- Ask for all subject information (clinical data, docs, records) pertinent to the clinical study:
- CRFs
- Source worksheets
- Clinical charts
- Sign-in sheets
- Lab requisitions
- Shipping records.
- Accept no copies, only evaluate originals
- Review originals whenever possible.
- There is no easy way, don’t just inventory and log, use your experience and understanding – Read -
- Lab reports
- X-rays.
- Fraud exists, expect fraud on an audit – assume fraud – work backwards.
- Question data, question and follow “open-ended data”, “loose-ends” -
- Missing
- Altered
- Inconsistent.
- Don’t be timid – challenge the site to explain suspected fraudulent data.
- “Blame-shifting” during on-site audits “for cause” is pervasive
- Be suspicious and challenge the investigator and remind he or she that clinical study conduct and GCP sits with them.
- Find and engage and cultivate “whistleblowers” – pay attention to -
- Staff complaints
- Listen to grievances
- Establish rapport be approachable
- Follow your leads
- Don’t stray from the data – the data is the data
- Watch for changes in clinical staff behaviors
- The list is endless.
GCP is well documented and simple to follow – unless there is serious intent to do otherwise. Detect clinical fraud early in data at a clinical site. The ramifications of doing so saves time and perhaps the integrity of the clinical study and/or clinical submission but most importantly protects subject safety, for those subjects that are real.
Diane L. Mauriello, PhD is the President of Dante Resources, Inc. a global clinical research organization.
Diane, who has been called as an expert witness in clinical trial fraud cases and has close to 25 years in the medical, science, pharmaceuticals field.
For more expert incites from Diane, please visit Dante Resources clinical research blog for focused discussion on topics related to clinical trials and successful regulatory submissions.
