Clinical Trial Fraud - Questionable Miscellaneous Data

Finally we come to "miscellaneous" data in clinical misconduct and fraud. Miscellaneous data is just that - found everywhere, comment page sections, comment fields, notes, charts, medical history, entry eligibility, etc. There is a trend. If a few miscellaneous data checks are found, for sure, there will be numerous "finds" in data entries and corrections, certainly not according to GCP and Quality Control Audits processes and procedures.

Here are examples of miscellaneous fraudulent clinical data:

• Miscellaneous items in subject binders incriminating
• Difficult to determine PIs involvement
• Reiteration of SC notes
• Corrections are rarely initialed
• Corrections are rarely dated
• CRF Investigator Assessment Page says "not assessed". At a later date, "not assessed" is crossed out and then a reaction is indicated.
• No "person obtaining subject informed consent" signature
• Documents are dated and are signed by employee with dates before the 1st day of employment at the clinical study site
• No GCP training
• Medical History page lists 1st item as a surgery which occurred several months after the subject's enrollment into the clinical study
  
• Clinical chart notes indicate "itching/irritation in TX area". Source documents indicate "none".

Inherent in the trend of miscellaneous data fraud is inconsistency and "forgetting" comments written in a variety of sections and pages during an onsite monitoring visit and/or a subject's scheduled visit according to protocol. Fraudulent data often lacks consistency. Look for the lack of consistency. There is a trail.