CCRP Exam Dumps : Certified Clinical Research Professional (CCRP)

Form FDA 1572 is the “Statement of Investigator” for IND studies.

21 CFR 312.53(c)(1)(vi)(b):Requires investigators to “read and understand the Investigator’s Brochure.”

By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.

Other options (B–D) are not part of 1572 requirements.

Correct answer:A.

TheBelmont Report (1979)establishedthree key ethical principles:

Respect for Persons:Requires informed consent, recognition of autonomy, and protection of vulnerable individuals.

Beneficence:Obligation to maximize benefits and minimize harm.

Justice:Ensuring fairness in subject selection and distribution of research burdens/benefits.

Voluntary informed consent embodiesRespect for Persons, as subjects are given adequate information and freedom of choice. “Do no harm” (A) is a Hippocratic principle but not Belmont terminology.

Thus, the correct answer isB (Respect for persons).

Informed consent is a fundamental ethical requirement. If it is violated in a device trial, the FDA requires rapid reporting.

21 CFR 812.150(b)(5):States that a sponsor shall submit to FDA “any report of use of a device without obtaining informed consent, within5 working daysafter the sponsor first receives notice of such use.”

This expedited reporting ensures FDA oversight of serious violations and protection of human subjects.

Incorrect options:

A (1 day) is overly strict and not codified.

C (10 days) and D (30 days) are too delayed to meet regulatory intent of immediate oversight.

Thus, the correct timeline iswithin 5 working days.