If an inspector walked in today and asked how you, the sponsor, have ensured that all the activities being performed during a Clinical Trial comply with the required regulations, could you easily answer that question? This course will review the steps to ensure oversight (in compliance with ICH E6(R2) and EU Clinical Trial Regulation 536/2014 and how to document and communicate the oversight activities so that everyone involved in the clinical trial can easily answer that question.
Sponsor Oversight is becoming more and more important: it isn’t just documenting that things have been done according to GCP: it is proactively setting up all clinical trial activities in such a way as to be confident that the safety and welfare of the subjects, the conduct of the study, and the data produced are at the expected levels of quality.
Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been granted PharmaTrain Recognition
This training session is organised as a classroom OR as multiple webinar sessions
1-Day face-to-face: 09:00 - 17:00
2 webinar sessions of 3 hours
Course long description
Oversight of Clinical Trials by the Sponsor is a critical component to ensure patient safety and data integrity and is now a major component of the Clinical Trial Regulations. But while the Regulations explain what oversight is, they do not explain how to do it. In this highly interactive course, the trainer will lead you through the many ways to focus your oversight and ensure human subject protection and high-quality data by focusing on the most important aspects of the conduct of the study.This course will provide you with best practice solutions for applying ICH E6 (R2) GCP & EU Clinical Trial Regulation 536/2014 on oversight in a pragmatic way to ensure oversight of all trial-related duties and functions carried out on behalf of the Sponsor. During this course you will receive a good understanding about the regulations guiding Sponsor Oversight as well as practical examples you can apply to your clinical trial (regardless of the size or type of Sponsorship) to ensure appropriate levels of clinical trial oversight, vendor, and sub-vendor oversight, including oversight of staff qualification, computerised systems, and risk management activities.This course will provide you with the different lens to look through to provide oversight to the many areas of clinical trials, such as patient safety, data integrity, budget management, resource management, and overall study conduct and reporting. By attending this course, you will understand the importance of Oversight across the study phases, including some special considerations for GLP Oversight, Roles & Responsibilities for Oversight when outsourcing, Oversight of Computerized Systems, Oversight of Staff Qualifications, as well as how to identify the most important data, KPIs and information for analysis by the sponsor to keep and maintain oversight of a clinical trial. The course will share real life case studies showing the importance of proper sponsor oversight and examples of good oversight and examples of improper oversight that could lead to critical or major audit findings. We will use interactive workshops so you can find the ideal solutions to apply under your clinical trial-related duties. You will be able to test your comprehension with a final grading assessment, and you will also walk away with specific solution-focused activities to enhance your sponsor oversight.
Understanding how Sponsor Oversight is the MAIN component for ensuring quality
Overview of the Regulations surrounding Oversight
Tools, methodologies, and preparation for Oversight activities
Practical solutions on how to fit “Oversight” into your current study plans
Understand the new elements of ICH-GCP that focus on Sponsor Oversight (E6 (R2/R3), E8 (R1) & E9(R1))
Identify your study’s most important data and critical to quality success factors to get to the right level of oversight for your staff, your CRO and other vendors and sub-contractors
Learn to perform robust Vendor Oversight through a combination of Co-monitoring Visits, tracking & reporting review (KPIs) and even budget review to identify issues that may be hidden or difficult to detect
Gain insight on the many ways to provide a well-rounded Oversight strategy based on the processes and systems available: CRO oversight, Team oversight, Co-Monitoring, Risk Management, Data review, Qualification & Auditing and Issue Escalation.
Who should attend
Clinical development personnel at the Sponsor who areinvolved in managing any aspect of a clinical trial that focuses on ensuring the protection of Subjects right, safety and welfare as well as ensuring the data collected are credible.
This includes Clinical Trial Managers, Project Managers, Senior CRAs, Data Managers, and QA Auditors. It is especially important for personnel who are involved with outsourced activities.
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