Objectives of Good Clinical Practice in Clinical Research

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PART ONE. OBJECTIVES OF GOOD CLINICAL PRACTICE IN CLINICAL RESEARCH

Worldwide acceptance of clinical data requires harmonization in the conduct of clinical trials. Clinical trials help to better understand diseases and their treatments and ensure an adequate evaluation of the safety and efficacy of new medicinal products or new indications of a marketed product before marketing authorization is granted.

Clinical research in general and drug development in particular are complex, scientific, regulatory-driven and long-term activities. In a clinical trial, the therapeutic intervention of interest may be a medicinal product, but can also be a medical device, or the combination of both, or any other clinical investigations that may have an impact on the safety and well-being of human subjects.

Drug development includes pharmaceutical development; new medicinal product formulation, preclinical activities (in laboratories and on animals) and clinical development (on humans) and requires several steps before marketing authorization is granted.

In this Good Clinical Practice training module, we focus on clinical research where administration of a medicinal product is the therapeutic intervention. The investigation may concern a newly discovered compound, often called new medicinal entity, or a recognized medicinal product for which a new indication or a new formulation is being developed. In all circumstances the therapeutic intervention is the administration of a so-called Investigational Medicinal Product.

Good Clinical Practice principles are recommended for all interventional clinical trials, including those with medical devices or other therapeutic interventions. Due to variations in rules and laws, this training module only focuses on "interventional clinical research of Investigational Medicinal Product".

PART TWO. PRECLINICAL ACTIVITIES

This section deals with pre-clinical activities to provide the course participants with an insight into the work that is required before the first administration of a new medicinal product in humans can take place. A full review of pre-clinical research requisite falls outside the scope of a basic Good Clinical Practice training program. Course participants who are interested in this particular topic are advised to look at the Investigator Brochure and/or consult qualified pre-clinical experts. The minimum information that should be included in an Investigator Brochure is delineated in ICH-Good Clinical Practice guidelines section seven.

Two point one. Introduction

Two point two. Preclinical toxicity studies

PART THREE. CLINICAL TRIALS

Three point two G C P in non-interventional clinical studies

Three point three Clinical Trial Principles

Three point four Clinical Trial Phases

Four point one Principles

Four point two Blinding

Four point three Randomization

Four point four Stratification

Four point five Sample Size

Four point six Type One and Two Errors

Four point six point two Type II error

Four point seven Power

Four point eight P value

PART Five. BASIC CLINICAL TRIAL METHODOLOGY: TRIAL DESIGNS

PART six. HISTORICAL BACKGROUND

RECENT ISSUES

Six point one. Historical Development of Reference Documents used in Clinical Trials

Nuremberg Code

Universal Declaration of Human Rights (United Nations)

Declaration of Helsinki (World Medical Association - W M A), regularly reviewed

Nineteen seventy-nine

Nineteen ninety-seven

Two thousand

Two thousand two

Two thousand eight

Six point one point two Laws and regulations related to GCP in clinical research

U.S. Food and Drug Administration twenty-one Code of Federal Regulations, Parts eleven, fifty, fifty-four, fifty-six, three hundred twelve, three hundred fourteen

Japanese GCP law

French Loi Huriet

Nineteen ninety-two

WHO - GCP guideline (the guideline was developed to be applied for registration clinical trials)

ICH-GCP E6 guideline (the guideline was developed to be applied for phase one through three pre-registration clinical trials)

Two thousand four

Six point two ICH Approach

ICH GUIDELINES

Six point two point one Good Clinical Practice: what is it?

Six point two point two Good Laboratory Practice: what is it?

Six point two point three Good Manufacturing Practice: what is it?

PART Seven. GCP in Clinical Trials

Seven point one Applicability of GCP

Seven point two GCP Principles

Seven point three GCP Summary

PART Eight. Research Ethics Committee, Independent Ethics Committee, Institutional Review Board

Eight point two Reminder

Eight point three Research Ethics Committee Record Keeping: Variations in Rules and Laws

Nine point one Be an Investigator

Nine point two Investigational Site Organization

Nine point three Pre-trial Processes

Nine point three point one REC Approval/Favorable Opinion Before the Trial Starts

Nine point three point two Finances

Nine point three point three Trial Participant

Nine point three point four Investigational Medicinal Product

Nine point three point five Investigator Site File:

Nine point four During the Trial

Nine point four point one Protocol deviations/changes

Nine point four point two Communication with the REC

Nine point four point three Informed Consent

Nine point four point four Investigational Medicinal Product

Nine point four point five Adverse Event and Serious Adverse Event

Nine point four point six Premature Discontinuation of the Trial

Nine point four point seven Investigator Site File during the Course of the Trial

Nine point four point eight Investigator during Trial Summary.

Nine point five Post-Trial Processes.

Nine point five point one Investigational Medicinal Product.

Nine point five point two Communication with the REC and Regulatory Authorities.

Nine point five point three Essential Documents and Archives.

Nine point five point three point two Records keeping: Variations in Rules and Laws.

Nine point five point four Investigator Summary.

Ten point one Sponsor Definition.

Ten point one point one Sponsor-Investigator: Variations in Rules and Regulations.

Ten point two. Be a Sponsor

Ten point three. Contract Research Organization

Overview

The document focuses on the principles of Good Clinical Practice in clinical research, detailing preclinical activities and the phases of clinical trials to ensure safety and efficacy before marketing authorization of medicinal products.

Key Points

1Good Clinical Practice ensures the safety and well-being of human subjects in clinical trials
2Preclinical activities are essential for assessing the safety of medicinal products before human testing
3Clinical trials are classified into phases to evaluate safety and efficacy systematically
4The Investigator Brochure must contain comprehensive information on preclinical and clinical data for regulatory compliance

Details

Category: Health and Medicine

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