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Wednesday, June 26 • 10:30am - 11:30am
#338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-669-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Jean M. Mulinde, MD

Speaker

FDA Perspective
Phillip D. Kronstein, MD

MHRA Perspective
Stephen Vinter


Speakers
avatar for Phillip Kronstein

Phillip Kronstein

Team Leader, Division of Clinical Compliance Evaluation, OSI, CDER, FDA
Phillip Kronstein, M.D. is a Team Leader for the Good Clinical Practice (GCP) Assessment Branch in the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Policy Advisor, Division of Clinical Compliance Evaluation, OSI, FDA, United States
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →

Wednesday June 26, 2019 10:30am - 11:30am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: R-D Quality-Compliance, Session |   03: Data-Data Standards, Session