SOCRA CCRP Exam With Confidence Using Practice Dumps

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.

21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.

Ensures subjects are protected and sites stop enrollment.

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.