Saturday, November 28, 2009

Questionable Data in Clinical Fraud - Photos, Drug and Supplies

Often the question arises from the sponsor or a concerned clinical site team member - "There is so much data collected per subject per clinical study protocol at the clinical study site, where do we look for questionable data?"

Areas that one may find questionable data are numerous and in my view and years of experience - I can offer hundreds of locations and ideas. As well, I (colleagues) will not be surprised to uncover more areas where questionable data arises in the future.

At this writing, I will share common and not so common areas of questionable data at clinical trial sites suspected of clinical misconduct and fraud, starting with Photos, Drug and Supplies:
  • Photos
  1. Placards indicated different subject numbers but photos are of the same subject
  2. TX area on source documents and CRFs differs from photos - for example cheek vs. back of head
  3. Screening photo shows reaction in TX area - subject already dosing?
  4. Dates on photos do not agree with visit #
  5. Fraudulent photos
  6. Missing photos
  • Drug Log and Supplies
  1. Incorrect subject initials on drug boxes - initials of subject not in our study
  2. Date on drug log and drug box different
  3. No dates dispensed on drug boxes and/or labels in CRF
  4. Drug dispensing log - no entries for several months***
  5. Drug dispensing log indicates drug dispensed, however drug boxes are still in inventory
  6. Date of drug dispensed pre-dated -----after date of audit
  7. Emergency supplies have wrong subject initials on box
  8. Drug dispensing forms were pre-dated.
***At the time/visit on dispensing drug to subjects - the drug dispensing log and forms must be filled out at that time. This is GCP regardless of misconduct. This is true for any observation while subject is onsite, on-study. Fill in the appropriate information at the time of that visit - do not wait.

More to come in the next blog - Diary, Source Documents, Lab information.

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