Mastering Good Clinical Practice A Comprehensive Training

GCP

What you'll learn

Core principles and international guidelines of Good Clinical Practice (ICH-GCP)

Ethical considerations and regulatory requirements in clinical research

Effective site management, monitoring, and auditing practices

Best practices for data integrity, documentation, and risk management

Compliance strategies to prevent common GCP violations

Requirements

This course is ideal for clinical research professionals, including investigators, study coordinators, monitors, regulatory affairs specialists, quality assurance professionals, auditors, and anyone involved in the design, conduct, monitoring, and reporting of clinical trials.

Description

The Mastering Good Clinical Practice (GCP) Training Course is designed to provide a comprehensive understanding of GCP principles, regulations, and ethical considerations in clinical research. This training ensures that professionals conducting clinical trials follow global regulatory standards, protect human subjects' rights and safety, and maintain data integrity in medical research.Through a structured learning approach, participants will gain expertise in clinical trial protocols, investigator responsibilities, regulatory requirements, and best practices in clinical research management. The course follows ICH-GCP (E6 R2) guidelines, FDA, EMA, and other international regulatory standards to ensure compliance in clinical trials.Who Should Take This Course?This course is ideal for:- Clinical Research Associates (CRAs) & Clinical Trial Managers- Investigators, Sub-Investigators & Study Coordinators- Regulatory Affairs & Quality Assurance Professionals- Pharmaceutical, Biotech & Medical Device Professionals- Ethics Committee & Institutional Review Board (IRB) Members- Anyone involved in clinical research and trial managementNo prior clinical research experience is required, making this course suitable for beginners and experienced professionals alike.What You’ll Learn- Understand the principles of Good Clinical Practice (GCP) & its importance in clinical research- Explore ICH-GCP, FDA, EMA, and global regulatory guidelines for clinical trials- Learn investigator and sponsor responsibilities in clinical studies- Understand informed consent, ethics, and patient protection in trials- Master clinical trial documentation, monitoring, and data integrity- Prepare for GCP audits, inspections, and regulatory complianceCourse FormatDelivery Mode: Online / In-Person / Self-PacedDuration: 1 Day (Flexible Learning Options Available)Training Materials: Course slides, regulatory guides

Overview

Section 1: Introduction

Lecture 1 Introduction

Section 2: Core principles and international guidelines of Good Clinical Practice (ICH-GCP)

Lecture 2 Core principles and international guidelines of Good Clinical Practice (ICH-GCP)

Section 3: Ethical considerations and regulatory requirements in clinical research

Lecture 3 Ethical considerations and regulatory requirements in clinical research

Section 4: Effective site management, monitoring, and auditing practices

Lecture 4 Effective site management, monitoring, and auditing practices.

Section 5: Best practices for data integrity, documentation, and risk management

Lecture 5 Best practices for data integrity, documentation, and risk management

Section 6: Compliance strategies to prevent common GCP violations

Lecture 6 Compliance strategies to prevent common GCP violations

This course is ideal for clinical research professionals, including investigators, study coordinators, monitors, regulatory affairs specialists, quality assurance professionals, auditors, and anyone involved in the design, conduct, monitoring, and reporting of clinical trials.