Free SOCRA CCRP Practice Exam with Questions & Answers

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.

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.

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).

Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:

ICH E6(R2) 5.2.1: “A sponsor may transfer any or all of the sponsor’s trial-related duties… to a CRO,but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.”Hence, D is correct.

21 CFR 54.2(f) & 54.4(a):Requires disclosure of “significant payments of other sorts” (SPOOS) that exceed$25,000or equity interests exceeding$50,000.

However,honoraria or consulting exceeding $10,000 annuallyalso trigger disclosure.

Thus, the reporting threshold is$10,000.

For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.

21 CFR 56.111(a)(3):The IRB must ensure that subject selection is equitable.

21 CFR 50.25(a)(3):Requires disclosure of “any compensation and/or medical treatments available if injury occurs.”

ICH E6(R2) 4.8.10(n):Informed consent should describe “any compensation and/or reimbursement to subjects.”

Thus,compensation amountsmust be reviewed by IRB/IEC to ensure they are not coercive or excessive. Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.

Correct answer:B (The amount of payments and compensation to subjects).

ICH E6(R2) 3.1.2 & FDA Recruitment Guidance (1998):Recruitment materials must be reviewed by IRB to ensure no coercion or misleading claims.

CRFs and storage plans are sponsor/site tools, not IRB-reviewed documents.

Investigators must document the receipt, use, return, or alternative disposition of investigational product (IP).

ICH E6(R2) 4.6.3:Requires investigators to maintain records of IP delivery, inventory, use by subjects, and return/disposition.

ICH E6(R2) 8.2.14–8.2.16:Essential documents include shipment records, accountability logs, and inventory records.

However,certificates of destructionare generated and retained by the sponsor (or authorized destruction facility), not required at the site unless the destruction occurred there. In this scenario, all IP was returned to the sponsor, so no destruction certificate would exist at the site.

Thus, the correct answer isD (Certificate of destruction).

The sponsor holds ultimate responsibility for trial oversight and compliance.

ICH E6(R2) 5.20.1:If noncompliance is discovered, the sponsor must “take prompt action to secure compliance” and, if necessary, terminate participation of the investigator/institution.

21 CFR 312.56(b):Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.

While investigators commit to protocol adherence, once deviations are identified,the sponsor must actto safeguard subjects and trial validity.

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.