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Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability
Session Chair(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States
Best practices for development and maintenance of IRT systems will be discussed. Examples of systems that were inadequately developed resulting in significant impacts on study conduct, data quality, and data reliability will be presented.
Learning Objective : Describe the importance of ensuring that interactive response systems (IRT) used to conduct clinical trials are adequately validated and maintained; Discuss how errors resulting from IRT systems impact study conduct, data quality, and data reliability.
Speaker(s)
FDA Perspective
Phillip D. Kronstein, MD
FDA, United States
Team Leader, Division of Clinical Compliance Evaluation, OSI, CDER
MHRA Perspective
Stephen Vinter
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of Compliance