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) 19 March 2015

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

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

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

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

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

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

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

  9. 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: March 2018

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

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

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

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

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

  15. 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: 19 March 2015

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

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

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

  19. World Health Organization (WHO) (2011) Guidelines on good manufacturing practices for blood establishments (GMP)

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

  21. World Health Organization (WHO) (2009) Handbook for Good Laboratory Practice (GLP) 2nd Edition

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

  23. World Health Organization (WHO) (2020) Laboratory Biosafety Manual (4th edition)

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

 

Other Resources:

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

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

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

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

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

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

  7. 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: 19 March 2015

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

  9. Westgard et al (2016), Basic QC Practices, 4th Edition: 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