Compliant guidelines important to a Company's plan to launch new drug, device or diagnostic, Research and Markets

Main Category: Pharma Industry / Biotech Industry
Article Date: 06 Jun 2005 - 0:00 PDT

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Research and Markets has announced the addition of A Guide to Good Clinical Practice to their offering.

This Guide contains the most recent versions of the regulations issued by the USA, Canada, the European Union, Japan, and the Consolidated Guidelines of the International Conference of Harmonization. Lack of compliance with GCP in sponsoring or performing clinical studies will result in regulatory sanctions and refusal of approvals, which will adversely affect a company's plans to launch a new drug product, device, or diagnostic. Regulations state that it is the responsibility of the company, as sponsor, to ensure that investigators and CROs follow the protocols and comply with GCP in all aspects of trial conduct. The commercial implications are thus the expenditure of significant sums of money on studies, which, even if they appear to demonstrate the safety and efficacy of the new product, will not lead to marketing approval if GCP compliance is not confirmed.

For the individual investigator and the institution in which he or she is working, the implications of GCP non-compliance may be loss of recognition by regulatory authorities as being acceptable as an investigator for future studies. Clinical studies are "big business" and non-compliance with the rules of Good Clinical Practice can be debilitating for business.

This Guide to GCP examines in detail the duties of sponsors, institutional review boards (IRB), investigators, and trial monitors. Practical advice is given on the means of achieving GCP compliance throughout the study. The templates of forms for study audits, data integrity checks, and for checking the IRB operations are included for the reader to use. The problems posed by the use of computers for trial data accrual and manipulation and compliance with 21CFR11 are given special attention. The Guide can provide assistance to corporate clinical departments considering new trials, personnel detailed to perform trial monitoring and auditing duties, members of institutional boards and clinical investigators and their supporting staff.

The contents of this report are as follows:

1 Executive Summary
2 Introduction
3 International Regulations Governing Good Clinical Practice
4 The Elements of GCP Compliance
5 The Sponsor - Duties and Responsibilities
6 The Clinical Investigator - Duties and Responsibilities
7 The Institutional Review Board/Ethics Committee (IRB/IEC)
8 The Investigator's Brochure
9 The Clinical Trial Protocol
10 Essential Documents for Trial Conduct
11 Internal and External Monitoring and Inspections
12 Checklists and Forms for Monitoring & Audits
13 References and Further Reading
14 Text of Regulations and Guidelines

For more information visit

researchandmarkets.com/reports/c18650

Laura Wood
Senior Manager
Research and Markets
press@researchandmarkets.com
Fax: +353 1 4100 980

Research and Markets
researchandmarkets.com/reports/c18650

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