Good Clinical Practice (Gcp) And Clinical Trials

Master the fundamentals of clinical trials, ethics, ICH-GCP, regulatory roles, and modern innovations

What you'll learn

Understand the structure and purpose of clinical trials

Apply the core principles of ICH-GCP (E6 R2)

Identify the roles of key stakeholders: sponsor, investigator, CRA, CRC, and IRB

Navigate ethical guidelines and major regulatory bodies (FDA, EMA, ICH)

Interpret protocol elements, informed consent, and clinical trial oversight procedures

Distinguish between clinical trial phases, study designs, endpoints, and blinding

Learn how AI, decentralized clinical trials, and patient-centric approaches are reshaping research

Requirements

No prior experience required. Just curiosity and commitment to learning about clinical trials.

Description

Course DescriptionAre you looking to break into clinical research or strengthen your knowledge of Good Clinical Practice (GCP)? This comprehensive course is your complete roadmap to understanding how modern clinical trials are conducted—ethically, efficiently, and in full regulatory compliance.You’ll start with the foundations of clinical research, then dive into key historical milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report, which laid the groundwork for today’s ethical standards. From there, we’ll explore the ICH-GCP guidelines, the structure and roles in trial operations, and the lifecycle of a clinical study—from protocol to final report.We’ll also look forward: you'll discover emerging innovations such as decentralized trials (DCTs), AI applications, and patient-centered trial designs, helping you stay ahead in a rapidly evolving field.The course is structured into short, focused lectures—each with clear objectives and practical examples. Whether you're a student, healthcare professional, or aspiring CRC or CRA, this course will give you the solid foundation you need to succeed.Who This Course Is ForAspiring clinical research professionals (CRC, CRA, QA, Regulatory)Healthcare workers transitioning into researchMedical, nursing, pharmacy, and life science studentsSponsors, monitors, site staff, and ethics committee membersAnyone preparing for GCP or ICH certification or onboarding into clinical trialsRequirementsNo prior experience requiredJust curiosity and commitment to learning about clinical trials

Overview

Section 1: Introduction to Clinical Research

Lecture 1 What is Clinical Research?

Lecture 2 Phases of Clinical Trials

Lecture 3 Key Stakeholders in Clinical Research

Lecture 4 Overview of Regulatory Bodies (FDA, EMA, ICH, etc.)

Section 2: History and Evolution of GCP

Lecture 5 Nuremberg Code

Lecture 6 Declaration of Helsinki

Lecture 7 Belmont Report

Lecture 8 Development of ICH-GCP Guidelines

Section 3: Principles of Good Clinical Practice (GCP)

Lecture 9 Core Principles (ICH-GCP E6)

Lecture 10 Ethics and Human Subject Protection

Lecture 11 Informed Consent Process

Section 4: Regulatory and Ethical Frameworks

Lecture 12 Institutional Review Boards (IRBs) / Ethics Committees (ECs)

Lecture 13 Regulatory Submissions and Approvals

Lecture 14 Legal and Ethical Responsibilities

Section 5: Clinical Trial Design

Lecture 15 Types of Study Designs (e.g., RCTs, Cohort, Case-Control)

Lecture 16 Endpoints, Randomization, and Blinding

Lecture 17 Protocol Development

Section 6: Roles and Responsibilities

Lecture 18 Sponsor

Lecture 19 Investigator

Lecture 20 Clinical Research Coordinator

Lecture 21 Monitor (CRA)

Section 7: Clinical Trial Implementation

Lecture 22 Site Selection and Initiation

Lecture 23 Subject Recruitment and Retention

Lecture 24 Data Collection and Case Report Forms (CRFs)

Section 8: Safety Reporting and Monitoring

Lecture 25 Adverse Events (AEs) vs. Serious Adverse Events (SAEs)

Lecture 26 Data Safety Monitoring Boards (DSMBs)

Lecture 27 Risk Management Plans

Section 9: Quality Assurance and Auditing

Lecture 28 Monitoring Visits and Types

Lecture 29 Audits vs. Inspections

Lecture 30 Corrective and Preventive Actions (CAPA)

Section 10: Data Management and Statistical Considerations

Lecture 31 Data Integrity and Confidentiality

Lecture 32 Electronic Data Capture (EDC)

Lecture 33 Statistical Analysis Plan (SAP)

Section 11: Clinical Trial Closeout

Lecture 34 Study Completion and Reporting

Lecture 35 Final Study Report

Lecture 36 Archiving of Study Documents

Section 12: Future Trends and Innovations

Lecture 37 Decentralized Clinical Trials (DCTs)

Lecture 38 Use of AI and Digital Health in Trials

Lecture 39 Patient-Centric Approaches

Lecture 40 Recap of Key Takeaways

Clinical research professionals,Quality assurance professionals,Regulatory affairs professionals,Healthcare workers,Medical, nursing, pharmacy, and life science students,Anyone preparing for GCP or ICH certification,Anyone onboarding into clinical trials