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Transcript

1. GCP OVERVIEW

1. GCP Overview

The International Conference on Harmonisation guidelines define Good Clinical Practice as :

A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that:

  • the data and reported results are credible and accurate,
  • and that the rights, integrity, and confidentiality of trial subjects are protected.

INTRODUCTION

1. GCP Overview

The objective of this ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO).

INTRODUCTION

parties involved in a clinical study

Sponsor

IRB/IEC

Investigator

Competent Authority

Click on the title of the parties for more information

1. GCP Overview

Click here after the 'Competent Authority' slide

Sponsor

An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

# CSP - Article L1121-1
Le promoteur ou son représentant légal est établi dans l'Union européenne.

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Definition:

Implementing a system
to manage quality

Designing the protocol

Selecting Investigators

Financing the study

Notifying/
Submitting to Regulatory Authorities

Supplying and Handling Investigational Product(s)

Monitoring and Auditing

investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Subinvestigator

Investigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Definitions

The responsibilities of the investigator will be fully presented later in the presentation.

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investigator

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Subinvestigator

Investigator

Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Definitions

The responsibilities of the investigator will be fully presented later in the presentation.

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IRB/IEC

Institutional Review Board (IRB):

An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Independent Ethics Committee (IEC):

Definitions:

Next

Institutional Review Board (IRB):

Entities charged with protecting the rights and safety of clinical trial participants

Independent Ethics Committee (IEC):

In the United States, Institutional Review Boards have oversight and must abide by the United States Food and Drug Administration (FDA) regulations.

IEC is a more generic term for any ethical committee that review research

Clinical trials conducted in the European Union are held accountable by Independent Ethics Committees (IECs).

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Competent Authority

Bodies having the power to regulate. In the ICH GCP Guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections.

Definition:

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Thanks!

Let’s move to the next module: ‘The principles of ICH-GCP’

CTquality@gustaveroussy.fr