Objective

1.1 The objective of this SOP is to set out the procedures and responsibilities for the investigation and management of cases of suspected fraud/misconduct occurring in clinical research.

1.2 An outline of the procedures adopted by the Association of the British Pharmaceutical Industry and the General Medical Council, following company notification, are also covered.

1.3 It should be remembered that whilst all fraud is misconduct, not all misconduct amounts to fraud, only specialist investigation can reach this conclusion.

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