Designing Library Collections

21R1 & Later

From the Library, librarians can create a new type of Study called a Collection. A collection allows an organization to manage a set of standards isolated from other Studies. Study designers can be given view access to a Collection, but they can’t edit them.

During study creation, study designers can now copy from a library Collection or from an existing Study. When copying from the library, Vault doesn’t include any configuration for Randomization.

Collections use deployment for versioning, and annotated PDFs, the SDS, and the comparison report are available for Collections as they are for regular Studies.

Prerequisites

Required Permissions

Users with the CDMS Librarian study role can perform the actions described below by default. If your organization uses custom Study Roles, your role must grant the following permissions:

Type Permission Label Controls
Standard Tab Library Tab

Ability to access the Library tab
Functional Permission View Library

Ability to view library Collections and their designs from Studio > Library
Functional Permission Design Library

Ability to create study design definitions and a study schedule for a Collection from Studio > Library

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

Learn more about Study Roles.

Accessing Collections

You can access your Collections from the Library sub-tab in Studio. In the top navigation bar, click Studio, then click Library.

Studio > Library

How to Create a Collection

To create a new Collection:

  1. Navigate to Studio > Library.

  2. Click + New Collection. New Collection button

  3. Enter a Name for the _Collection.

  4. Choose an Organization to associate your Collection with. You can select + New Organization to create a new Organization as needed. Select new organization

  5. Optional: Enter an External ID.
  6. Optional: To create this Study as a copy of another Study:
    1. Select From Another Study or From Library for Copy Study Design. Selecting From Another Study allows you to choose a Study to copy, and selecting From Library allows you to select a Collection to copy.
    2. Select the Source Vault.
    3. Select the Source Study.
    4. Select the Study Environment.
    5. Optional: Select the Ignore import casebook version checkbox to ignore the version of the source study and import the copy as version 1. Note that if you selected a template-type vault as the Source Vault, this option is unavailable.
  7. Optional: Choose which environments to create Environments in. These are vaults or sandboxes where you’re housing your user acceptance testing, training, and production environments for your Collection. If you don’t select vaults here, Vault only creates a development environment, and a deployment administrator can create additional environments as needed later.
  8. Click Create.
  9. In the New Study confirmation dialog, click Create. Vault begins a job to create your Study Master, your development Study Environment, and additional Study Environments for all environments that you selected. Depending on your selections, this job may take a few minutes.

Library Report

You can create a vault-level report that shows definitions, their keys, where they originated, and which versions they changed in. The goal of this report is to allow you to identify what objects were sourced from the library and if they were changed since they were copied from the library. The report uses the Cross Vault Unique ID to identify the Source Version and Changed In Version.

The report includes Forms, Item Groups, Items, Codelists, Units, and Rules. Vault creates records when the definition is new to a Study, either by copying it from another study or creating it manually. Vault updates records when they are changed in that version. If a definition was created as the result of a new version, but it wasn’t changed, it reflects the new version.

Note that you can only run the Library Report in DEV environments.

In this release, the report doesn’t roll up changes to the form level, so if further insight is required to understand a deviation, a library may need to leverage a study’s SDS to identify all impacted forms.

To create the library report:

  1. Navigate to your Collection in Studio > Library.

  2. From the Actions menu, select Library Report. Create Library Report action

  3. Optional: Select Create as CSV instead of Excel to create the library report as a CSV file. If not selected, Vault creates the report as an Excel file (.xlsx). Vault automatically uses this format if there are more than 800,000 records in the Definition Histories object.

  4. Click Create.
  5. Vault begins generating the Library Report. When finished, Vault sends an email with a link to download the report.
  6. Click Close.

Library Reports for Pre-21R1 Studies

Vault does not create lineage records for existing Studies. These records may only be created from the release point forward. Organizations can work with Veeva Services to seed library lineage records for existing studies if required, but this is only possible when the existing Study is converted to a library Collection. For these seeded records, Vault creates a change for each version of that converted study. During seeding, users will not be able to create or edit definitions in the collection.