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): 30 May 2015

  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: 19 March 2015

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

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

  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