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Quality in Research

Guidelines for working in non-regulated research


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Since the first publication of the Guidelines for Quality in Non-Regulated Scientific Research in 2006, the discovery landscape has exploded. Innovation truly abounds in all fields. This phenomenal advance has burst open the door of personalised medicine and diagnostics, as well as fuelled ethical and regulatory debate regarding its better use. Our advance in scientific understanding and capability is simply extraordinary. But with rapid advance comes risk. And when those simple checks and balances have been overlooked and research data is not fit for purpose, then negative consequences can be seismic in proportion. Little wonder then that institutions both large and small are recognising the wisdom of mitigating risk by introducing 'Quality' into their culture.

The aim of this updated Guideline is to facilitate the stepwise and straightforward development of a value-adding Quality System into any research institute. We have, in this second edition tailored our approach to help make the case for implementation essentially a 'no brainer'. In each section, we now review the risks posed by poor systems of work and exemplify, with real life examples or case studies, the consequences of non-robust research process. The potential steps which can then be taken to overcome such issues are highlighted, drawing on the original Guidelines as a basis, and then we indicate the additional benefits that good process often brings.


1. Editorial

2. Use of the guideline

3. Project management

4. Personnel

5. Facilities

6. Equipment

7. Materials and reagents

8. Assay validation

9. Procedures

10. Research and work records

11. Computerised systems

12. Research review

13. Quality system

14. References

15. Acknowledgements


Louise Handy and Steve Volsen


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September 2014



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