Validation

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The previous, outdated version of the validation rules is represented by our “FDA Legacy (1903.1)” engine.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.

Our recent webinar  Confusing Validation Rules Explained generated lots of follow-up questions from you. We are addressing those questions in a series of posts. In this edition, we will clarify the meaning and purpose of the duplicate records validation rules, then answer some frequently asked questions about duplicate records.

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.

(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.

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.

Last week, FDA published an updated version of Validator Rules for study data. There are many changes which we have reviewed and summarized for you.

The first change you’ll notice is that there are a number of new columns:

• FDA Validator Rule ID – a unique rule id that is now consistent across FDA, PMDA, and Pinnacle 21
• FDA Validator Message – validation messages produced by the Validator
• Publisher – the source of the business or conformance rule, FDA or CDISC

The FDA list now includes the conformance rules published by CDISC, which is the why the list has grown by 317 rules, from 163 to 480. The CDISC rule ids can be found in the Publisher ID column.

Next, the FDA added a reference to SEND-IG 3.1 to show how existing business and conformance rules apply to this standard. CDISC is still working on the conformance rules for SEND-IG 3.0 and 3.1, so this list could serve as a guide for implementers for the time being.

So how does this release effect you?

With the December 17th deadline drawing near, we are happy to announce several important and timely updates to our platform.

The FDA mandate goes into effect in only 80 days, at which point all new submissions will be required in standardized, electronic format. These new Pinnacle 21 tools will help you meet those demands quickly and confidently.

What’s new:

Validate Analysis Results Metadata (ARM)

Analysis Results Metadata provides traceability from results in a statistical display to the data in the analysis datasets. It helps regulatory reviewers understand and reproduce analysis results, which is why both FDA and PMDA are interested in ARM being included in Define.xml. Now you can ensure that your ARM metadata is compliant and ready for submission.