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.
Registration is now open for the next NJ CDISC User Group meeting, scheduled for Wednesday, January 28, 2015 from 1-5pm. The meeting will be held at TAKE Solutions in Princeton, NJ. Please register by January 20, via the link below:
Register for the NJ CDISC User Group
Meeting Agenda:
- Kevin Lee (Accenture): Standards Metadata Management: Version Control and its Governance
- Fred Hofstetter and Ian Fleming (d-Wise): Leveraging R and Shiny for point and click ADaM Analysis
- Archana Bhaskaran and Kannan Subramanian (Novartis): Metadata Management – Our Journey Thus Far
- Sangeeta Bhattacharya: Trial Design Domains
- Max Kanevsky and Sergiy Sirichenko (Pinnacle 21): FDA Finalizes Requirements for Standardized Data
- Andrew Ndikom (Novartis Vaccines): ADaM Compliant Table Creation Macros
