Friday, November 27, 2009

Clinical Research Fraud - Investigator Data Identifiers

In my experience, clinical research fraud is pervasive and can be found in many subject data collection systems, source records, subject test results and visit documentation entries at the investigator's clinical trial site. The following are the most common data identifiers:
  • Implausible, impossible, in my view, trends and patterns:
  1. 100% drug compliance
  2. Perfect efficacy responses for all subjects
  3. Identical lab results
  4. Identical ECG results
  5. No SAEs reported
  6. Subjects adhering perfectly to visit schedules.
  • Clinical site data not consistent with other centers (statistical outliers)
  • Perfect diary cards, immaculate subject CRFs
  • All source records & CRFs completed with the same pen
  • Source records lack an audit trail
  • No signatures of persons completing documentation
  • No dates of persons completing documentation
  • Subject handwriting inconsistent across documents (consents, diaries)
  • Subject signature inconsistent across documents (consents, diaries)
  • Questionable subject visit dates (Sundays, holidays, staff vacations)
  • Impossible events (eg, randomization before drug delivery)
  • Data contains "digit preference"
  • Subject visits cannot be verified in the medical chart, appointment schedule or billing records.
How to avoid clinical trial site, staff and investigator fraud?

How to uncover data identifiers?

  • Monitor data.
  • Monitor data.
  • Then Monitor data again.
  • Monitor the Monitors.

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