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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q77-Q82):

NEW QUESTION # 77
Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

A. The IRB/IEC
B. The Department of Health and Human Services
C. The FDA or another regulatory authority
D. No approvals are necessary if no pharmaceutical drugs are involved

Answer: A

Explanation:
Even if a study does not involve drugs, devices, or biologics, it still involveshuman subjectsand therefore requiresethical review by an IRB/IEC.
* 45 CFR 46.109(a):"An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects." Quality-of-life (QOL) studies may involve surveys, interviews, or questionnaires, but since they involve human participants, they are subject to human research protection regulations. FDA involvement is not required unless drugs or devices are tested. Similarly, HHS approval is not required unless the study is federally funded.
Thus, the correct answer isC (The IRB/IEC).
References:
45 CFR 46.109(a) (IRB review of research).
ICH E6(R2), §3.1.2 (IRB/IEC role in subject protection).

NEW QUESTION # 78
In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?

A. The sponsor's written procedures
B. The Investigator's Brochure
C. The investigational pharmacy's requirements
D. The CRO/site agreements

Answer: A

Explanation:
Handling of investigational product (IP), including returns, is governed bysponsor's written procedures.
* ICH E6(R2) 4.6.3:"The investigator/institution should maintain records of the product's delivery, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."
* ICH E6(R2) 5.13.3:"The sponsor should ensure that written procedures include instructions for... the return or alternative disposition of unused product(s)." The IB (A) describes pharmacology and safety, not IP logistics. CRO agreements (C) cover contractual duties, not product return processes. Local pharmacy policies (D) may apply operationally but do not override sponsor-required procedures.
Thus, the correct answer isB (The sponsor's written procedures).
References:
ICH E6(R2), §4.6.3 (Investigator product accountability).
ICH E6(R2), §5.13.3 (Sponsor product return procedures).

NEW QUESTION # 79
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?

A. Suggestions for a new trial design
B. Recommendations to stop a trial
C. An initial review and approval of a trial
D. The selection of qualified investigators

Answer: B

Explanation:
AnIndependent Data Monitoring Committee (IDMC or DSMB)is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.
* ICH E6(R2) 5.5.1:"The sponsor may consider establishing anindependent data-monitoring committee (IDMC)to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial." Thus, DSMBs/IDMCsdo not perform trial approvals (A),do not design trials (C), anddo not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.
Therefore, the correct answer isB (Recommendations to stop a trial).
References:
ICH E6(R2), §5.5.1 (Independent Data Monitoring Committees).

NEW QUESTION # 80
Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?

A. The investigator's clinical trial agreement with the sponsor
B. The amount of payments and compensation to subjects
C. The drug development and marketing plan
D. The itemized study budget

Answer: B

Explanation:
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).
References:
21 CFR 50.25(a)(3).
ICH E6(R2), §4.8.10(n).

NEW QUESTION # 81
A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?

A. A curriculum vitae
B. A copy of medical license
C. A letter of recommendation from a fellow physician
D. Proof of citizenship

Answer: A

Explanation:
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).
References:
ICH E6(R2), §4.1.1 (Investigator qualifications).
ICH E6(R2), §8.2.10 (Essential documents: CV).

NEW QUESTION # 82
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