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The adoption of risk-based CDM approaches

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  • Paulina Linares
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The adoption of risk-based CDM approaches

A topic brief by the SCDM Innovation Committee

Regulators have issued guidance documents advocating for the use of risk-based and fit for purpose approaches over a decade ago. The Good Clinical Practice guidance (i.e., ICH E6) was updated in 2016 to reinforce the direction and introduce Quality Tolerance Limits (QTLs). More recently, the long-awaited guidance on General Considerations for Clinical Studies (ICH E8) is further clarifying the expectations by focusing on two foundational risk-based principles which are Quality by Design (QbD) and Critical to Quality (CtQ) Factors.

Many of those principles apply directly to Clinical Data Management. If you are waiting for some directions to shift your Clinical Data Management strategy toward risk-based processes, this topic brief is a good place to start.

Download Topic Brief


Meet the Authors

CDS topic Brief Authors

  • Catherine Célingant, Executive Director, Data Monitoring & Management – Oncology, Pfizer
  • Lynne Cesario, Global Risk Based Monitoring Program Lead, Pfizer
  • Patrick Nadolny, Global head, Clinical Data Management, Sanofi

Reviewers and Contributors

  • Sanjay Bhardwaj, Head of Clinical Technology Strategy & Operations, Abbvie
  • Joanna Florek-Marwitz, Head Risk Management and Data Quality, UCB
  • Jérémy Nadolny, Sr Business Associate, Trial Operations
  • Peter Stokman, Business Lead Data Review & Visualization, Bayer
  • Demetris Zambas, Global Head, Data Monitoring & Management, Pfizer

Upcoming releases:

August 9, 2022 | The CDM Role Evolution
September 1, 2022 | How to evolve Clinical Data Management into Clinical Data Science

Find Out More

Author: Paulina Linares

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