SOCRA CCRP Exam With Confidence Using Practice Dumps

21 CFR 812.7:Prohibits promotion of investigational devices or claiming safety/effectiveness until FDA approval is granted.

Investigational devices may only be used in clinical trials, not marketed.

Thus, promotion during an IDE study is anFDA violation.

21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.

ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.

Thus, site must first obtainIRB approval for revised protocol and ICF.

Children are avulnerable populationrequiring additional protections.

45 CFR 46.408(a):Requires “adequate provisions for soliciting the assent of the children, when in the judgment of the IRB, the children are capable of providing assent.”

45 CFR 46.402:Defines “assent” as a child’s affirmative agreement to participate.

IRBs must consider theage, maturity, and psychological stateof the children when determining assent capability.

Economic status (B) is irrelevant to assent. Physiological status (C) pertains to eligibility, not assent. Provider notification (D) may be local practice but not required by regulation.

Correct answer:A (Psychological status).