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Our recent webinar Confusing Validation Rules Explained sparked lots of follow-up questions from you. We are addressing those questions in a series of posts. In this edition, we will clarify the best practices when mapping data for screen failure, not assigned, and not treated subjects. We will also help by describing the most effective ways to respond to these situations.

When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. You can watch the recording below. For webinar slides and frequently asked questions, read on.

When preparing data for regulatory submissions, we know you need to comply with hundreds of validation rules. While many rules are straightforward, some could be confusing. Are you wondering why a certain validation rule fired? If it’s applicable to your study? And whether you should fix it or explain it? These and other commonly asked questions were answered by Pinnacle 21’s Michael Beers in a recently hosted webinar. You can watch the recording below. For webinar slides and frequently asked questions, read on.

On Friday, September 27th, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) published its long-awaited update to validation rules for SDTM, ADAM and Define.xml. PMDA Validation Rules 2.0 introduce additional standard conformance rules from CDISC, support for analysis result metadata (ARM), and many other changes. At Pinnacle 21, we've got you covered. We have released support for these new rules in our latest validation engine.

On Friday, September 27th, the Japanese Pharmaceutical and Medical Devices Agency (PMDA) published its long-awaited update to validation rules for SDTM, ADAM and Define.xml. PMDA Validation Rules 2.0 introduce additional standard conformance rules from CDISC, support for analysis result metadata (ARM), and many other changes.  At Pinnacle 21, we've got you covered.

Define.xml is "arguably the most important part of the electronic dataset submission for regulatory review," according to The FDA’s Technical Conformance Guide. It helps reviewers gain familiarity with study data, its origins and derivations, as well as sponsor-specific implementation of CDISC standards. In addition to the define.xml, the Technical Conformance Guide also asks that sponsors submit a stylesheet. A stylesheet transforms the define.xml into a human readable structure.

(Originally published on March 9, 2016. Last Updated on June 28, 2019)

Have you ever wondered how Pinnacle 21 implements rules for ADaM validation? Below is a list of commonly asked questions.

1. Does Pinnacle 21 implement the validation checks published by CDISC?

   Yes, Pinnacle 21 rules are an implementation of CDISC validation checks. In fact, P21’s Trevor Mankus is a co-lead of the CDISC ADaM Conformance Rules subteam with P21's Michael DiGiantomasso, Michael Beers, and Sergiy Sirichenko as active members. Between 2011 and 2018 the subteam produced 4 versions of CDISC validation checks, with Pinnacle 21 supporting the industry by releasing 7 updates to the open source rule implementations. This close collaboration between Pinnacle 21 developers, ADaM team core members, and representatives from across the industry is what makes it possible to continuously improve rule definitions and implementations. Most recently, the subteam released CDISC ADaM Conformance Rules v2.0 which included support for IG 1.0 and IG 1.1.

2. Why do the message text and rule counts differ?

   CDISC check definitions are designed to serve as requirements to machine implementation, "a programmable test, written such that an affirmative response represents a failure of the requirement. This text is intended for use as a requirement specification which could be implemented in a variety of programming languages". P21's rule messages and descriptions, on the other hand, are designed for the end user to help them quickly identify and fix the cause of validation issue.

We are thrilled to announce that P21 Community 3.0 is available for immediate download.

This is our most ambitious release to date. We added support for new standards and rules, but most importantly we reinvented how the software is released, installed, and kept updated. Let’s take quick tour of the new features.

Released March 31, the new P21 Enterprise 4.0 provides more options for submitting study data to the Japanese health authority PMDA, plus better ways to manage validation issues and reports, as well as new validation rules and support for STDMIG 3.3.

P21 Enterprise 4.0 addresses concerns raised by our customers who submit data to both FDA and PMDA. Historically, regulators at the two agencies have embraced clinical data standards and conformance rules at different rates and degrees of severity.

Running data validations for PMDA has required a separate compliance strategy, plus extra time for validation and regulatory submission. Too often, sponsors worry that PMDA submission packages will fall short of reviewer expectations.