The role of the standard operating procedure

With the introduction of good clinical research practice, standard operating procedures now govern all aspects of clinical research. Every company should have a standard operating procedure outlining what is required of its employees in cases of suspected fraud.

Such a standard operating procedure achieves two objectives. Firstly, it can be used to show would-be investigators the company's approach to fraud and thus convince them of the seriousness with which this is viewed by the company. Secondly, it offers some protection, at least in English law, for people who act according to the standard operating procedure, who may be threatened with litigation by persons suspected of committing fraud. This is particularly important in those cases where, on further investigation according to the processes laid out in the standard operating procedure, the suspicion is found to be unfounded.

In order for the limited protection offered by such a standard operating procedure to be maximised, it should clearly and unequivocally state the exact process that should be adopted by someone who has a suspicion that clinical fraud has taken place. It should be unequivocal and allow no deviation from the steps outlined. Further protection can be obtained if the job descriptions of those engaged in clinical research state that compliance with the standard operating procedures currently in force (including the one on fraud) is a requirement for employment.

As well as offering the benefits outlined above, a company standard operating procedure, if properly written, can offer the right advice and guidance to junior staff who have reason to use this procedure, which, we hope, is only rarely called on. The junior clinical research associate who is suspicious of the world-famous professor at a time when all her senior colleagues are on holiday would find a clearly written standard operating procedure of tremendous use.

An example of a standard operating procedure is given in Appendix A.

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