September 2020

CDISC ADaM Implementation Recommendations

September 28, 2020

Intro to ADaM Conformance

ADaM data are required by the FDA and PMDA, and accepted by China’s NMPA. Agencies often begin reviews with ADaM data validation, which helps them understand the analyses performed and reproduce results.

This is the first in a series of posts where we answer questions from our recent webinar, Exploring Common CDISC ADaM Conformance Findings. In this post, we focus on implementation recommendations.

Exploring Common CDISC ADaM Conformance Findings

September 16, 2020

In the regulatory review process, it's critical to have analysis data that comply with the CDISC ADaM standard. Both the FDA and PMDA require ADaM data, and as they begin reviews, they start with ADaM data validation. ADaM data help these agencies understand the analyses performed and reproduce the results for further validation.

In this webinar, Trevor Mankus covers the more commonly occurring validation rules and some potential reasons why they fired.

New Pinnacle 21 Community Validation Engine: FDA (1907.2)

September 13, 2020

In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing study data for FDA submissions. It includes the validation rules currently used by FDA’s DataFit, the agency’s implementation of Pinnacle 21 Enterprise.

The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine. It will be available for the next few months until our next release. This window allows you to finalize your ongoing submission preparations.

Formatting Annotated Case Report Forms (aCRFs): Part 2

September 10, 2020

Tables of Contents and Bookmarks

A table of contents with hyperlinks to bookmarked pages is seen in CDISC's sample aCRF (avaliable in the Define-XML v2.0 download). Both the Metadata Submission Guidelines (MSG) from CDISC and the PDF specifications from the FDA require aCRFs to have hyperlinks to bookmarked pages. The PDF specifications also require a table of contents.