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Good Clinical Practice (GCP) Regulations and Guidelines

Regulations

Clinical Trials Directive 2001/20/EC

EU Commission Directive 2005/28/EC

EU Commission Directive 2003/94/EC

Declaration of Helsinki

 

UK Legislation

The Medicines for Human Use (Clinical Trials) Regulations 2004 - Statutory Instrument 1031

The Medicines for Human Use (Clinical Trials) Amendment  Regulations 2006 - Statutory Instrument 1928

The Medicines for human Use (Clinical Trials) Amendment (No.2) Regulations 2006 - Statutory Instrument 2984

The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 - Statutory Instrument 941

 

USA Regulations

 FDA Regulations relating to GCP and clinical trials


Guidelines

ICH E6 Guidelines for Good Clinical Practice

Medicines for Human Use - Eudralex

MHRA Serious Breaches Guidance

Clinical Trials Toolkit

 

QA Legislative Update

Click here to view the latest GCP Committee QA Legislative Update (July 2012)

 

MHRA Good Clinical Practice: The Inspection Process

Click here to view the process which covers types of inspection, routine inspection process flowchart, submissions, what to expect during ruotine inspections, findings and reporting of ruotine inspections and triggered inspections.

International Compilation of Human Research  Standards- 2013 Edition

US Department of Health and Human Services link to to laws, regulations, and guidelines that govern human subjects research in 104 countries, as well as the standards from a number of international and regional organisations. Click here.

The Global Guideline for GCP Audit

This guideline was completed based on global discussions among SQA, RQA and JSQA. The guideline includes the mission and the organisation of a sponsor's auditing department and establishes the principles for planning, performing and reporting audits. Click here for the latest version.

Regulations and Guidelines Archive 2009

Click here to view an archived regulations and guidelines document - while this information is not the most current, it may nonetheless be beneficial from a historical perspective.