Validation

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.

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.

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

Best regards.
OpenCDISC Team

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.