Investigating possible fraudulent activity at a research site
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KeywordsCorrective Action Monitoring Committee Professional Body Systemic Trial Data Monitoring Committee
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.
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)
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:
Were participants real and eligible?
Did they consent?
Are test/clinical measurements/data valid?
Was appropriate treatment/intervention given?
Was follow-up provided, were events reported?
Are participants safe and data reliable?
Obtain documentary evidence, maintaining confidentiality of trial participants
Implement corrective actions to:
Ensure safety of participants
Address important deficiencies in data quality
Support site: training, additional monitoring/support, replace staff.
Look for systemic trial quality issues e.g. other staff, other data
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.
Cases of serious misconduct or fraud do occur. Taking a systematic approach to an investigation ensures appropriate action is taken to preserve study intergrity.
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.