Course References:

  1. British Association of Research Quality Assurance (BARQA) (2003) Good Clinical Laboratory Practice Version 1 (available as World Health Organization (2009) Good Clinical Laboratory Practice) Web 19 March 2015

  2. Centers for Disease Control and Prevention (CDC) (2009) Biosafety in Microbiological and Biomedical Laboratories (5th Edition): Web 22 March 2019

  3. Division of AIDS (DAIDS) (2013) DAIDS Guidelines for Good Clinical Laboratory Practice Standards: Web 9 July 2013

  4. European Medicines Agency (EMA) Good Laboratory Practice Compliance: Web 19 March 2015

  5. Global Health Technologies Coalition, 'Database for Regulatory Requirements': Web 19 March 2015

  6. International Air Transport Association (IATA) (2019) Dangerous Goods Regulations (DGR): Web 19 March 2019

  7. International Council for Harmonisation (2016) Harmonised Guideline, Integrated Addendum for Good Clinical Practice E6 (R2): Web 9 November 2016

  8. International Conference  on Harmonisation (2000) Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7): Web 29 May 2015

  9. International Conference on Harmonisation (2005) Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2 (R1): Web November 2005

  10. International Organization for Standardization (ISO): ISO/IEC 17025:2017 (BS EN ISO/IEC 17025:2017) - General Requirements for the Competence of Testing and Calibration Laboratories: Web March 2018

  11. International Organization for Standardization (ISO): ISO 15189:2012 (BS EN ISO 15189:2012) - Medical Laboratories - Requirements for Quality and Competence: Web 30 May 2015

  12. Office for Human Research Protections (2019) International Compilation of Human Research Standards: Web 22 March 2019

  13. Organisation for Economic Co-operation and Development (OECD) (1998) Principles of Good Laboratory Practice and Compliance Monitoring: Web 19 March 2015

  14. Organisation for Economic Co-operation and Development (OECD) (2016) Principles of Good Laboratory Practice and Compliance Monitoring Number 17: Web 22 April 2016

  15. Research Quality Association (RQA) (2012) Good Clinical Laboratory Practice (GCLP) Version 2: Web 19 March 2015

  16. Sarzotti-Kelsoe, M et al (2009) Evaluation and Recommendations on Good Clinical Laboratory Practice Guidelines for Phase I-III Clinical Trials. PLoS Med DOI: 10/journal.pmed.1000067: Web 19 March 2015

  17. The CRA Training Institute: Countries that follow ICH-GCP Guidelines for Clinical Trials: Web 19 March 2015

  18. US Food and Drug Administration (FDA) (2014) Good Laboratory Practice for Non Clinical Laboratory Studies:Web 19 March 2015

  19. Westgard, J. (2008) Basic Method Validation 3rd Edition: Web 30 May 2015

  20. World Health Organization (WHO) (2003) Guidelines on good manufacturing practices for blood establishments (GMP): Web 30 May 2015

  21. World Health Organization (WHO) (2017) Guidance on regulations for the Transport of Infections Substances 2017-2018: Web 22 March 2019

  22. World Health Organization (WHO) (2009) Handbook for Good Laboratory Practice (GLP) 2nd Edition: Web 19 March 2015

  23. World Health Organization (WHO) (2005) Handbook for Good Clinical Research Practice (GCP): Web 22 March 2019

  24. World Health Organization (WHO) (2004) Laboratory Biosafety Manual (3rd edition): Web 8 February 2017

  25. World Health Organisation (WHO) (2012) Tuberculosis Laboratory Biosafety Manual: Web 8 February 2017

 

Other Resources:

  1. Cancer Research UK Manchester Institute (2015) Challenges of the GCLP Environment: Web 29 May 2015

  2. European Commission for Health and Consumers Directorate General (2013) The Rules Governing Medicinal Prodycst in the European Union (vol. 10) Guidance Documents applying to Clinical Trials: Web 29 May 2015

  3. European Commission for Public Health (2001) Clinical Trials Directive 2001/20/EC: Web. 29 May 2015

  4. European Commission for Public Health (2014) Clinical Trials – Regulations EU No 536/2014: Web. 29 May 2015

  5. European Medicines Agency, Science Medicines Health. Good Clinical Practice Compliance: Web. 29 May 2015

  6. Medicines and Healthcare Products Regulatory Agency (MHRA) (2014) Good Clinical Practice for Clinical Trials: Web 29 May 2015

  7. Medicines and Healthcare Products Regulatory Agency (MHRA) (2014) Good Clinical Practice: Guidance and Inspections: Web 19 March 2015

  8. Pharmacelsus Contract Research Organisation. GCLP: Web 19 March 2015

  9. Todd C et al (2014): Implementation of Good Clinical Laboratory Practice within the External Quality Assurance Program Oversight Laboratory (EQAPOL): Journal of Immunological Methods Vol 409 pp91-98: Web 19 March 2015

  10. University of Liverpool Institute of Translational Medicine. Liverpool GCLP Facility: Good Clinical Laboratory Practice: Web 19 March 2015

  11. Westgard et al (2010), Basic QC Practices, 3rd Edition: Web 30 May 2015

 

Donated Materials:

  1. International Partnership for Microbicides (IPM) – ‘Good Clinical Laboratory Practice (GCLP) – Introduction to GCLP’ – Training materials

  2. Ken Awondo – Kenya Medical Research Institute (KEMRI) / Wellcome Trust Research Programme - GCLP training materials

  3. Pharmaceutical Product Development, LLC (2012) – GCLP traning materials

  4. Simon N Buhalata – ‘Minimum Requirements for Good Clinical Laboratory Practice – Good Clinical Laboratory Practices in Developing Settings’ – NIMR- Mwanza 13th June 2012