Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide

Date: January 18, 2017
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

Mandated approaches to monitoring clinical trials continue to go through great revisions. The recent update to ICH E6 (R2) has intensified the pursuit of improved monitoring practices that include access to the clinical trial activities sooner to better manage risk and decrease cost of travel/rework due to noncompliance. Simply adding remote oversight to a sponsor’s monitoring plan does not equal a risk-based approach or guarantee to improve anything, but is actually more likely to increase risks and damage stakeholder relationships. However, if done correctly, remote monitoring can support improved trial outcomes when matched with the right situation, the right remote approach, and the right implementation plan. This leaves the main question:  What is the best way to integrate remote monitoring?

Attend this interactive webinar to receive a practical guide to implementing remote monitoring, where we will break down the revisions to ICH GCP e6 (R2) and answer some of your most pressing questions.

By participating in this interactive live session and you will be able to: 

  • Identify various types of remote monitoring with and without technology system leverage and integration
  • Recognize the components of an assessment and implementation plan for remote monitoring for a specific trial
  • Discuss the role of the remote monitor, training needs, and oversight (more than the CRA?)
  • Understand what has changed, what hasn’t, and discover what will matter most with these recent changes

This course will be of benefit to anyone responsible for monitoring – or supervising the monitoring of – a clinical trial. This includes monitoring, safety, data management, quality departments within sponsor companies/CROs/Sites and IRBs.

Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC).  She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).