CCRP Exam Dumps - SOCRA Clinical Research Professional Questions and Answers

Theprotocolmust provide scientific rationale, including prior nonclinical findings that justify human research.

ICH E6(R2) 6.2.2:“The protocol should include… a summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.”

Other listed options belong elsewhere:

IRB approvals (A) are separate administrative records.

SOPs for data collection (B) are sponsor-level procedural documents.

Investigator selection (C) is a sponsor’s responsibility, not protocol content.

Thus, the correct answer isD (Summary of nonclinical findings with clinical relevance).

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.

Sponsors must reportserious, 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 bothserious and unexpectedshall be reported…as soon as possible but no later than 7 calendar daysafter the sponsor’s initial receipt of the information, if it is fatal or life-threatening.”

ICH E2A 4.2:Requires expedited reporting oflife-threatening or fatal SUSARswithin 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 requiring7-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 isC.

Providing acopy of the signed consent formto subjects is a mandatory requirement.

21 CFR 50.27(a):“A copy shall be given to the person signing the form.”

ICH E6(R2) 4.8.11:Reinforces that “a copy of the signed and dated written informed consent form should be given to the subject.”

Failure to provide this copy constitutes adirect violation of informed consent regulations.

Other issues:

A & C concern proper short form process but do not invalidate informed consent if a copy was provided.

D concerns sponsor template, but the site’s responsibility is ensuring use of IRB-approved version.

Correct answer:B.

Phase classification is based on study objectives, not just subject numbers.

Phase I:Focuses on safety, pharmacokinetics, dose-ranging, usually in healthy volunteers or small patient groups.

Phase II:Evaluateseffectiveness in patients with the conditionand monitors common short-term side effects.

Phase III:Confirms effectiveness in larger populations, compares to standard therapy, gathers more safety data.

Phase IV:Post-marketing studies exploring new indications, long-term safety, or special populations.

The given study aims toevaluate effectiveness and common short-term side effectsin 30 arthritis patients, which clearly aligns withPhase IIobjectives. It is not exploratory safety (Phase I), not confirmatory comparative (Phase III), nor post-marketing (Phase IV).

Thus, the correct answer isB (Phase II).

ICH E6(R2) 4.8.10(n):Consent must include explanation about confidentiality and possible publication.

If not included, specificsubject consentmust be obtained before publishing identifiable results.

Thus, subject’s explicit permission is required.

21 CFR 312.8(b):Sponsors may charge for investigational drugs only if they demonstrate that the drug providespotential clinical benefitand asignificant advantageover existing therapy.

FDA must approve charging requests.

21 CFR 56.109(a):IRBs must review all changes to informed consent before implementation.

ICH E6(R2) 4.8.2:If new information could affect willingness to continue, consent forms must be revised and approved by the IRB.

Even though screening is closed, the IRB/IEC must review the updated form before any subject re-consenting.

Consent forms must present information inlanguage understandable to the subject, avoiding technical jargon.

21 CFR 50.20:“The information… shall be understandable to the subject… and not include any exculpatory language.”

ICH E6(R2) 4.8.6:Information should be presented inlanguage non-technical and understandable to the subject.

Thus, while medical terms (myalgia, arthralgia) are precise, they may not be understandable to laypersons. The correct format useslayman’s terms: “muscle aches, joint pain, and tiredness” (B).

Correct answer:B.

FDA regulations for investigational devices are found under 21 CFR 812. Risk classification determines whether a device is considered Significant Risk (SR) or Non-Significant Risk (NSR). The critical factor is how the device will be used in the specific study.

21 CFR 812.3(m): Defines a “significant risk device study” as one that “is intended as an implant, is purported or represented to be for a use in supporting or sustaining human life, or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.”

Risk is judged within the context of the protocol — i.e., use of the device in that particular study (D).

Number of patients (A), device cost (B), or investigator experience (C) are irrelevant to FDA’s risk classification. For example, a stent used in an approved indication may be NSR, but if used in a new anatomical location, it may be SR.

Therefore, the correct answer is D. This ensures ethical review bodies and FDA assess safety in the intended clinical context rather than device attributes alone.