CCRP Exam Questions & Answers

The Belmont Report (1979) established three 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 embodies Respect 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 is B (Respect for persons).

The Belmont Report (1979), Part B: Basic Ethical Principles.

The investigator is directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.

ICH E6(R2) 4.4.1: ''Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, and any other written information to be provided to subjects.''

21 CFR 312.66: ''An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study.''

This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approval at their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.

Thus, the correct answer is C (The investigator).

ICH E6(R2), 4.4.1 (Investigator responsibility before initiation).

21 CFR 312.66 (IRB responsibility in clinical investigations).

ICH E6(R2) 5.13.3: The sponsor is responsible for the supply, storage, and final disposition of investigational product.

21 CFR 312.59: Sponsors must assure return or proper disposition of unused supplies.

Sites must follow sponsor's written procedures for reconciliation, return, or destruction, not IRB or pharmacy processes.

Sponsors must report serious, unexpected, and suspected adverse reactions (SUSARs) to the FDA.

21 CFR 312.32(c)(2): ''Any adverse experience associated with the use of the drug that is both serious and unexpected shall be reported... as soon as possible but no later than 7 calendar days after the sponsor's initial receipt of the information, if it is fatal or life-threatening.''

ICH E2A 4.2: Requires expedited reporting of life-threatening or fatal SUSARs within 7 days.

Among the options, only (C) --- death from arrhythmias not previously identified in the Investigator's Brochure and suspected to be drug-related --- meets the definition of a SUSAR requiring 7-day expedited reporting. Events already listed in the IB (A, D) or unrelated to the drug (B) do not trigger expedited reporting.

Thus, the correct answer is C.

21 CFR 312.32(c)(2) (Expedited safety reporting).

ICH E2A, 4.2 (Expedited reporting of fatal/life-threatening adverse events).

Phase IV studies (post-marketing) examine real-world safety and effectiveness.

ICH E8(R1): Describes Phase IV as ''studies performed after drug approval to delineate additional information including the drug's risks, benefits, and optimal use.''

They often test drugs in new or broader populations beyond original approval.

While dosing and schedules are Phase I--III, Phase IV focuses on new patient populations or long-term outcomes.