clinical research and GCP I …Case Study: Potential Fraud

Whilst conducting SDV during an monitoring visit a CRA finds discrepancies between the visit dates for a patient as recorded in the source notes vs the CRF.  In addition she notices changes in the source notes for another subject which make the subject eligible where it appeared previously that the subject met one of the exclusion criteria.  When she asks the study nurse about the discrepancies the nurse is unable to give an answer.  The investigator has asked his secretary to tell the CRA he has an emergency and is unable to see her that day.

What should the CRA do?  Yes No answers for each of these

Make sure to monitor all patients thoroughly even if it means extending the visit.

•  Yes
•  No

Write to the investigator saying that he should withdraw all subjects and halt recruitment until the issues can be investigated further.

•  Yes
•  No

Write a narrative in the visit report stating that she suspects the investigator is being fraudulent.

•  Yes
•  No

Speak to her manager about her suspicions.

•  Yes
•  No

Arrange another monitoring visit soon and stress the importance of seeing the investigator during the visit.

•  Yes
•  No