An Introduction to Good Clinical Practices (cGCP) – Part 1


Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonisation (ICH) for the design, conduct, performance, monitoring, auditing, recording, analyzes and reporting of clinical trials that involve the participation of human subjects. This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol preparation, patient monitoring, quality assurance, ethical / legal issues and much more.

Curriculum for this course:
Overview 1 min 10 secs
Learning Objectives 54 secs
Who Should Take This Course? 1 min 04 secs
Course Modules 1 min 30 secs
Module 1: Overview
What is GCP? 1 min 10 secs
History of Ethical Guidelines 1 min 05 secs
The Nuremberg Code 45 secs
Declaration of Helsinki 50 secs
The Belmont Report 1 min 20 secs
International Guidelines for Biomedical Research Involving Human Subjects 1 min 07 secs
The Principles of ICH-GCP – Part 1 1 min 34 secs
The Principles of ICH-GCP – Part 2 1 min 42 secs
Knowledge Check 1 min
Module 2: Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
What is the IRB/IEC 1 min 20 secs
Composition of the IRB/IEC 1 min 10 secs
Major Responsibilities of the IRB/IEC 1 min 32 secs
Working Procedures 1 min 17 secs
Maintenance of Records 1 min 46 secs
Knowledge Check 1 min
Module 3: An Overview of Investigators Responsibilities
Who Can Be an Investigator? 1 min 07 secs
Responsibilities: Resourcing 1 min 18 secs
Responsibilities: Medical Care of Trial Subjects 1 min 29 secs
Responsibilities: Ethical Approval 1 min 36 secs
Responsibilities: Compliance with Protocol 1 min 42 secs
Responsibilities: Investigational Medicinal Products (IMP) 58 secs
Responsibilities: Randomization 1 min 50 secs
Responsibilities: Records and Reports 51 secs
Responsibilities: Safety Reporting 1 min 25 secs
Responsibilities: General Responsibilities 1 min 31 secs
Knowledge Check 1 min
Module 4: Informed Consent
Informed Consent and its Importance 1 min 21 secs
Informed Consent Process 1 min 35 secs
Informed Consent Form 1 min 17 secs
Revisions to Informed Consent 1 min 52 secs
Knowledge Check 1 min
Final Assessment

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