF for All Subjects in a Site

You can export a detail PDF or a detail PDF with queries from the EDC Tools > Jobs tab. You can choose to export PDFs for a single Site, a selection of Sites, or all Sites in your Study (closeout PDF). Note that this area of the application is only visible to users with the EDC: Study Tools: Access permission. See Managing Jobs in EDC Tools for details.

Sort By Visit & By Form

You can view Events by visit by selecting By Visit in the PDF bookmark section. In this view, you will see all subject events ordered by study design and containing all forms corresponding to that event. Use the By Form bookmark to organize forms alphabetically.