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