ADaM

On November 29th, CDISC released updated versions of SDTM and ADaM, including standardized structures for medical devices and new non-compartmental analysis data.

Moving to new versions of standards is always a challenge and requires planning. Pinnacle 21's subject matter experts Trevor Mankus and Michael Beers summarized key changes and answered industry questions in this webinar and the discussion below, so you can better prepare to up-version your study data.

P21 Validation Engine Improvements

Regulatory Expectations

These Data Standards Catalogs from the FDA and PMDA show the valid ADaM-IG versions for your submission’s date.

• FDA currently accepts ADaM-IG 1.0 and ADaM-IG 1.1.
  • Note: ADaM-IG 1.0 is only accepted for studies that began prior to the dates below. If your study started on or after these dates, then you can no longer use ADaM-IG 1.0 to submit that study.
    • 03/15/2019 for NDAs, ANDAs, and certain BLAs
    • 03/15/2020 for certain INDs
• PMDA currently accepts ADaM-IG 1.0 only. Note: Unlike the FDA, the PMDA does not grant exceptions for issues in the Reject category.

Intro to ADaM Conformance

ADaM data are required by the FDA and PMDA, and accepted by China’s NMPA. Agencies often begin reviews with ADaM data validation, which helps them understand the analyses performed and reproduce results.

This is the first in a series of posts where we answer questions from our recent webinar, Exploring Common CDISC ADaM Conformance Findings. In this post, we focus on implementation recommendations.

In the regulatory review process, it's critical to have analysis data that comply with the CDISC ADaM standard. Both the FDA and PMDA require ADaM data, and as they begin reviews, they start with ADaM data validation. ADaM data help these agencies understand the analyses performed and reproduce the results for further validation.

In this webinar, Trevor Mankus covers the more commonly occurring validation rules and some potential reasons why they fired.

(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.

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

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.