P21E 6.3.0 introduces bi-directional source metadata to SDTM mapping, form specs, spec extensions and other improvements to streamline workflows in P21 Enterprise's foundational and advanced tier Data Exchange and Metadata Repository modules. Check out what a difference 16 New Features, 13 Improvements, 9 Refinements, and 23 Bug Fixes across all P21E modules will make for your team.

To read the complete release notes for P21E 6.3.0, download the file attachment at the bottom of this article. To view the most noticeable changes that impact your user experience, skip the download and check out the Release Highlights below.

Check out the latest additions and improvements to P21E's advanced modules:

Maintaining clear, auditable documentation and traceability from source data to final SDTM variables and ensuring every mapping decision is justified for regulatory compliance is critical. The average study, now comprised of seven different data sources, contains increasingly varied and complex data, and compliance with CDISC SDTM standards is non-negotiable for regulatory submissions to the FDA and PMDA.

So, how do we tackle complexity in mapping? Traditionally done via spreadsheets, mapping SDTM specs has been a slow and error-prone process that delays analysis and submission. Now there’s a better way, built on the principle of “define once and reuse again and again.”

Ditch the spreadsheets. Create and manage your SDTM mapping specs in a collaborative, purpose-built workspace.

P21E allows users to create Form Specs at the global or study level. This allows users to reference global Form Specs during the study-level form spec creation process to ensure specs adhere to CDISC Implementation Guidelines or their company specifications.

We have introduced a new Data Package Type named "Form," enabling you to create and build Study-specific Form Specifications from the Metadata > Forms menu.

Regardless of whether a Form Spec is created by extending or by importing a file, P21E provides users the ability to update and add to new Form Specs quickly and easily. Right-clicking in an editable cell provides you with several options to make specific changes manually.

Use the in-cell wizard to grab elements from existing Standard and Study level forms to jumpstart populating Form Specs, add or remove rows, and track and compare edits, deviations, and versions.

And just like the P21E Spec Chat feature, colleagues can chat in specific cells, fostering transparent decision-making and documenting decisions for easy reference.

Using spec extensions, especially in the context of CDISC standards like SDTM, offers significant advantages in clinical research and regulatory submissions when it comes to handling unique data and study designs. Clinical studies can be highly diverse, especially with evolving scientific needs and complex study designs. When standard CDISC domains don't fully capture specific data points or study elements, extensions allow for the inclusion of these unique elements.

P21E’s Spec Extension features ensure novel data is organized and presented in a consistent, standardized way, minimizing ambiguity for regulatory reviewers and reducing the potential for misinterpretation.

By building and maintaining Spec Extensions in P21E, you’ll preserve a clear, automated audit trail. Well-designed extensions, paired with robust documentation, contribute to traceability, ensuring a clear link between collected data, transformations, and final analysis results.