Seeking Validation: Verified or Truly Vetted? Challenges on the Path to Regulatory Approval

About this session

Part of Session 6, Track A: Foundational Standards - Validation/Quality (Chair: Harivardhan Jampala, Sumitomo Pharma).

Regulatory approval remains the ultimate goal for the majority of clinical trials, yet what appears complete at first glance may not fully withstand regulatory scrutiny. While implementation of CDISC standards has increased yearly and standards compliance has significantly improved, approval cannot be guaranteed based solely on standards and regulatory conformance.
Validation plays a critical role in confirming datasets meet predefined structural requirements. However, while rule-based checks ensure compliance, they may not reveal flaws in other aspects critical for regulatory review.
This presentation will examine common challenges encountered on the path to regulatory approval and consider how these challenges extend beyond traditional validation. The benefits of standardization in enabling consistency and interoperability will be highlighted, alongside areas where additional focus is needed. Finally, potential solutions will be explored, moving us beyond the illusion that CDISC and regulatory conformance alone ensure approval and closer to revealing workflows to truly vet our submissions.

Speakers

• 

  Julie Ann Hood

  Principal CDISC Consultant · Pinnacle 21 by Certara

  Speaker

• HJ

  Harivardhan Jampala

  Sumitomo Pharma

  Chair