Fundamentals of Clinical Research: GCP & Bioethics

About Course

A Good Clinical Practice (GCP) training course provides the foundational knowledge required to conduct clinical trials in an ethical and scientifically sound manner. It covers the international standards set by the International Council for Harmonisation (ICH) to ensure participant safety and data reliability.

Core Principles: Deep understanding of the 13 core principles of GCP, including ethical conduct, medical care for subjects, and scientific validity.
Roles & Responsibilities: Clearly defined obligations for investigators, sponsors, monitors, and Institutional Review Boards (IRBs).
Informed Consent: The detailed process of obtaining and documenting voluntary participant consent.
Regulatory Compliance: Navigating international and local laws, such as those from the US FDA and EMA.
Safety Reporting: Protocols for identifying and reporting adverse events and managing risk during a trial.
Data Integrity: Standards for recording, maintaining, and reporting trial data to ensure it is verifiable and transparent.
Trial Documentation: Proper management of essential documents like the Investigator Site File and Trial Master File.

Course Content

Pre-Training Assessment:

Pre-Training Assessment: Baseline Knowledge Check

Module 1: Good Clinical Practice Guidelines

Module 2: Overview of NDCT Rules, 2019 & Amendments

Module 3: Safety Management and Reporting Requirements

Module 4: A Comprehensive Overview of Clinical Trial Documentation

Module 5: Role & Responsibilities of Key Stakeholders (Investigator & Sponsor)

Module 6: Ethical Considerations in Clinical Research

Post-Training Assessment

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Fundamentals of Clinical Research: GCP & Bioethics

About Course

What Will You Learn?

Course Content

Pre-Training Assessment:

Pre-Training Assessment: Baseline Knowledge Check

Module 1: Good Clinical Practice Guidelines

Introduction to Good Clinical Practice (GCP)

Module 2: Overview of NDCT Rules, 2019 & Amendments

NDCT Rules 2019 & Amendments – Regulatory Framework

Module 3: Safety Management and Reporting Requirements

Safety Management & Adverse Event Reporting

Module 4: A Comprehensive Overview of Clinical Trial Documentation

Clinical Trial Documentation Essentials

Module 5: Role & Responsibilities of Key Stakeholders (Investigator & Sponsor)

Stakeholders in Clinical Trials – Investigator & Sponsor Roles

Module 6: Ethical Considerations in Clinical Research

Ethics in Clinical Research

Post-Training Assessment

Post-Training Assessment: Knowledge Evaluation

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