Historically, clinical research was often analysed with the use of accounting paper, pencil, and rubber. The volumes of data collected were limited and it was possible to look at complete data sets and get a very good "feel for the data". Many experienced statisticians still insist on obtaining this "feel for the data" before subjecting them to statistical analysis.
The introduction of modern computer methods has to a large measure removed manual manipulation of the data.The need to process case record forms as if they are items on a production line, to avoid peaks and troughs of workload in the data group, has exacerbated the problem. Monitoring visits by field staff are often spaced out over many weeks or months, and case record forms will have moved on to the next level within the data processing organisation.
The first suspicion of fraud is often on a "gut feeling" of primary or secondary monitors. In order to encourage this intuitive approach, it is often useful to reacquire all the case record forms relating to a particular doctor or centre and to review them all together. This is particularly the case if there are other grounds for suspicion. This longitudinal review of the data, all in one place and at one time, may draw attention to suspicious similarities that have been missed when individual case record forms have been handled on a one by one basis as they move through the system.
There are many giveaway signs, too many to list here, that may point to forgery or fraud. In one example the use of a distinctive green colour ink to complete the case record forms on approximately 60 patients from three different centres over a six month period was suspicious. Patient diary cards, particularly those requiring the patients to enter data and symptoms or complete questionnaires or visual analogue scales, can be particularly revealing. Similarities in handwriting between "patients" or the way that the "patient" has marked the visual analogue line can often be the clue that initiates a fraud investigation.
Of particular interest is the wide variety of ways that patients choose to mark visual analogue lines if given a free choice, as they normally are; the use of a cross, tick, oblique or horizontal line, or even a bar commencing at one end of the visual analogue scale and finishing at the patient's preferred point will all be seen. Lack of this variability in patient's completed visual analogue scales allegedly coming from different patients should be viewed with great suspicion.
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