| Monitor the data. Monitor the monitor. What do you | | | | 2. Altered |
| monitor - what do you ask for when doing an audit? | | | | 3. Inconsistent. |
| What detection tactics and strategies work? | | | | - Don't be timid - challenge the site to explain |
| - Ask for all subject information (clinical data, docs, | | | | suspected fraudulent data. |
| records) pertinent to the clinical study: | | | | - "Blame-shifting" during on-site audits "for cause" is |
| | | | pervasive |
| 1. CRFs | | | | - Be suspicious and challenge the investigator and |
| 2. Source worksheets | | | | remind he or she that clinical study conduct and GCP |
| 3. Clinical charts | | | | sits with them. |
| 4. Sign-in sheets | | | | - Find and engage and cultivate "whistleblowers" - pay |
| 5. Lab requisitions | | | | attention to - |
| 6. Shipping records. | | | | |
| - Accept no copies, only evaluate originals | | | | 1. Staff complaints |
| | | | 2. Listen to grievances |
| 1. Review originals whenever possible. | | | | 3. Establish rapport be approachable |
| - There is no easy way, don't just inventory and log, | | | | 4. Follow your leads |
| use your experience and understanding - Read - | | | | 5. Don't stray from the data - the data is the data |
| | | | 6. Watch for changes in clinical staff behaviors |
| 1. Lab reports | | | | 7. The list is endless. |
| 2. X-rays. | | | | GCP is well documented and simple to follow - unless |
| - Fraud exists, expect fraud on an audit - assume | | | | there is serious intent to do otherwise. Detect clinical |
| fraud - work backwards. | | | | fraud early in data at a clinical site. The ramifications |
| - Question data, question and follow "open-ended | | | | of doing so saves time and perhaps the integrity of |
| data", "loose-ends" - | | | | the clinical study and/or clinical submission but most |
| | | | importantly protects subject safety, for those |
| 1. Missing | | | | subjects that are real. |