This webinar highlights the critical role Data Managers will play in implementing the revised Good Clinical Practice Guidelines ICH E6(R2). Data Managers will be front and center in evaluating and designing new technology approaches to implement the requirements for Quality Management that are the cornerstone of CH E6(R2).
Transforming Risk Assessments into tools that will enable the near real-time review of critical study data, the data manager will play a key role in every aspect of ICH E6(R2). In addition to designing the systems, including data analytics and visualizations, data managers’ skills should include the ability to perform near real-time review at the subject level, across subjects at a site, and across sites.
• Data Managers will be able to perform a Risk Assessment for a protocol and determine how data systems will be affected.
• Data Managers will be able to determine how to monitor a particular risk and design data collection or reporting systems to monitor the particular risk identified.
• Data Managers will be able to describe how to implement data oversight approaches that will identify systematic data errors using central review approaches
• Data Managers will be able to describe how root cause analysis plays a critical role in Corrective Action Plans.
Dr. Manasco has held almost every job in the clinical research arena; Principal Investigator at the National Institutes of Health, Medical Monitor, Clinical Research Management, and Vice President of top 10 Pharmaceutical Compan. For the past 15 years, Dr. Manasco has worked as a technology executive (co-founded two companies), a consultant, and CRO CEO to design and implement data and document systems for the enhanced remote oversight of trials.
The MANA Method is a completely integrated technology-focused method for Quality Trial Management that can be licensed by Sponsors and CROs to enable efficient, rapid adoption of ICH E6(R2). It includes technology systems for data and document collection and review, data analytic tools, SOPs, Plan templates, and training materials for rapid, robust adoption.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
*Please note that a group should be constituted of max. 10 people who will be allowed to take the assessment questions after the webinar. Different members of one group will be able to log in from different regions of the world.