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Regulatory Guidance on Outsourcing

The landmark guidelines for Good Clinical Practice globally were released by the ICH in 1996 – the now-famous ICH GCP E6. This was the culmination of a number of years’ work by the combined efforts of the regulatory agencies and industry associations of Europe, Japan, and the US, along with consideration of practices in Australia, Canada, the Nordic countries, and the WHO. The aim of the guideline was the harmonisation of regulatory requirements in what was then the regions of the world in which the majority of drug trials were conducted, namely Europe, the US, and Japan.

A review of the guideline reveals that a significant proportion of the document is taken up with describing the roles and responsibilities of various key players in the conduct of a drug trial. Entire sections are given over to the duties of an institutional review board (IRBs)/independent ethics committee (Section 3), an investigator (Section 4), the responsibilities of a sponsor (Section 5), and, within that, the activities associated with monitoring (5.18). The effects of this have been several-fold. The relationship between a sponsor and an investigator has been clearly established and a universal model for how ethics committees/IRBs should be set up and operate has been created. Additionally, the activities associated with monitoring have become the universal blueprint for the job description for a clinical research monitor/associate.

A lot has happened in the clinical research sector since the release of E6. The growth and widespread use of electronic data capture was one of the factors behind the release of EMA’s Reflection Paper on Risk Based Quality Management in Clinical Trials in 2013. Included in the glossary of this document is the definition of central monitoring, a concept that was not readily achievable in 1996 because of the reliance on predominantly paperbased data capture systems at the time. Also, in 2013 and in response to the advances in data capture, the FDA produced its Guidance for Industry, ‘Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring’. As with the EMA document, the subject of centralised monitoring is comprehensively covered, including a list of alternative monitoring techniques.

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Martin Robinson is Co-Founder and Executive Vice President at IAOCR. He has worked across the international biopharmaceuticals industry for nearly 30 years, and his extensive experience includes setting up a number of clinical research business ventures. Using his clinical operations and workforce development expertise, Martin is a leading expert in clinical research competence, at an individual and organisational level.
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