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Case Studies From FDA and MHRA: Good Clinical Practices
Session Chair(s)
Gail Francis
Expert Inspector, GCP
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
If you were not able to join in person on day two of the FDA-MHRA Good Clinical Practice Workshop, Data Integrity in Global Clinical Trials – Are We There Yet? last October, and missed the case study sessions, you will have a second chance in this Workshop. Attendees will work with regulators on two of the previously presented case studies to investigate data integrity and discuss the impact of their findings on overall study reliability.
Learning Objective : Evaluate how data management practices may impact data integrity and reliability; Discuss how data integrity is key to vendor selection; Describe and evaluate the impact of data blinding on data reliability; Evaluate how audit trails may be used to assess data integrity.
Speaker(s)
MHRA Perspective
Stephen Vinter
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Head of Compliance
FDA Perspective
Jean M. Mulinde, MD
FDA, United States
Associate Director, Division of Clinical Compliance Evaluation, OSI