Investigating possible fraudulent activity at a research site

• 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: 1. Were participants real and eligible? 2. Did they consent? 3. Are test/clinical measurements/data valid? 4. Was appropriate treatment/intervention given? 5. Was follow-up provided, were events reported? 6. Are participants safe and data reliable? • Obtain documentary evidence, maintaining confidentiality of trial participants • Document findings