09/13/2022
Clinical Pathways’ Sam Sather is proud to present a Masterclass on the recently updated guideline ICH E8(R1), General Considerations for Clinical Studies, with the event hosted by Global Leadership Conferences.
Date: November 3 & 4, 2022
Sign up HERE.
Clinical trial design and conduct have become more complex, impacting the time and cost required to develop drugs. ICH E8(R1) is intended to address the concerns about the principles of trial design and planning that are needed to ensure an appropriate level of data quality. The revision incorporates current concepts, including fit-for-purpose data quality, as one of the essential considerations for all clinical trials. It expands the idea of a proportionate approach to trial design and conduct and the process of focusing on the items that are critical to the quality of the trial - the protection of participants and the reliability of the data - to ensure that the results are quality enough to support good decision making. The focus is not on the perfection of results but the assurance of quality.
ICH E8(R1) maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.
Need live training for your teams on a different schedule? Contact us at info@clinicalpathwaysresearch.com.
No time for a Masterclass? We offer small team trainings and eLearning for individuals or teams!
This interactive eLearning course covers the importance of ICH and why a revision to E8 was needed, overarching themes of changes, the introduction of Quality by Design and Critical to Quality applied to clinical trials, an overview of the sections of the Guideline, and scenarios.
The course is available for purchase HERE.
Learning Objectives
1. Recognize how ICH E8(R1), the Guideline for General Considerations for Clinical Studies, has changed organizational processes.
2. Apply the Guideline to key concepts in clinical trials.
3. Discuss implementation challenges and opportunities regarding the updates in the Guideline.
Audience
A foundation training applicable for all clinical research professionals involved with the design, planning, and conduct of clinical trials.
Customization Available
A fully customized course can be developed for training teams, or for live in person or online workshops. Full LMS compatibility with SCORM packages available. Contact us at info@clinicalpathwaysresearch.com for additional information or to arrange a meeting to discuss.
Enterprise Pricing Available
Off the shelf pricing for over 10 licenses from the store is available when you contact us at info@clinicalpathwaysresearch.com.
Want training for longer than the license timeframe but do not have an LMS? Clinical Pathways can host annual training in our LMS to support your learners, with reports and certificates of completion for audit readiness.
- The Clinical Pathways Team
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