Generate Case Collections from Workbench Case Series

Learn how to generate Case Collections from Workbench Case Series.

About Case Collections from Case Series

In Safety, a Case Collection includes a list of Case Numbers and is used for reporting to partners and relevant health authorities in CIOMS I and E2B(R3) formats. In Workbench, a Workbench Case Series is a set of specific Case versions generated from a Workbench Report. To facilitate Safety reporting using Workbench Report outputs, Workbench allows you to generate Case Collections from a Workbench Case Series.

When you generate a Case Collection from a Workbench Case Series, you can specify one (1) of the following reporting formats:

• CIOMS I Masked
• CIOMS I Unmasked
• ICH E2B(R3)

A Case Collection includes up to 1,000 Cases.

Prerequisite

Your Admin must enable generating Case Collections from Workbench Case Series.

Generate a Case Collection

For Workbench Reports that were run using a Case series-enabled safety view, you can generate Case Collections. To generate a Case Collection from a Workbench Case Series:

1. Navigate to Workbench > Ad Hoc Reports.
2. From the All Actions menu of a Workbench Report with a Case series-enabled safety view, select one (1) of the following actions:
   • Generate CIOMS I Masked Collection
   • Generate CIOMS I Unmasked Collection
   • Generate E2B R3 Collection

Result

Vault sends an email and a notification to alert you when generation is complete with a link to the Case Collection. Vault sets the following on the Case Collection:

• A title named after the Workbench Report from which it was generated
• The object type to one (1) of the following, depending on the action used:
  • CIOMS I PII Masked & Study Blinded
  • CIOMS I PII Unmasked & Study Unblinded
  • E2B R3

The Case Version Setting field is set to Specific Case Version. This value allows the Case Collection to link to a specific version of the Case.