ICH GCP E6(R2) and Risk-Based Approach to Monitoring | XTalks Webinar

ICH GCP E6(R2) Guidelines – how to put in place a risk-based monitoring approach; create an independent assessment of the integrity of data coming in from sites; reduce patient risk; and reduce monitoring costs (applicable to Sponsors only)

Monday, October 30, 2017
12:00 EST / 18:00 CET

Webinar organized by XTalks

XTalks ICH GCP E6 R2 risk based monitoring

Webinar Overview:

The ICH GCP E6(R2) addendum represents the biggest change in GCP guidelines in over 20 years and they are in effect as of June 2017. The FDA guidance for industry and the EMA reflection paper encourage greater reliance on centralized monitoring practices. 100% SDV is not required or expected by the FDA. Additionally it is limited in its ability to provide insight to data trends across time, patients and clinical sites.  The guidelines highlight that you can use a more comprehensive statistical approach to interrogate data. They also state that the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.

Webinar Objectives

In this webinar, data-driven CRO, CROS NT, will explain:

  • how Sponsors can conduct independent verification of the quality and integrity of the data collected from sites
  • how to further minimize risk for patients
  • how to optimize costs through more efficient monitoring
  • how to detect trial misconduct
  • how to meet regulatory requirements and follow guidelines related to taking a risk-based approach and interrogation of data

The webinar will provid a case study and focus on three key areas:

  • Risk Management Metrics
  • Centralized Statistical Intelligence
  • Data Visualization and Analytics