Good Clinical Practice in Clinical Trials (ICH-GCP)

Description

Course Overview

Good Clinical Practice (GCP) refers to a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human participants. These guidelines aim to ensure the safety, integrity, and reliability of data collected during clinical research while protecting the rights, safety, and well-being of trial participants.

The Good Clinical Practice in Clinical Trials (ICH-GCP) course covers key concepts and principles along with practical competencies essential for the successful conduct of clinical trials according to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Participants will gain a thorough understanding of the regulatory framework governing clinical research, including the roles and responsibilities of investigators, sponsors, and regulatory authorities.

Key Learning Objectives

• Understand the principles and objectives of Good Clinical Practice (GCP) guidelines as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
• Familiarize yourself with the regulatory framework governing clinical trials and the roles and responsibilities of key stakeholders, including investigators, sponsors, and regulatory authorities.
• Learn how to conduct clinical trials in compliance with ethical principles and regulatory requirements, ensuring the safety, rights, and well-being of trial participants.
• Gain knowledge of the informed consent process, including the requirements for obtaining and documenting informed consent from trial participants.
• Understand the importance of protocol adherence and the procedures for handling protocol deviations, adverse events, and serious adverse events during clinical trials.
• Learn about the principles of data management, including data collection, handling, and storage, as well as the importance of data integrity and quality assurance.
• Familiarise with safety reporting requirements and pharmacovigilance principles for monitoring and managing adverse events during clinical trials.
• Learn about the documentation requirements for clinical trials, archiving and retention of study records.
• Gain practical insights and best practices for ensuring compliance with GCP guidelines and regulatory requirements throughout the lifecycle of a clinical trial, from study initiation to closeout.

Course Structure

The course is delivered through a combination of online lectures, instructor-led case studies, live group discussions, and interactive activities, spanning approximately 60 hours.

The lectures, exams, and supplementary materials are structured to be finished at your own pace. The practical masterclasses are conducted in real-time and have set schedules. For the most up-to-date information regarding masterclass schedules for this course, please reach out to us directly at info@clueoclinical.com. You’ll have up to 6 months from the onboarding date to finish all aspects of the course.