Jun-2026 Free SOCRA CCRP Exam Question Practice Exams
Ace CCRP Certification with 132 Actual Questions
NEW QUESTION # 79
After completion of a Phase III trial, which document should IRB/IEC retain?
- A. Investigational product labels
- B. Sponsor/investigator contracts
- C. Occupations and affiliations of IRB members
- D. Subject enrollment logs
Answer: C
Explanation:
* 21 CFR 56.115(a)(5):IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).
* Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB's.
References:21 CFR 56.115(a)(5).
NEW QUESTION # 80
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
- A. The clinical investigator
- B. The medical monitor
- C. The reviewing IRB/IEC
- D. A data safety monitoring board
Answer: C
Explanation:
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.
References:45 CFR 46.102(j), 46.109(a).
NEW QUESTION # 81
A study will enroll 420 subjects over 3.5 years. What is expected average monthly accrual?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: B
Explanation:
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.
References:Standard feasibility calculations (ICH E6(R2) §5.6).
NEW QUESTION # 82
Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?
- A. Ensuring proper monitoring of an investigation at all investigational sites
- B. Maintaining control of the investigational product
- C. Reporting serious adverse events to the applicable regulatory agency
- D. Ensuring that all participating investigators are promptly informed of significant new adverse events
Answer: B
Explanation:
For non-sponsor investigators, responsibilities are limited tosite-level conduct and product accountability.
* ICH E6(R2) 4.6.1:"Responsibility for investigational product(s) accountability at the trial site rests with the investigator/institution."
* 21 CFR 312.61:Requires the investigator to administer investigational drugs only to subjects under their supervision and maintain control.
Other responsibilities listed belong tosponsors:
* A: Reporting SAEs to FDA is a sponsor duty (investigators report to sponsor, not directly to FDA).
* B: Monitoring at all sites is a sponsor responsibility.
* C: Disseminating safety updates is a sponsor's role.
Correct answer:D (Maintaining control of IP).
References:
ICH E6(R2), §4.6.1.
21 CFR 312.61.
NEW QUESTION # 83
Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?
- A. The FDA may inspect them at reasonable times, in a reasonable manner, but may not take copies unless requested with an affidavit
- B. The FDA may inspect them at reasonable times, in a reasonable manner, and may take copies of IRB
/IEC records - C. The FDA does not have regulatory authority to inspect them
- D. The FDA may inspect them only if the IRB/IEC formally requests inspection
Answer: B
Explanation:
The FDA has full regulatory authority to inspect IRB/IEC records.
* 21 CFR 56.115(b):"The IRB shall permit representatives of the Food and Drug Administration to inspect and copy all records maintained... at reasonable times and in a reasonable manner." Thus, FDA mayinspect and copyIRB/IEC records without requiring an affidavit or invitation. This ensures regulatory oversight and human subject protection.
Incorrect options:
* (A) limits authority incorrectly.
* (C) is false - FDA explicitly regulates IRBs.
* (D) is false - FDA does not need IRB invitation.
Correct answer:B.
References:
21 CFR 56.115(b).
NEW QUESTION # 84
For a Significant Risk device study, an investigator must report within 5 working days which event?
- A. Withdrawal of FDA approval
- B. Completion of investigation
- C. Emergency deviation
- D. Unanticipated adverse effect
Answer: C
Explanation:
* 21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well- being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.
* Unanticipated adverse device effects have a 10-day reporting window.
References:21 CFR 812.150(a)(4).
NEW QUESTION # 85
Upon completion of a study, the investigator should do which of the following?
- A. Ensure that all payments from sponsor have been received
- B. As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome
- C. Provide the IRB/IEC a final report, but only if the study has a positive outcome
- D. Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report
Answer: B
Explanation:
Investigators must formally close out a trial with the IRB/IEC.
* ICH E6(R2) 4.13.2:"Upon completion of the trial, the investigator/institution should provide the IRB
/IEC with a summary of the trial's outcome."
* 21 CFR 312.66:Reinforces investigator's duty to keep IRB informed throughout study lifecycle.
This applies regardless of whether outcomes were positive, negative, or inconclusive. IRBs are not concerned with sponsor payments (B) or publications (D).
Thus, the correct answer isA (Provide final report to IRB/IEC).
References:
ICH E6(R2), §4.13.2 (Final reporting requirement).
NEW QUESTION # 86
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?
- A. Once a year until study close-out
- B. Every 4-6 weeks until study close-out
- C. In a timely manner before, during, and after the study
- D. At least weekly
Answer: C
Explanation:
Monitoring ensures trial integrity and subject safety.
* ICH E6(R2) 5.18.3:"The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial."
* Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).
It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible, but must cover all phases of the study.
Correct answer:C (Timely manner before, during, and after).
References:
ICH E6(R2), §5.18.3.
NEW QUESTION # 87
A research site was invited to participate in an investigational drug study. Which of the following parties is responsible for determining the risk-benefit ratio at the site?
- A. The site's legal counsel
- B. The clinical investigator
- C. The IRB/IEC
- D. The sponsor
Answer: C
Explanation:
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.
References:
21 CFR 56.111(a)(2).
ICH E6(R2), §3.1.2.
NEW QUESTION # 88
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. Proof of citizenship
- B. A curriculum vitae
- C. A copy of medical license
- D. A letter of recommendation from a fellow physician
Answer: B
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 # 89
In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:
- A. Maintain accurate records throughout retention
- B. Generate audit trails
- C. Print a complete paper copy
- D. Customize access rights
Answer: C
Explanation:
* 21 CFR 11.10:Requires validation, audit trails, secure access, but does not mandate printing capability.
Thus, (D) is the exception.
References:21 CFR 11.10.
NEW QUESTION # 90
In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB
/IEC will conduct the initial and continuing review of a study?
- A. The monitor
- B. The investigator
- C. The study coordinator
- D. The sponsor
Answer: B
Explanation:
Theinvestigatoris directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.
* 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, consent form updates, 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." This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approvalat their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.
Thus, the correct answer isC (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibility before initiation).
21 CFR 312.66 (IRB responsibility in clinical investigations).
NEW QUESTION # 91
In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?
- A. 0
- B. 1
- C. 2
- D. 3
Answer: A
Explanation:
This question tests drug accountability and dosing calculation, which is central to ICH E6(R2) 4.6 (Investigational product management). Subjects must receive the correct supply and any discrepancy must be reconciled.
The prescribed regimen is 2 mg twice daily = 4 mg per day. With 1 mg tablets, this equals 4 tablets daily.
Over 10 days, the subject should consume 40 tablets (4 × 10 = 40). Since 45 tablets were dispensed, the subject should have 5 tablets remaining after 10 days.
Accurate accountability ensures trial integrity and subject safety. Investigators are responsible for maintaining investigational product (IP) records, including dispensing, usage, and returns. According to ICH:
4.6.3: "The investigator/institution should maintain records of the product's delivery to the trial site, the inventory, the use by each subject, and the return to the sponsor or alternative disposition."
4.6.5: "The investigator should ensure that investigational products are used only in accordance with the approved protocol." Thus, the correct answer is C (5 tablets remain). This reflects proper dosing compliance and highlights the importance of meticulous IP tracking in clinical trials.
References:
ICH E6(R2), §4.6 (Investigational Product(s)).
NEW QUESTION # 92
In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?
- A. 10 days
- B. 15 days
- C. 1 day
- D. 7 days
Answer: D
Explanation:
Serious adverse events are subject to expedited reporting requirements.
* ICH E2A 3.2.2:"Fatal or life-threatening unexpected ADRs should be reported as soon as possible but no later than7 calendar daysafter first knowledge."
* ICH E2A 3.2.3:Other serious unexpected events must be reported within 15 days.
Thus, the 7-day rule applies tolife-threatening and unexpected events(as in this case).
Correct answer:B (7 days).
References:
ICH E2A, §3.2.2.
NEW QUESTION # 93
A study coordinator is preparing an IRB submission for a Phase II oncology study. Which document must be included?
- A. Case report forms
- B. Recruitment materials
- C. List of potential subjects
- D. Record storage plan
Answer: B
Explanation:
* 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.
References:ICH E6(R2) §3.1.2; FDA Recruitment Guidance, 1998.
NEW QUESTION # 94
......
SOCRA CCRP Exam Syllabus Topics:
| Topic | Details |
|---|---|
| Topic 1 |
|
| Topic 2 |
|
CCRP Questions PDF [2026] Use Valid New dump to Clear Exam: https://actualtorrent.exam4pdf.com/CCRP-dumps-torrent.html
