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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 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

The next meeting of the NJ CDISC User Group will be held on Monday, Feb 27, 2017, 1-5pm at Novartis Pharmaceuticals Corporation, East Hanover campus.
 
If you are interested in attending this meeting (in-person or online), please register by Friday, Feb 10th.

Register for NJ CDISC User Group
 
Planned agenda:

On November 2, Pinnacle 21 was the recipient of the 2016 TOPRA Award for Regulatory Excellence in Innovation. We were excited to be nominated and shortlisted among some incredible competition. We are really thrilled to accept the award this year!

VIDEO: Max Kanevsky's acceptance speech

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.

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:

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 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.

OpenCDISC has begun a rebranding process. The first step in that process, effective immediately, is that our organization will no longer be using the name “OpenCDISC” for any product, service or event.

Going forward, OpenCDISC Community will now be known as Pinnacle 21 Community; and OpenCDISC Enterprise will now be known as Pinnacle 21 Enterprise.

Why? After many years of mutual support and understanding, the CDISC organization has asked us to stop using the name “OpenCDISC.”

What does this mean to you? Ultimately, nothing. The staff at Pinnacle 21 will continue to develop our open source software and make it available to all, free of charge. And we will continue to help and support our users as we always have.