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  • Computer Systems Validation in Clinical Research – A Practical Guide Edition 2

    The purpose of the 1st Edition of the Guideline was to suggest approaches by which validation might be achieved. The 2nd Edition updates these approaches in light of changes to the technology and regulatory landscape and provides additional guidance on the tools necessary to achieve validation, such as risk management and requirements analysis.  This Guideline is structured as an aid to both the novice and the experienced practitioner. It describes how to incorporate validation within the culture of an organisation via a high-level strategy, SOPs and clearly identified accountability.

  • Guidelines for Writing Standard Operating Procedures

    Standard Operating Procedures (SOPs) are guidelines which are instaIled by an organisation to ensure the consistent approach by those involved to that organisation’s activities. Within Clinical Data Management, such SOPs are an essential foundation for ensuring that current guidelines, e.g. Good Clinical Practice (GCP) are adhered to in producing reliable clinical data.

  • £14.00

    For data managers, laboratory data can prove to be a frustrating, if not bewildering, subject with unrivalled subtleties and pitfalls. This book sets out to document many of these problems and give the reader a better understanding of his/her data.

  • Validation and Management of e-Clinical Systems in Collaborative Clinical Trials

    Academic researchers are increasingly supporting their clinical research through the development of novel electronic technologies. These can take many forms such as tools, devices, systems, tests, methodologies and processes. Researchers sometimes engage with potential industry partners, either directly or through a commercial or semi-commercial organisation. To help meet these challenges, the authors of this document have applied their own experience to address frequent concerns and recurring risks related to the use of e-clinical systems in the context of academia – industry collaborations.