Misconduct and Fraud in CT

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Dear members

Failed to obtain informed consent of each human subject in accordance with 21 CRF 50 [21 CRF 312.60]

Lab samples drawn prior to signing and dating the ICF

IRB approved ICF required actual time in which legally effective IC was obtained. No documentation of the actual time. Unable to verify subjects signed & dated prior to protocol specific procedures being conducted on

them

ICF not approved by IRB

ICF not signed prior to implanting investigational device

No written documentation that IC was obtained

IRB approved a 3 page document. Found subjects who were consented with a 1 page ICF and unapproved ICF’s

IRB approved ICF signed after study device was utilized

Subject signed consent form for incorrect study

Consent not signed until 11 days after study related procedure. Handwritten note states, “I was informed about study and risk-did not sign consent 6-26-03â€

No documentation that subject was given copy of the signed informed consent

Regards

Tarun Wadhwa

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