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

IRBs/IECs are responsible for ensuring that subject recruitment is ethical and not coercive.

ICH E6(R2) 3.1.2:The IRB/IEC safeguards subjects by reviewing recruitment procedures and materials.

21 CFR 56.111(a)(3):Requires equitable subject selection, which extends to advertisements and recruitment.

FDA Guidance on Recruiting Study Subjects (1998):States that “advertisements and recruitment materials must be reviewed and approved by the IRB prior to use.”

While CVs (D) and lab ranges (A) are essential documents for study feasibility and quality, they are not mandatory for IRB approval package. CRFs (B) are sponsor tools for data collection, not subject-facing, and thus not reviewed by IRBs.

Correct answer:C (Recruitment materials).

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.

TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57(c)and21 CFR 312.62(c).

21 CFR 312.57(c):“A sponsor shall retain the records and reports… for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.

This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.

Thus, the correct answer isA (2 years).

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).

ICH E6(R2) 4.11.1:Investigators must “immediately report all serious adverse events to the sponsor except for those the protocol identifies as not requiring immediate reporting.”

IRB must also be informed promptly per21 CFR 312.64(b).

Follow-up information is submitted later as available.

When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is outlined in both ICH and CFR:

ICH E6(R2) 4.13: “Upon completion of the trial, the investigator should provide the IRB/IEC with a summary of the trial’s outcome.”

21 CFR 312.66: Requires investigators to “report to the IRB all changes in the research activity and all unanticipated problems involving risk, and to provide reports at the end of the study.”

The final report provides closure and documentation that the study was conducted ethically and in compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB submission.

Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study completion, outcome, and compliance with ethical oversight.

Theinvestigatorbears direct responsibility for ensuring IRB/IEC review and approval before initiating a study or implementing any amendments.

ICH E6(R2) 4.4.1:“Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, and any other written information to be provided to subjects.”

21 CFR 312.66:“An investigator shall assure that an IRB that complies with the requirements… will be responsible for the initial and continuing review and approval of the proposed clinical study.”

While sponsors may provide protocol documents, the legal obligation to submit and maintain IRB/IEC approval rests with the investigator at each site. CROs act under sponsor delegation but cannot replace investigator accountability.

Thus, the correct answer isB (The investigator).

ICH E6(R2) 4.5.1:“The investigator should conduct the trial in compliance with the protocol approved by IRB/IEC.”

Deviations must not occur unless to eliminate hazard. Eligibility criteria cannot be overridden by investigator opinion.

Thus, enrollment requires protocol amendment and IRB approval.

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.

Investigators must provideevidence of qualificationsto conduct the study.

ICH E6(R2) 4.1.1:“The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.”

ICH E6(R2) 8.2.10:Essential documents include thecurriculum vitae (CV)or other documents evidencing investigator qualifications, submitted to both sponsor and IRB/IEC.

Proof of citizenship (A) and letters of recommendation (B) are irrelevant. A copy of a medical license (D) may be provided but isnot specifically requiredby ICH. The CV is the universally required document.

Thus, the correct answer isC (Curriculum vitae).