What's New in the 20R2.0.23 Mini-Release

Release Date: September 25, 2020

We are pleased to bring you CDMS in 20R2.0.23 Mini-Release. Read about the new features below. You can find information on enabling new features in the 20R2.0.23 Mini-Release Feature Enablement Details.

Queries

The following are new features to support queries in Vault CDB.

3rd Party Queries

CDB users can now manage discrepancies for third party data sources using queries, as they can with EDC data. With a unified experience, users can now view, create, respond to, and close queries on data items from their study’s third party sources from both the Queries page and the Cell Details panel.

Business Value

When reviewing study data across sources, users may need to identify and resolve discrepant data for third party sources. Users now have one place to create and close all study queries, without needing to return to the third party data source.

Enablement

This feature is available automatically, with no additional configuration required, for Studies that have third party data stored in CDB.

Create, Respond to & Close Queries on Event Dates in the Cell Details Panel

With this release, CDB users can now take query actions on Event Dates within the context of a listing, from the Cell Details panel. From a listing, users can open the Cell Details panel for an Event Date and view any existing queries, respond to them, or close them, as well as create a new query. Prior to this release, CDB users could only perform query actions on Event Dates from the Queries page.

Business Value

Data managers can now review coded terms from Vault Coder in Workbench listings.

Enablement

This feature allows CDB users to quickly review the details of a given data point to better understand its context and take any required cleaning actions.

Export Queries

With this release, CDB users can download all outstanding or closed queries in a Study as a CSV file. The CSV file includes the same columns as the query listing, as well as the sort order.

This feature is especially useful for queries on third party data, but the ability to set the status of a query to Answered (by the vendor) is not available in the current release.

Business Value

When reviewing study data across sources, users may need to share the details of third party queries with vendors in order to reconcile the data. This feature allows them to easily gather all query information from CDB.

Enablement

The ability to download queries to CSV is available automatically. For export, queries must exist within the Study.


Data Export

The following are new features to support data export out of Vault CDB.

SAS Format Exports

CDB users can now choose between CSV and SAS format when generating an export package. For SAS-format exports, CDB creates a SAS file (sas7bdat) for each Export Listing within the Export Definition. Once a SAS-format package is generated, users can click Download () in the Export Definition listing to download the ZIP file.

Business Value

Users often want to be able to export data from CDB in SAS format for use with their organization’s statistics team. They can now easily do so from within CDB.

Enablement

This feature is available automatically, and users can begin generating SAS-format packages from existing Export Definitions or create new ones.


Data Import

The following are new features to support data import from EDC and third party sources into Vault CDB.

Support for Matching on Events in Repeating Event Groups

With this release, non-EDC data that is imported into CDB can now match event instances that are configured in repeating Event Groups (cycles) in EDC using the External ID and the Sequence Number (instance identifier). Events that are repeating in EDC have the same meta definition of the Event External ID (OID) for all instances, whereas other systems treat each instance of the event as its own definition. When importing data for these schedules, users may need to link the data to the proper instances.

Business Value

Users can now match data collected across cycles to the correct Event when importing third party data.

Enablement

This feature is available automatically. CDB users can import data with the appropriate configuration in the manifest file to match events in cycles.


Clinical Query Language

The following are new features for CDB's Clinical Query Language (CQL).

CQL Functions for Coder

With this release, CDB users can create listings that display any terms coded using Vault Coder. For each dictionary, CDB can display the following:

WHODrug Terms MedDRA Terms
  • Drug Name
  • Preferred Name
  • ATC4 Code
  • ATC4
  • ATC3 Code
  • ATC3
  • ATC2 Code
  • ATC2
  • ATC1 Code
  • ATC1
  • LLT Code
  • LLT
  • PT Code
  • PT
  • HLT Code
  • HLT
  • HLGT Code
  • HLGT
  • SOC Code
  • SOC
  • Preferred Name
  • Primary Path

To support listings with coded terms, we added the following CQL functions:

  • CODEDTERM()
  • CODEDCODE()
  • CODEDDICTREL()
  • CODEDSTATUS()
  • CODEDBY()
  • LASTCODED()

Business Value

Data managers can now review coded terms from Vault Coder in Workbench listings.

Enablement

These CQL functions are available automatically, but a user must edit or create a new listing to include them in the CQL statement.

Added @HDR.Subject.Withdrawn Date & Additional @Form.Properties

With this release, data managers can now use CQL to display the following information in listings:

  • Subject Withdrawn Date (@HDR.Subject.WithdrawnDate)
  • Form Created Date (@Form.CreatedDate)
  • Form Submission Date (@Form.SubmissionDate)
  • Form Submission Count (@Form.SubmissionCount)

Business Value

Users can easily access additional metadata for subjects and forms in CDB, without returning to a custom report in EDC.

Enablement

These CQL changes apply automatically, but a user must edit or create a new listing to include them in the CQL statement.