Certificate Course In Ich-Gcp [Good Clinical Practice]

ICH-GCP, E6 (R2+R3), Good Clinical Practice, IRB/IEC, Investigator, Sponsor

What you'll learn

Fundamentals of ICH-GCP

Principles of ICH-GCP

Roles & Responsibilities of IRB/IEC

Roles & Responsibilities of Investigator

Roles & Responsibilities of Sponsor

Investigator's Brochure (IB)

Clinical Trial Protocol and its Amendment

Essential Records for the conduct of Clinical Trial

Requirements

Laptop / PC/ Cellphone

Good Internet connection

Basic English

Description

Title: Certificate Course in ICH-GCP [Good Clinical Practice]Master the Principles of Ethical Clinical Research.Are you looking to establish a strong foundation in clinical research ethics and compliance? Enroll in our comprehensive "Certificate Course in ICH-GCP [Good Clinical Practice]" to gain an in-depth understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines.Key Highlights:Essential ICH-GCP Principles: Dive into the core principles of ICH-GCP, including the protection of human subjects, data integrity, and the ethical conduct of clinical trials. Understand the requirements for conducting clinical research that is accepted globally.Roles and Responsibilities of IRB/IEC: Gain insights on Roles and Responsibilities of IRB/IEC, their Composition, Functions and Operations, Procedures, Records, Submission and Communication.Roles and Responsibilities of Investigator: Understand Roles and Responsibilities of an Investigator, Protocol compliance, Premature suspension of trial, Medical care, Safety Reporting, Informed consent & End of Participation, Investigational product management, Randomization & Unblinding.Roles and Responsibilities of Sponsor: Understand Roles and Responsibilities of a Sponsor, Communication with IRB/IEC and Sponsor oversight, Quality management, Non-compliance, safety assessment & reporting, Investigational products, Data/ Records and Clinical study report.Investigator's Brochure: Development of the Investigator’s Brochure, Reference Safety Information and Risk-Benefit Assessment, General considerations and Contents of the Investigator’s Brochure.Clinical Trial Protocol and its Amendment: Clinical trial protocol and Content of Clinical trial protocol.Essential Records for the conduct of Clinical Trial: Management of Essential Records, Essential Records for All Trials and Potential Essential Records.Why Choose This Course?Industry-Recognized Certification: Earn a certificate that is recognized by the industry, showcasing your expertise in ICH-GCP to potential employers and sponsors.Career Advancement: Enhance your career prospects in clinical research. Gain the knowledge and skills required to excel in roles related to clinical trial management, monitoring, and regulatory affairs.Global Opportunities: ICH-GCP is an internationally recognized standard. Equip yourself with skills that are in demand worldwide, opening doors to global career opportunities.Who Should Enroll:Clinical Research Associates (CRAs)Clinical Trial CoordinatorsInvestigatorsRegulatory Affairs ProfessionalsAnyone interested in Ethical clinical researchDon't miss this opportunity to gain a comprehensive understanding of ICH-GCP and enhance your career in clinical research. Enroll now and take the first step toward becoming a proficient clinical research professional!Note: No prior knowledge of clinical research is required. Basic understanding of medical terminology is recommended.

Overview

Section 1: Fundamentals of ICH-GCP

Lecture 1 Introduction, Objectives and Scope

Lecture 2 Principles of ICH-GCP

Section 2: Roles and Responsibilities of IRB/IEC

Lecture 3 Introduction, Roles & Responsibilities

Lecture 4 Composition, Function and Operations

Lecture 5 Procedures, Records, Submission & Communication

Section 3: Roles and Responsibilities of Investigator

Lecture 6 Qualifications, Training, Resources & Responsibilities

Lecture 7 Communication with IRB/IEC & Protocol compliance

Lecture 8 Trial termination/suspension; Participant care & Safety reporting

Lecture 9 Informed Consent of Trial participants

Lecture 10 Ending Clinical trial participation & Investigational product management

Lecture 11 Randomization, Unblinding and Records

Section 4: Roles and Responsibilities of Sponsor

Lecture 12 Introduction

Lecture 13 Communication with IRB/IEC and Regulatory Authority

Lecture 14 Sponsor oversight

Lecture 15 Quality management

Lecture 16 Non-compliance, Safety and Reporting

Lecture 17 Investigational products, Data/Records and Reports

Section 5: Investigator's Brochure (IB)

Lecture 18 Introduction, General considerations, and Content of IB

Section 6: Clinical Trial Protocol and its Amendment

Lecture 19 Introduction and Content of Clinical trial protocol

Section 7: Essential Records for the conduct of Clinical Trial

Lecture 20 Introduction and Management of Essential Records

Section 8: Congratulations

Lecture 21 What to do after this training

Clinical Research Associates (CRAs),Clinical Trial Coordinators,Investigators,Regulatory Affairs Professionals,Pharmacy, Medical and Life science students,Anyone interested in Ethical clinical research