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.

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.

With the latest Pinnacle 21 Enterprise 3.4 release, we continue to bring efficiencies to your data standardization and compliance efforts. This release features a number of new enhancements and compliance checks that you have been asking for. This release also marks the formal roll-out of our new customer-centric initiative and a dedicated Customer Success Team.

We recently hosted a webinar presenting the new features. You can watch the video, access the slides, review the Q&A, or read the summary below.

Webinar Video

Pinnacle 21 recently hosted a webinar discussing the FDA’s new business rules for clinical data. You can watch the video, access the slides and review the Q&A list.

Webinar Video

December 17, 2016, is less than five months away.

As we all know by now, studies starting on or after that date must be submitted to the Food & Drug Administration electronically. They must also utilize the most-recent FDA-acknowledged version of data standards.

To support the latter point, FDA is requesting that sponsors submit a Study Data Standardization Plan (SDSP) as part of the IND application.

With time running out quickly, two big questions have taken on a new urgency:

On November 24th, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published its first official list of validation rules for CDISC SDTM, ADaM and Define.xml. These long awaited rules cover conformance, reviewability and quality requirements, as described in the PMDA Technical Conformance Guide on Electronic Study Data Submissions. The rules will ensure that data conform to the standards and support ease of use and meaningful analysis.

The PMDA agency is asking sponsors to validate their study data before submission — using these published validation rules — and either correct any validation issues or explain why they could not be corrected in the data guide. PMDA has introduced new “Reject” rules, which, if violated, will cause the review to be suspended until issues are corrected. PMDA can also suspend review if explanations for certain issues are not provided.

When CDISC published Version 1.3 of its ADaM Validation Rules, a lot of you wondered what to make of it.

According to CDISC: “Some checks have been reworded for clarification … [and] 75 new checks have been added to cover rules not previously addressed. [These] additional checks cover the addition of checks for Adverse Events (ADAE) and the ADaM Basic Data Structure for Time-to-Event Analyses (BDS-TTE).”

To paint a clear picture of what all this means, and how the industry should respond, Pinnacle 21 hosted a recent webinar on this topic. The webinar — titled, “ADaM Validation Update from OpenCDISC” — provided an overview of these changes, and shared our experience of the most common issues in ADaM submission data observed across the industry.

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.

It was a long time coming. But, finally, on December 17, 2014, the FDA announced that applications must be submitted electronically, and that submissions will be required to contain study data in conformance with CDISC standards.

The industry has been given 24 months from the publication of the final guidance documents to comply. Not wanting to waste any precious time, Pinnacle 21 hosted two webinars — on January 7th and 8th, 2015 — to help guide you through the new processes.