Procedure

5.1 Cases of suspected fraud/misconduct, whoever detects them, will be reported to the line manager of the person concerned.

5.2 If the line manager agrees that a prima facie case for fraud/misconduct exists, he/she will notify the Clinical Quality Assurance Manager.

5.3 If the line manager does not concur with the reporting person's suspicion, there exists the right for the reporting person to communicate directly with the Quality Assurance Manager to avoid collusion.

5.4 The data will be reviewed at a meeting of the Data Manager, the Quality Assurance Manager, the Project Manager/Medical Adviser, and the reporting person under the chairmanship of the Quality Assurance Manager.

5.5 If this meeting does not believe that there is a prima facie case for fraud, a report is issued by the Quality Assurance Manager to the line manager of the reporting person and the reporting person, summarising their reasons for not proceeding. (This process may take five days).

5.6 If a primafacie case exists the following activities are initiated:

5.6.1 The Data Manager is responsible for quarantining the data and adverse drug reactions

5.6.2 The Medical Adviser/Medical Director will review the feasibility of withholding payments and notify the Management Information Systems administrator of the decision.

5.6.3 Data verification audit will be initiated by the Quality Assurance Manager.

The type of audit may vary according to the study in question. It should ideally consist of the Quality Assurance Manager together with the Trial Monitor, Medical Director or Medical Adviser. It may, in the case of post-marketing surveillance, be only the Trial Monitor responsible for that area.

5.7 A formal report of the data verification audit is issued.The following activities may then be initiated:

5.7.1 If fraud/misconduct is not confirmed at audit, any further action is at the discretion of the Medical Director/Medical Adviser.

5.7.2 If clinical fraud/misconduct is confirmed at audit a formal report is issued to the Medical Director.

5.8 On receipt of this report the Medical Director will set up a meeting with the Managing Director, the Chief Executive Officer, and a representative of Legal Affairs, and will brief them on the case to date.

This whole procedure, from the first suspicion of fraud/misconduct to the briefing of the Chief Executive Officer will take no more than 25 working days.

5.9 Following the briefing of the senior executives' meeting and assuming a decision to proceed, it is the responsibility of the Medical Director to prepare a Statutory Declaration.

5.10

The Statutory Declaration should be sent to the General Medical Council.

If the preliminary screener at the General Medical Council (GMC) believes that the case should proceed it may be sent to the Preliminary Proceedings Committee under the GMC procedure rules. A decision as to future progress rests with that committee who may:

a) take no further action b) send a warning letter to the respondent doctor c) refer to the Health Committee if appropriate d) refer to the Professional Conduct Committee for a full hearing.

5.10.3 The complainant company will be notified by the GMC as to progress of the case.

5.11 Company Medical Directors are advised to inform the Medical Director of the Association of the British Pharmaceutical Industry of any investigator they suspect of research misconduct. The ABPI Medical Director will be in a position to advise the company on how to proceed.

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