See Table A1.

Table A1. Standard operating procedures: activities and responsibilities.



Detection of suspected

Anyone who handles clinical data


or has contact with investigators

Chairing of the initial assessment

Quality Assurance Manager

meeting following discussion of the


Table A1. (continued)

Activity original person detecting the fraud/ misconduct with their line manager The quarantining of data and adverse drug reactions The decision to withhold payments Initiating the site audit Presentation of positive audit data to Managing Director, Chief Executive Officer and Legal Affairs Production of the Statutory Declaration

Liaison with the General Medical Council and formal hearing


Clinical Data Manager

Medical Adviser/Medical Director Quality Assurance Manager Medical Director

Specialist Investigator appointed or Company Lawyer Specialist Investigator appointed or Company Lawyer

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