Investigating possible fraudulent activity at a research site

Background

A risk-based approach to monitoring clinical trials aims to detect non-compliance with the protocol or regulatory requirements that may compromise the participants’ well-being or the trial’s ability to produce reliable results.

Method

We describe a pragmatic framework for investigating and evaluating suspicions of poor performance/practice and the steps to be taken if findings suggest fraudulent activity.

Prior to site audit:

• Check reliability of information that prompted concerns

• Prepare dossier of site information, detailing suspect data points

• Arrange visit promptly (but without indicating concerns)

During audit:

• Two auditors: one to ask open questions, the other as witness and scribe.

• Interview staff individually, establishing their knowledge of trial procedures and incident. Note conflicting information.

• Establish key facts:

• 1. Were participants real and eligible?

• 2. Did they consent?

• 3. Are test/clinical measurements/data valid?

• 4. Was appropriate treatment/intervention given?

• 5. Was follow-up provided, were events reported?

• 6. Are participants safe and data reliable?

• Obtain documentary evidence, maintaining confidentiality of trial participants

• Document findings

After audit:

• Implement corrective actions to:

• 1. Ensure safety of participants

• 2. Address important deficiencies in data quality

• 3. Support site: training, additional monitoring/support, replace staff.

• Look for systemic trial quality issues e.g. other staff, other data

• 1. Apply lessons/corrective actions to the whole trial

• Notify appropriate parties: Sponsor, steering committee, data monitoring committee, regulatory body, ethics board, host institution, funder, and professional bodies.

Conclusion

Cases of serious misconduct or fraud do occur. Taking a systematic approach to an investigation ensures appropriate action is taken to preserve study intergrity.