Using CluePoints to Detect Fraud Due to the Fabrication of Patient Diaries

The use of patient diaries is frequently used in clinical research to capture detailed insights directly from participants without oversight by study administrators.

Though highly beneficial, the very nature of this tool leaves it open to the potential for entries to be falsified. A leading pharmaceutical company had been losing confidence in the data being generated through patient diaries at an investigative site involved in a phase III trial in patients with vascular disease.

To verify its concerns, the sponsor used CluePoints' Central Statistical Monitoring solution to provide an assessment of the quality, accuracy and integrity of study data.

Download the case study to discover how CluePoints detected the real issues within this study with suspected fraud in Patient-Reported Outcomes data.