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.
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.
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.
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.
In late 2014, the FDA announced that, starting December 17, 2016, all new clinical and nonclinical studies must be submitted electronically and contain data in conformance with the standards specified in FDA’s Data Catalog. This is part of an effort to accelerate the regulatory review process.
At the time of this writing, that deadline is only nine months away. So, the big question looms: Are you 100% ready for FDA submission? Because when December 17th comes, any doubt you have may represent a risk of slowing down the review process. More importantly, you’ll be missing out on an opportunity to get your new drug to market faster than ever before.
On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules. The release's main goal was to add new business rules for ADAE (Adverse Events) and BDS-TTE (Time-to-Event Analysis), and, at the same time, clean up some of the checks from the prior release.
But these new rules still don’t provide a complete solution. ADaM validation requires the ability to supplement the ADaM rules with sponsor-specific controlled terminology and value level checks ... and the ability to test those checks with the same software used by the FDA.
Through this webinar, we’ll provide an overview of recent changes and share our experience of the most common issues in ADaM submission data observed across the industry. Our speaker will be Pinnacle 21’s Michael DiGiantomasso. Mike serves on the CDISC’s ADaM Validation sub-team and is a Data Fitness Analyst on the FDA JumpStart project.
For your convenience, we’ll be providing this webinar at two different times.
|WEBINAR SESSION 1||WEBINAR SESSION 2|
|Date: Wed, Jun 3, 2015 |
Time: 9:00 am EDT
Length: 1 hour
|Date: Thu, Jun 4, 2015|
Time: 2:00 pm EDT
(11:00 am PDT)
Length: 1 hour
In this webinar, we will cover:
- Review of all ADaM validation rules and categories
- Overview of datasets recognized by OpenCDISC
- Adding sponsor-specific CT and VLM checks
- Common ADaM issues in submission data
- Rules for the upcoming release of ADaM IG v1.1
On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules.
So, what’s changed?
In the simplest terms: the release’s biggest enhancement is the ability to recognize and validate ADAE (Adverse Event Analysis) and BDS-TTE (Time-to-Event Analysis) datasets. CDISC has added 75 new rules in total, and, at the same time, cleaned up some of the checks from the prior release to ensure that their failure criteria is machine-testable.
So, what should concern you?
These published business rules conform to the definition of CDISC’s intention that each rule requirement be broken down into its constituent parts and should be machine-testable. For example, a simple rule which states “C BETWEEN A and B” will be stated as C >= A and C<=B. This normalized model works for business requirement capture … but it can make implementation, testing and human understanding more complicated than they need to be.
Beyond that, these newly enhanced ADaM validation rules still don’t provide a complete solution. Since ADaM IG v1.0, CDISC has been providing mere specifications documents. ADaM validation requires more than that. You need the ability to supplement the ADaM rules with sponsor-specific checks, especially for sponsor defined controlled terminology and value level metadata. And you need to be able to test those checks with the same software used by the FDA.