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.


ICH GCP has been updated for the first time in over two decades.  Are you ready?

What were you doing in 1996?  If you were working in clinical trials, chances are you were using a lot of paper and communicating with land lines.  It was also the last time ICH GCP E6 was updated.  Like technology, the way we conduct clinical studies has changed significantly.  After 20 years, ICH has decided to update its guidelines on Good Clinical Practices (GCP) and clinical trials with the release of ICH GCP E6 (R2).  There are several important updates to be aware of.  However, it is critical to know what has changed, what hasn’t, and how these changes affect you.

This webinar package is offered both live and on-demand, or can be customized for delivery at your firm. With your purchase, you may view in live or recorded formats.  Each course comes with a certificate of completion for the primary registrant, complete with contact hours to submit for CEU credit.

Your registration entitles you to one log-in per course. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per package purchase.


[stm_course_lessons][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”ICH E6 Addendum R2 Team Training and Action Planning “]

Webinar, 60 minutes

The revision (R2 Addendum) of ICH GCP E6 Guidelines was in response to the increase in scale, complexity, and cost of clinical trials.  A foundational understanding of these topics is critical to running successful trials.  Therefore, it is important to train your team on the revisions and have an action plan to implement improvements with change control in mind.

This session will provide you and your colleagues training on the major updates and how they specifically impact clinical researchers. Within each section covered, the training includes use cases to support application of the new requirements and suggestions for action planning.[/stm_course_lesson][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum”]

Webinar, 60 minutes

This session will provide you and your colleagues training on the essentials of Corrective and Preventative Action plans (CAPA) and Root Cause Analysis (RCA) related to recent changes in ICH GCP E6 (R2).  This interactive session will provide you with an overview of what you need to do to prepare and successfully execute RCA investigations that will lead to appropriate interventions.  You will work through specific use cases for clinical trials to support the correct application of RCA.  The training also includes suggestions for action planning to support your CAPAs, and underscores that “practice is essential” for successful RCA and CAPA programs.[/stm_course_lesson][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”Quality Risk Management Post ICH GCP E6 R2 Addendum”]

Webinar, 60 minutes

The latest update to ICH E6 R2 expects Sponsors and Contract Research Organizations (CROs) to have systems in place to design, conduct, report and oversee their clinical trials with a risk-based approach. Risk-based Monitoring (RBM) or Quality Risk Management (QRM) must reach into every functional area to ensure compliance and successful outcomes. Does your team have the knowledge and training documentation on QRM concepts and perform new RBM practices?  If not, you aren’t alone. This session serves as foundational training that will fit with – and support – any QRM project, and support your team’s confidence to think and perform differently.[/stm_course_lesson][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”Investigator Oversight Plans: Essentials for Inspection Readiness Post ICH GCP E6 (R2) Addendum”]

Webinar, 60 minutes

The ICH E6 update expects that investigators will have procedures in place to establish a level of oversight that ensures human subject protection, data integrity, and investigational product control.  These updates are of monumental significance in that we now have a Good Clinical Practice (GCP) guideline setting a clear expectation: Sites must have processes in place to ensure adequate investigator oversight.

This 60 minute session will provide you and your colleagues with an understanding of the essentials of Investigator Oversight, and which components of a site quality system and clinical trial execution plan must be in place.[/stm_course_lesson][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum”]

Webinar, 60 minutes

This session presents the new and updated ICH GCP Guideline content that helps clarify documentation best practices, (e.g., ALCOA-C, Certified Copy, Validation of Computerized Systems). The concepts are presented with use cases to ensure you can apply the definitions to real life scenarios.

Additionally, we will discuss “gray areas” within ICH GCP E6 (R2) that are not clear and must be defined for each study so you have set expectations for the sponsor/CRO, monitor, and site regarding documentation requirements.[/stm_course_lesson][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”Monitoring Plan Development Post ICH GCP E6 (R2) Addendum”]

Webinar, 60 minutes

The recent update to ICH GCP E6 (R2) has intensified the pursuit of improved monitoring practices.  This includes “smarter” onsite, remote, and centralized monitoring activities.  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.   If done correctly, however, the right blend of onsite, remote, and centralized monitoring can support improved trial outcomes.  This session will teach you the right blend of monitoring styles to achieve maximum efficiency and compliance.[/stm_course_lesson][stm_course_lesson icon=”fa-icon-stm_icon_seo_monitoring” badge=”lecture” title=”CRO Oversight Post ICH GCP E6 (R2) Addendum “]

Webinar, 60 minutes

The ICH E6 GCP update expects that sponsors will provide adequate oversight of a Contract Research Organizations (CRO) when sponsor responsibilities have been transferred for the conduct of a clinical trial. The updated expectations come in response to many negative global audit findings related to a lack of vendor oversight.

Risk management practices are now expected to be incorporated into the selection and oversight of CROs and other vendors. Establishing effective communication plans for risk analysis and action plan responsibilities is of paramount importance in preventing problems and ensuring inspection readiness.  This interactive session will teach you how.[/stm_course_lesson][/stm_course_lessons]

Is this training bundle right for me?  Can you deliver a customized session for my team?  We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800, option #3 (9am – 5pm EST, M-F) for assistance.

Additional information


Live + Recorded, Recorded Only


Single Participant, 5 Participant Value Package, 10 Participant Value Package


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