The ACRP-authored blog published June 5 (Is CRA Fraud Undermining Clinical Trial Integrity?) generated a flurry of debate. Three issues have become apparent: first, there was some reader misinterpretation of the content and context of the blog; second, there is a clear need for change in education and training; and third, open intellectual conversation should occur.
According to Black’s Law Dictionary, fraud is defined as, “a concealment or false representation through an intentional or reckless statement or conduct that injures another who relies on it in acting.”1 The U.S. Food and Drug Administration defines fraud as, “falsification of data in proposing, designing, performing, recording, supervising, or reviewing research, or in reporting research results.”2 Acts of fraud can include those of omission or commission, and to be considered fraudulent, some type of reward must be provided. The reward can include gifts, financial gain, protection of a position, or promotion. In an effort to connect the definitions given by the law and the FDA, we need to examine the acts of the CRAs whose work was investigated.
Review of work product of 18 CRAs from two global CROs and one sponsor was completed. The review included assessment of tools utilized onsite by CRAs to document monitoring tasks completed; tasks documented in respective monitoring trip reports as ‘completed,’ ‘partially completed,’ or ‘not completed;’ and electronic audit trails. Interim results are as follows:
- Nearly 85% of the CRAs investigated intentionally documented, in monitoring reports, the completion of at least one task that was proven not to have been completed.
- CRA ICF review did not occur based on a lack of reporting of critical ICF process errors. For example, one subject signed ICF twice and was subsequently enrolled in the study as two separate subjects. ICF and enrollment issues were not reported by the CRA in any of six monitoring reports generated over a 14-month period, the ICF tool was not initialed as “completed” by the CRA, but the tasks of ICF and entry criteria verification was documented in the all visit reports as completed. Additionally, the CRA documented in all six reports that the site had two central IRB approved ICF versions, when in fact, there were eight locally approved versions of the ICF. These facts indicate ICFs were not reviewed and repeated documentation of completion of the review support these acts were intentionally false and not mistakes.
- Review of monitoring reports against EDC audit trails revealed 43% of CRAs documented source document verification (SDV) completion in their reports but had not source verified safety data. Safety SDV had not been completed for up to 18 months.
- One CRA marked safety information in EDC as verified. Inspection of the EMR audit trail proved the CRA never logged into the EMR.
These are only a few examples but the results of the investigation made clear the acts of CRAs documenting the completion of review of research in monitoring trip reports is fraudulent. Many readers of the previous blog misunderstood this information to mean that CRAs were documenting ICF process at the site level.
The need for education was apparent from social media and email responses. The initial blog discussed “backdating,” which means to apply an earlier date than the document generation date.3 Backdating of any kind is not acceptable, is subject to citing on Form 483, and is considered fraudulent when attempting to conceal non-compliance. Backdating any monitoring documentation (i.e. follow up letters) is an act of concealment of CRA non-compliance. The investigation revealed 31% of the CRAs regularly backdated follow up letters to conceal their non-compliance.
To the third point, an open intellectual conversation in a professional venue is welcomed. Our industry is one that progresses by way of peer review and evidence-based information. To date, this investigation is the only evidence-based data we have to support change for training and education of all clinical operations staff. The intent of the study is to bring awareness and change.
Although this post does not address all of the information provided in the first blog, it addresses some concerns that were voiced. All data collected and analyzed will be published and will further clarify and support ACRP’s efforts to implement new competencies for clinical operations education. The interim results of this study were presented in May 2017 at the MAGI Conference in Philadelphia.
Author: Guest Blogger Laura LaRosa, RN, MS, President, Sheldon Clinical Trials Consulting, Inc.
- Garner, B. (2014) Black’s Law Dictionary 10th Edition, pg. 775.
- Wollen, S.W. & Hage, A. (2001). Scientific Misconduct. Presentation, slide 3.
- Merriam-Webster Dictionary. (2017). Online.
Editor’s Note: We encourage comment, both on and off the record, addressing this important topic. It is always our intention to provide the best information available and to serve as a virtual “meeting place” across the entire clinical trial spectrum. Please send comments to the Editor-in-Chief at email@example.com.
Voices from the Field
Here’s a sample of what people were saying about Is CRA Fraud Undermining Clinical Trial Integrity? on ACRP’s Facebook page: