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What is included in the Statement of Investigator (Form FDA 1572)?
Correct Answer: D
FormFDA 1572is the investigator's signed agreement to follow regulations. * 21 CFR 312.53(c)(1)(vi)(c):Requires investigators to sign Form 1572, committing to conduct trials in accordance withFDA regulations (21 CFR 50 & 56). * The form includes commitments to personally supervise, obtain informed consent, maintain records, and permit FDA inspections. It does not include financial disclosures (covered under21 CFR 54) or preclinical data (in theIB). References:21 CFR 312.53(c)(1)(vi)(c).