Misconduct and Fraud in CT- solutions to exercise-II

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Dear members

Providing solutions of exercise-II.

EXERCISE-II

Case Study B

Approximately five of the 30 participants that enrolled in the study at Site B completed the study then subsequently re-enrolled at Site B. The PI stated that he did not know this practice was unacceptable and that the participants liked the investigational product so much, he did not see the harm.

Outcomes:

The sponsor provided additional GCP training to the site staff, including the PI.

The sponsor excluded the data from the re-enrolled participants.

When the problems were discovered, the sponsor notified neither the FDA nor the IRB. However, the sponsor reported the incident in the final report to the FDA.

The investigator was not reimbursed for costs associated with the five re-enrolled participants.

The sponsor continued to use the investigational site for future studies.

Five participants wasted their time and risked their health to no purpose.

Comments:

It is the responsibility of the investigator to take care of trial participants if they have been enrolled into the study. Not just for the sake of finishing the enrollment (by any means) by compromising with the health of the participants.

Here investigator re-enrolled five participants into the same study without even thinking of the consequences of such research misconduct. Even sponsor did not inform to IRB or FDA on time. With respect to that, even sponsor was indirectly involved in such a fraud.

It is the responsibility of the sponsor to monitor trial sites regularly for the ethical conduct of research and safety of participants. It is not merely a research but it is ethical way of treating participants with IP for beneficial purpose and ultimately for the benefits of the society.

Participants without their knowledge of harm due to IP after re-enrollment took participation (may be influenced or forced). IRB/IEC should take strict action in such cases to avoid any sort of misconduct which may lead to harm to the participants.

Training of clinical trial personnel do not mean that they are trained enough to carry out research unless and until their activities monitored throughout research.

Thanks and Regards

Tarun Wadhwa

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