Box 71 Basis for disqualification

• Repeated or deliberate submission of false data to the sponsor and the FDA (21 CFR 312.70)

• Failure to obtain IRB approval and comply with IRB regulation (21 CFR 56)

• Failure to obtain informed consent (21 CFR 50)

• Failure to sign investigator's statement form FDA 1572 (21 CFR 312.60)

• Failure to follow protocol (21 CFR 312.60)

• Failure to administer drug or under principal investigator supervision (21 CFR 312.61)

• Inadequate record keeping requirements (21 CFR 312.62)

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