Introduction, History and Principles of ICH- GCP

in this module we will review what good clinical practice is the definition of GCP and what its purpose and objectives are most importantly we will focus on the 13 principles of GCP let's start with the definition the history and basics of GCP give a better understanding of what these standards are good clinical practice also known as I CH GCP or simply GCP is an international quality standard that is provided by the International Conference on harmonization or I CH which governments can transpose into regulations for clinical trials involving human subjects good clinical practice guidelines include protection of human rights as a subject in clinical trials it also provides assurance of the safety and efficacy of the newly developed compound good clinical practice guidelines include standards on how clinical trials should be conducted to find the roles and responsibilities in clinical trial sponsors clinical research investigators and monitors the first very important invent which contributed considerably for the introduction of good clinical practice standards was the Declaration of Helsinki the Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the world Medical Association or WME it is widely regarded as the cornerstone document of human research ethics the Declaration was originally adopted in June 1964 in Helsinki Finland and has since undergone six revisions the most recent at the General Assembly in October 2008 and two clarifications growing considerably in length from 11 to 35 paragraphs the declaration is an important document in the history of research ethics as the first significant effort of the medical community to regulate research itself and forms the basis of most subsequent documents maybe you have heard of the terms WH o GC p and IC h GC p let's take a closer look and see what the differences between WH o GC p and I see hg c PR the WH ol the World Health Organization started the process of developing guidelines in the late 1960s by the mid-1970s one of their scientific groups formulated proposals and guidelines for research in the field of drug development which eventually concluded with the WH o GC P guidelines being published in 1995 these reports also provided the basis for the IC h GC p as an international guideline published in 1996 so the WH GCP guidelines and IC h GC p we're more or less written in parallel by some of the same experts and are basically similar differences in content and style reflect differences in their intended purpose as the purpose of GCP is to ensure the correct conduct of clinical trials let's review what the thirteen principles of GCP are 1 clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and the applicable regulatory requirement - before a trial is initiated foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society a trial should be initiated and continued only if the anticipated benefits justify the risks 3 the rights safety and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society for the available non clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial 5 clinical trials should be scientifically sound and described in a clear detailed protocol 6 a trial should be conducted in compliance with the protocol that has received prior institutional review board or IRB independent Ethics Committee or IEC approval or favorable opinion 7 the medical care given to and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician or when appropriate of a qualified dentist eight each individual involved in conducting a trial should be qualified by education training and experience to perform his or her respective tasks nine freely given informed consent forms should be obtained from every subject prior to clinical trial participation 10 all clinical trial information should be recorded handled and stored in a way that allows its accurate reporting interpretation and verification 11 the confidentiality of records that could identify subjects should be protected respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements 12 investigational products should be manufactured handled and stored in accordance with applicable good manufacturing practice or GMP they should be used in accordance with the approved protocol 13 systems with procedures that assure the quality of every aspect of the trial should be implemented

Channel: Astra Nova Training

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Keywords: GCP, Histroy and Principles of ICH GCP, Good Clinical Practice, Quality Assurance, Clinical Trials, Clinical Management

Id: 056u-R8Uxc4

Length: 6min 36sec (396 seconds)

Published: Tue Mar 04 2014