SOCRA CCRP - Certified Clinical Research Professional (CCRP)

21 CFR 54.4(b):Requires disclosureduring the study and for 1 year after completion.

After three years, no disclosure is required.

Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and howassentis obtained, in addition to parental permission. Exact extracts:

45 CFR 46.408(a): “The IRB shall determine…whether and to what extent children are capable of providing assent.”

ICH E6(R2) 4.8.12: “Where a subject is unable to give consent personally,assent should be obtained when appropriate, in accordance with applicable regulatory requirement(s).”Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not universal requirements for all pediatric research.

ICH E6(R2) 4.6.1:“Responsibility for investigational product accountability at the trial site rests with the investigator.”

May delegate to pharmacist or coordinator, butultimate responsibilitylies with investigator.

IRB/IEC review focuses onethical protection of human subjects. Equitable subject selection is a cornerstone principle.

45 CFR 46.111(a)(3):“In order to approve research… the IRB shall determine that:Selection of subjects is equitable.”

ICH E6(R2) 3.1.2:“The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects… with particular attention to trials that may include vulnerable subjects.”

Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB’s role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.

Thus, the correct answer isB (The selection of subjects is equitable).

The FDA has authority to imposeclinical holds and terminationson IND studies when subject safety is at risk.

21 CFR 312.44(b)(1):“The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury.”

21 CFR 312.42(e):“If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND.”

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer isD (The FDA issued a clinical hold, and 30 days have elapsed).

Retention of essential documents ensures accountability and inspection readiness.

ICH E6(R2) 5.5.12 & 8.1:Sponsors should retain essential documents “until at least2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applicationsor at least 2 years after formal discontinuation of clinical development of the investigational product.”

This standard balances subject protection with practical recordkeeping. Longer durations (B–D) may apply under institutional or national rules, but ICH establishes2 years minimum.

Correct answer:A (2 years).

ICH E6(R2) 5.16:Sponsors must implement ongoing safety evaluation, including expedited and periodic reporting.FDA and IRB review but do not conduct active monitoring.

When reviewing protocols, IRBs/IECs are primarily responsible forsafeguarding human subjectsby evaluating risks, benefits, and fairness in subject selection.

21 CFR 56.111(a)(3):“In making its determination the IRB shall determine that… selection of subjects is equitable.”

45 CFR 46.111(a)(3):Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.

Other options:

Patient population availability (A) is afeasibility issue, addressed by investigators and sponsors, not IRBs.

Education of the study team (C) is confirmed by thesponsor and investigator, not IRB.

Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.

Thus, IRBs focus onjustice and fairness in subject selectionas part of the Belmont Report principles.

IRBs must be diverse and independent to protect human subjects.

21 CFR 56.107(d):“Each IRB shall include at least one member whose primary concerns are in nonscientific areas… andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.”

There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.

Thus, the correct answer isD (At least one unaffiliated individual).