Pass the SOCRA Clinical Research Professional CCRP Questions and answers with CertsForce

ICH directs investigators todocument and explainany deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:

ICH E6(R2) 4.5.3: “The investigator should document and explain any deviationfrom the approved protocol.”

ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.Here, absent immediate hazard, the required action is documentation and explanation (B).

The IB must be updatedas new significant safety information emerges.

ICH E6(R2) 7.3:“The sponsor should revise the IB as soon as new, significant information becomes available.”

ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.

A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.

Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.

Thus, the correct answer isB (SUSAR report).

TheInvestigator’s Brochure (IB)is a critical regulatory document designed to provide investigators with comprehensive knowledge about an investigational product.

ICH E6(R2) 7.1:Defines the IB as “a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.”

ICH E6(R2) 7.2.2:Specifies the IB should contain asummary of pharmacological, toxicological, pharmacokinetic, and metabolic studies in animals, as well as results from previous human experience.

The purpose is to allow investigators to makerisk-benefit assessments, support protocol design, and ensure subject safety.

Incorrect options:

A (instructions to conduct study) describes theprotocol, not the IB.

C (financial disclosures) are required under21 CFR 54, not part of the IB.

D refers totrial master file/essential documents, not the IB.

Therefore, the IB’s defining function is to provide ascientific summary of preclinical and clinical datasupporting safe human use.

420 subjects ÷ 42 months (3.5 years) =10 subjects/month.

However, “expected average” often rounds up to next whole number, ensuring enrollment goals are met. Thus,11/monthis correct.

This calculation is important for feasibility assessments and protocol planning.

The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.

21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.

ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.

Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D). Options A and B confuse who signs—subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.

Correct answer:D.

Therisk-benefit ratiois a core responsibility of the IRB/IEC.

21 CFR 56.111(a)(2):“Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.”

ICH E6(R2) 3.1.2:IRB/IEC must safeguard rights, safety, and well-being of subjects, with special attention to risk-benefit evaluation.

Investigators (A) provide medical judgment but do not formally approve the risk-benefit balance. Sponsors (D) design studies but must submit to IRB for independent review. Legal counsel (C) is not part of the scientific/ethical evaluation.

Thus,IRB/IEC is directly responsible for approving the risk-benefit ratio.

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).

Investigators are required to maintain accurate subject records, often referred to ascase histories.

21 CFR 312.62(b):“An investigator shall prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation.”

ICH E6(R2) 4.9.0:Reinforces that investigators are responsible for recording, handling, and storing clinical trial data.

Incorrect options:

B: Investigators may present protocols but cannot vote on IRB approval.

C: Sponsor responsibility (ICH E6 §5.18).

D: Sponsors are responsible for IB updates (ICH E6 §7.3.1).

Correct answer:A.

Minimal risk studiesmay qualify for exemption or expedited review under45 CFR 46.101(b).

45 CFR 46.109(f):“Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review and determined to involve no more than minimal risk.”

ICH E6(R2) 3.1.4:Requires IRB review for clinical trials, but exemptions exist for minimal risk studies.

Therefore, once exempted, there isno requirement for continuing review, unless specifically required by the IRB. Submission at closure is optional depending on institutional policy but not a federal requirement.

Thus, the correct answer isD (No such requirement).

AnInvestigational New Drug (IND) applicationprovides FDA with data to justify human testing.

21 CFR 312.23(a)(3):The IND must contain “a description of the general investigational plan, including the rationale for the drug or the research study.”

The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.

Financial disclosures (D) are reported separately under21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.

Thus, the correct answer isB (Rationale and plan for human testing).