The recent update to ICH GCP E6 (R2) has intensified the pursuit of improved monitoring practices that include access to the clinical trial activities sooner in an effort to better manage risk and decrease cost of travel/rework due to noncompliance. This encompasses “smarter” onsite, remote, and centralized monitoring practices. Simply adding centralized and / or 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, the right blend of onsite, remote, and centralized monitoring can support improved trial outcomes.
Attend this 90-minute interactive webinar to receive a practical guide to implementing an effective monitoring plan. You’ll find out what required documentation should be in your sponsor/CRO trial master file (TMF) and the most common risks related to Risk-based Monitoring (RBM) you’ll need to mitigate. You’ll also learn the essential skills and training that are needed for monitoring personnel involved in RBM.
By attending this interactive live session, you will be able to:
- Identify various types of monitoring (with and without technology integration) in the post ICH GCP E6 (R2) world
- Recognize the components of an assessment and implementation plan for a monitoring plan for a specific trial.
- Discuss the role of the onsite, remote, and centralized monitor; including training needs and oversight (more than the CRA?).
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