Ich-Gcp:Good Clinical Practice(Quiz+Guideline+Extra Lecture

Unlocking ICH-GCP E6 R2: A Complete Guide to Good Clinical Practice in Clinical Research

What you'll learn

In the ICH GCP (International Council for Harmonisation - Good Clinical Practice) course, students will learn the essential principles and guidelines

for conducting clinical trials ethically and ensuring the safety and well-being of human participants.

They will gain a comprehensive understanding of the regulatory requirements, documentation, and standard operating procedures involved in the entire clinical tr

The course will cover topics like trial design, informed consent, data collection, monitoring, adverse event reporting, and quality assurance.

By completing the course, students will be equipped with the knowledge and skills necessary to adhere to GCP standards

contribute to successful and compliant clinical research.

Requirements

Clinical Research Organizations staff, students

Beginners

Description

Embark on a transformative journey through our comprehensive online course, "Mastering ICH-GCP E6 R2: Good Clinical Practice for Clinical Research." This meticulously crafted program is your gateway to becoming a proficient and certified expert in the intricacies of conducting ethical and high-quality clinical trials.Designed for both novices and seasoned professionals, this course delves deep into the International Conference on Harmonization (ICH) guidelines, specifically E6 R2, elucidating every facet of Good Clinical Practice (GCP) in the realm of clinical research. With a dynamic blend of engaging multimedia content, interactive modules, and real-world case studies, you'll gain an in-depth understanding of the core principles of ICH-GCP E6 R2, ensuring the highest standards of participant safety, data integrity, and ethical conduct.Our industry-renowned instructors, each a luminary in their respective fields, will guide you through essential topics such as obtaining informed consent, protocol adherence, adverse event reporting, and investigator responsibilities. Additionally, you'll explore the critical role of Institutional Review Boards (IRBs) and gain practical insights into effective monitoring techniques.Upon successful completion, you'll not only be armed with a comprehensive knowledge of ICH-GCP E6 R2 but also earn a prestigious certification that solidifies your expertise and enhances your career prospects in the dynamic landscape of clinical research. Join us today and unlock the doors to excellence in Good Clinical Practice. Your journey toward mastering ICH-GCP E6 R2 starts here.

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Pharma Regulatory Jargons

Lecture 3 DMF

Lecture 4 Audit

Lecture 5 Regulatory Compliance and Requirements

Lecture 6 Regulatory Regime India, US and EU

Lecture 7 IPR, Copyrights and Patents

Lecture 8 IPR in India

Lecture 9 IRB or IEC

Section 2: ICH-GCP Principles, Importance, Link

Lecture 10 ICH GCP Preview

Lecture 11 ICH-GCP, Principles, Importance, Link

Section 3: ICH GCP E6 R2

Lecture 12 ICH GCP E6 R2 Guidelines

Lecture 13 Clause 2.1-2.13

Lecture 14 Investigator Clause 4.1-4.3

Lecture 15 Clause 4.4-4.7

Lecture 16 Clause 4.8-4.13

Lecture 17 Sponsor Clause 5.0-5.10

Lecture 18 Sponsor Clause 5.11-5.23

Section 4: Extra Lecture

Lecture 19 Quality Module 3.2 P.2

Clinical Research Organizations staff, students,Beginners