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Electronic Systems: Are Yours Fit for Purpose?
Session Chair(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States
Electronic systems play a critical role in the conduct of clinical trials, but when inadequately validated and maintained to ensure that they are fit for use for their intended purpose, they may significantly impact the quality and reliability of clinical trial data. In this session, we will discuss examples of electronic systems commonly used to conduct clinical trials and expectations for their validation and maintenance. Examples of frequently encountered issues impacting data quality will be presented and discussed. The role of quality assurance, in maintaining oversight of these systems will also be considered. Perspectives from regulators and regulated industry will be provided.
Learning Objective : Discuss the importance of ensuring that electronic systems used to conduct clinical trials are adequately validated and fit for intended purpose; Describe how regulators evaluate electronic systems; Discuss the role of quality assurance in ensuring regulatory compliance of electronic systems used by their organizations.
Speaker(s)
MHRA Perspective
Gail Francis
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Inspector, GCP
FDA Perspective
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
Industry Perspective
Jonathan Andrus, MS
CRIO, United States
President and Chief Operating Officer
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