Fraud and Misconduct

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4. Detection of Misconduct and Fraud

Unintentional misconduct can be best prevented by training people and explaining to them why it is so important that they adhere to the quality standards for the conduct of clinical trials.

The prevention of misconduct must come first. But, if misconduct or fraud occurs despite the setting of these standards and training in their operation, then corrective procedures must be in place.

When misconduct is detected:
  • The problem must be discussed with the person(s) concerned.
  • The reason for the misconduct must be identified.
  • Measures must then be taken to avoid the misconduct happening again.
Who finds fraud and misconduct?

In clinical trials misconduct and fraud are often identified by monitors checking the case report forms (CRFs) and trial performance at the sites. These people are called ‘Clinical Research Associates’ (CRAs). But also the ‘Auditors’ sent to the sites by the sponsors to check the overall study performance and the GCP Inspectors sent by the competent authorities detect these problems. Sometimes suspicious data only become obvious once the statistician checks the overall set of data and detects special ‘patterns’, less variability or lack of outliers.

An important source of fraud and misconduct detection are collaborators and team members. This might be a very difficult situation for them as they may have to blame a colleague, friend or boss of having done something wrong. It is important that these ‘whistle blowers’ receive the required attention and protection.

In an ideal situation, misbehaviour or errors are detected by the researcher himself. People should be encouraged to announce their mistakes. They will only do so if they work in an environment where people are not punished for their mistakes. Instead the reason(s) for the misconduct should be detected and the team should work together to prevent this from happening again.