CCRP Exam Dumps - Certified Clinical Research Professional (CCRP)

21 CFR 812.150(a)(1):Investigators must report unanticipated adverse device effects to thesponsorwithin 10 working days.

Sponsor is then responsible for notifying FDA and all investigators.

IRBs must review protocols at least annually to ensure ongoing subject protection.

21 CFR 56.109(f):“An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.”

ICH E6(R2) 3.1.4:“The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk, but at least once per year.”

This establishes12 monthsas the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24–36 months) are not permitted.

Correct answer:B (12 months).

Phase classification is based on study objectives, not just subject numbers.

Phase I:Focuses on safety, pharmacokinetics, dose-ranging, usually in healthy volunteers or small patient groups.

Phase II:Evaluateseffectiveness in patients with the conditionand monitors common short-term side effects.

Phase III:Confirms effectiveness in larger populations, compares to standard therapy, gathers more safety data.

Phase IV:Post-marketing studies exploring new indications, long-term safety, or special populations.

The given study aims toevaluate effectiveness and common short-term side effectsin 30 arthritis patients, which clearly aligns withPhase IIobjectives. It is not exploratory safety (Phase I), not confirmatory comparative (Phase III), nor post-marketing (Phase IV).

Thus, the correct answer isB (Phase II).

TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principlesguiding human subject research:

Respect for Persons(informed consent, autonomy, protection of vulnerable populations).

Beneficence(maximize benefits, minimize harms).

Justice(fairness in subject selection and treatment).

TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.

TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.

TheICH Guidelines (1996)outline harmonized regulatory requirements for good clinical practice.

Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.

Thus, the correct answer isD (The Belmont Report).

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).