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

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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.

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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. Pharmaceutical companies are increasingly open to exploring these types of relations. As this type of collaboration becomes more common, significant challenges exist on both sides in terms of managing expectations and achieving acceptable levels of compliance with regulatory requirements governing the use of e-clinical technologies, referred to herein as e-clinical systems. 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. The systems that are used range from single ‘simple’ programs for specific trials to multi­module, complex data management systems. Through the use of worked examples, this publication aims to help both research organisations and industry sponsors to understand how to successfully deploy e-clinical systems for use in clinical trials in a regulated environment. The authors reference the detailed guidance on computerised systems validation (CSV) provided in their earlier publication Computerised Systems Used in Clinical Research (2nd edition) to provide a consistent, risk-based approach for determining whether an e-clinical system is ready, or can be made ready, to adhere to international gold standards, national Jaws and/or regulations applicable to good clinical practice (GCP).