Free Practice Questions for SOCRA CCRP Exam

Minimal risk determination is a regulatory function of the IRB/IEC.

45 CFR 46.102(j):Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.

45 CFR 46.109(a):The IRB has authority to approve, require modifications, or disapprove research, including assessment ofrisk level.

Investigators may propose a study as minimal risk, but only theIRB/IEC can formally classify it.

This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.

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

After three years, no disclosure is required.

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.

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.

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).

Theshort form consent processis permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.

21 CFR 50.27(b)(2):Requires the short form to be signed by the subject (or legally authorized representative)and a witness.

The witness ensures that oral consent was properly conveyed and understood.

The person obtaining consent must sign aseparate written summary, but not the short form itself.

Thus, the accurate answer isA: subject (or LAR) + witness.

ICH E6(R2) 5.5.3(g):Requires audit trails for any data changes, recording date, time, and person responsible.This ensures traceability and regulatory compliance.

Other restrictions (B–D) are not mandated under ICH.

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.

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).