ICH GCP E6 (R2) Refresher Training Bundle
These seven sessions are intended to give participants a foundational understanding of the recent changes to ICH GCP E6 through the R2 addendum. You will gain a fundamental understanding of major changes to the guidance, plus major differences between the previous and current version. You will learn what’s new, what’s important, and how to update your efforts. This program will be beneficial to literally anyone working with clinical trials.
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum
The recent update to ICH GCP E6 (R2) emphasizes the use of “smarter” onsite, remote and centralized monitoring practices. Join our interactive live webinar to receive a practical guide to implementing an effective monitoring plan.
Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum
Investigator Oversight is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
ICH E6 Addendum R2 Team Training and Action Planning
The new revision of ICH E6 Guidelines (R2 Addendum) focuses on updating and clarifying standards for sponsor and investigator oversight, quality data characteristics, electronic records and essential documentation. Join our webinar to learn about the major updates to train your team and be ready to implement the guidelines.
Quality Risk Management Post ICH GCP E6 R2 Addendum
Quality Risk Management (QRM) is essential to running an effective, compliant clinical trial. New ICH GCP E6 (R2) guidelines suggest changes in how this should be done. Join us for this interactive session to learn more.
Monitoring Electronic Health Records (EHRs): Frequently Asked Questions – Understanding the Recent May 2016 FDA Draft Guidance
This course will provide attendees with clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR). Common confusion points about site requirements for source documentation and sponsor monitoring of electronic health records will be discussed in detail.
HIPAA & Source Data Access: Dispelling the Myths
This course will help you navigate confusing HIPAA requirements and provide solutions to ensure patient data security. Through instruction and value-added documentation, you will walk away with actionable knowledge to keep your efforts compliant, and have the ability to separate fact and fiction.
Writing Clinical Monitoring Reports: Using the Liquid Report Writing Method
This course presents design and writing techniques for “liquid report” planning and writing, using the report as a dynamic “living document” that harmonizes metrics, risk indicators, and action plans – and should be written by the time a monitor leaves the site or finishes the monitoring activity (e.g., remote monitoring).