Misconduct and Fraud in CT-Exercise-I

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Dear members

Initially i thought we will have exercise session after the completion of discussion but i feel we should carry out exercises in between for better understanding of the concept.

EXERCISE-I

Read the case study thoroughly and comment on it.

Case Study A

Site A enrolled 24 patients and was one of the highest recruiting sites in a clinical trial. After the 12th subject enrolled, the Study Coordinator resigned and the sub-investigator continued the study. An audit determined that the completed CRFs for the first 12 subject records were adequately supported by source documentation. However, for the last 12 subjects, although the CRFs had been completed, the source documentation was absent or deficient. When questioned, the sub-investigator stated that the information was on a diskette at his home. He agreed to provide it on the following day. The next day, when asked about the diskette, he stated that there was no diskette, but he had completed the CRFs based

on his photographic memory of the subject visits. The Principal Investigator (PI) was unavailable for questioning by the auditor.

Outcomes:

Three people from the sponsor’s clinical team conducted an in-depth investigation.

The sponsor did not include the non-verifiable data from last 12 subjects in the statistical analysis.

The sponsor determined that it would no longer contract with the contract research organization (CRO) that monitored the site as they did not identify, rectify, or communicate the lack of adherence to GCP standards.

The sponsor concluded that it would no longer invite the PI to participate in clinical trials.

Payment to the PI for the last 12 subjects was withheld.

To the best of the authors’ knowledge, neither the FDA nor the IRB were advised of the audit findings.

Twelve subjects wasted their time and risked their health to no purpose.

Thanks and Regards

Tarun Wadhwa

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