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.

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.

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.

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.

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.

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.

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.