NIHR CRN GCP Resource A compilation of links to useful on-line GCP quality tools and resources NIHR CRN Good Clinical Practice Reference Resource Acknowledgements This GCP Resource has been produced by Dr Stuart McCully of Compliance Healthcheck Consulting UK Ltd (www.chcuk.co.uk) on behalf on the National Institute of Health Research (NIHR) NIHR CRN Good Clinical Practice Reference Resource DISCLAIMER Although this GCP Resource contains information of a legal nature, it has been developed for information and education purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new standards are issued on a continuing basis, this GCP Resource is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to non-interventional studies. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with the applicable National Competent Authorities and/or Research Ethics Committees before starting research activities. Copyright Information UK Statutory Instruments and Acts: Crown Copyright material is reproduced with the permission of the Controller of HMSO and the Queen’s Printer for Scotland. This information is licensed under the terms of the Open Government Licence (link) European Regulations, Directives and Guidelines: European Community Copyright material is reproduced with the permission of the European Commission. Version 3, May 2011 © NIHR CRN 2010 - 2011 3 NIHR CRN Good Clinical Practice Reference Resource Foreword The following document contains links to GCP-related articles, references, documents and websites and is aimed to serve as a resource to help develop and further your knowledge about Good Clinical Practice (GCP). For further details, or to add anything to this document, please contact the CRN Workforce Development team: CRN Workforce Development Team National Institute for Health Research Clinical Research Network Coordinating Centre 71-75 Clarendon Road, Leeds LS2 9PH T: 0113 343 0406 F: 0113 343 2300 E: [email protected] W: http://www.crncc.nihr.ac.uk/TRAINING Version 3, May 2011 © NIHR CRN 2010 - 2011 4 NIHR CRN Good Clinical Practice Reference Resource Table of Contents Acknowledgements .......................................................................................................... 2 DISCLAIMER ..................................................................................................................... 3 Copyright Information ............................................................................................................ 3 Foreword ......................................................................................................................... 4 Document History .......................................................................................................... 14 Good Clinical Practice – Recent Changes ......................................................................... 15 Changes to Legislation .......................................................................................................... 15 Clinical Trials Directive (2001/20/EC) (Beyond 2012) ...................................................... 15 Mandatory Electronic SUSAR Reporting (Sept 2010) ....................................................... 15 Updated Pharmacovigilance Requirements (July 2012) .................................................. 16 Regulation of Pharmacists, Pharmacy Technicians & Pharmacy Premises (Feb 2010) ... 16 Advanced Therapy Medicinal Products (ATMPs) (Aug 2010) .......................................... 17 Medical Devices (March 2010) ......................................................................................... 19 Changes to Procedures ........................................................................................................ 19 MHRA GCP Inspection Process (Oct 2009) ....................................................................... 19 Procedure for Investigating Research Misconduct (July 2009) ........................................ 20 Clinical Research Guidance .................................................................................................. 21 Electronic Source Data (Aug 2010) ................................................................................... 21 Guideline on Missing Data in Confirmatory Clinical Trials (Jan 2011) ............................. 21 Adults Lacking Capacity to Consent (Oct 2010) ............................................................... 23 Time to Consent (Sept 2010) ............................................................................................ 24 Good Practice in Research and Consent to Research (April 2010) .................................. 24 Future Direction of Clinical Research ................................................................................... 25 Equity and Excellence: Liberating the NHS (July 2010) .................................................... 25 Academy of Medical Sciences Report (Jan 2011) ............................................................. 25 UK Governments Plan for Growth (March 2011) ............................................................. 26 The Role of the NIHR CRN in Clinical Research ................................................................. 31 The National Institute for Health Research (NIHR) .............................................................. 31 Version 3, May 2011 © NIHR CRN 2010 - 2011 5 NIHR CRN Good Clinical Practice Reference Resource The Clinical Research Network (CRN) .................................................................................. 32 The Clinical Research Network Coordinating Centre (CRN CC) ........................................... 32 Key Documents Outlining the Role of Clinical Research in the NHS .................................... 33 NIHR Quality Tools & Templates .......................................................................................... 37 Investigator Site File Contents ......................................................................................... 37 Document Tracking Log .................................................................................................... 37 Milestone Summary ......................................................................................................... 37 Study Specific Training Log ............................................................................................... 37 Telephone Summary Template ........................................................................................ 38 File Note Template ........................................................................................................... 38 Treatment Allocation Log ................................................................................................. 38 Appointment Checklist ..................................................................................................... 38 Study Supplies Issues Log ................................................................................................. 39 Study Patient Visit Schedule ............................................................................................. 39 GCP: The Standards and Why We Have Them ................................................................. 40 Definitions ............................................................................................................................ 40 Good Clinical Practice (GCP) ............................................................................................. 40 Historical Foundation: Why Do We Need These GCP Standards? ....................................... 40 GCP History: The Nazi ‘Medical’ Experiments .................................................................. 40 GCP History: The Tuskegee Syphilis Study ....................................................................... 41 GCP History: Thalidomide................................................................................................. 42 Current Situation: We Still Need These GCP Standards! ..................................................... 44 Man Dies in Government Cancer Drug Trial (Oct 2007) .................................................. 44 US Investigator’s Lack of Oversight has Tragic Results (2009) ......................................... 46 Recent Examples of GCP Inspection Findings and GCP Misconduct ................................ 47 Global Clinical Trial Guidelines ........................................................................................ 50 Nuremberg Code (1947)....................................................................................................... 50 UN Declarations of Human Rights ........................................................................................ 50 UN Declaration of Human Rights (1948) .......................................................................... 50 UN Declaration on Bioethics and Human Rights (2005) .................................................. 51 UN Declarations on Human Genetic Data and Human Rights (1997 & 2003) ................. 51 Version 3, May 2011 © NIHR CRN 2010 - 2011 6 NIHR CRN Good Clinical Practice Reference Resource Declaration of Helsinki (1996, 2000, 2008) .......................................................................... 51