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  4. FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020: 02/13/2020 - 02/14/2020
  1. News & Events for Human Drugs

FDA and MHRA Good Clinical Practice Symposium: Data Integrity in Global Clinical Trials - Tackling Challenging Topics in 2020: 02/13/2020 - 02/14/2020

Date and Time:

  • Thursday, February 13, 2020 8:30 AM -5:30 PM GMT (livestream available on day one only)
  • Friday, February 14, 2020 8:00 AM – 2:00 PM GMT

Location:

  • Novotel London West Hotel- 1 Shortlands, Hammersmith, London. W6 8DR, UK

Registration:

See Good Clinical Practice Symposium 2020 to register for the event. Day one of the symposium will be available through a livestream.

Summary:

This event continues the discussion from the October 2018 GCP Symposium: Data Integrity in Global Clinical Trials - Are We There Yet? The 2020 symposium will provide regulatory perspectives on the importance of sponsor oversight of clinical sites and laboratories, eSource including electronic health records, protocol deviations including the impact on clinical trials and the challenges in ensuring data quality in novel clinical trial designs. On day two, workshop participants will have opportunities to work on relevant case studies on these topics.

Participants will learn:

  • Key aspects regarding sponsor oversight of clinical investigator sites and laboratories
  • Impact of eSource on clinical data
  • Investigator control of their data
  • Impact of data quality on decision making
  • How handling of protocol deviations impact data reliability and subject safety
  • The challenges faced in ensuring data quality in novel clinical trial design

 

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