[2026年06月06日] 合格させるSOCRA CCRP試験情報と無料練習テスト
CCRP試験問題集PDF更新された問題集にはGoShiken試験合格保証付き
SOCRA CCRP 認定試験の出題範囲：
| トピック | 出題範囲 |
|---|---|
| トピック 1 |
|
| トピック 2 |
|
質問 # 69
A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard.
Before applying this change to all subjects, what must occur?
- A. Obtain IRB/IEC approval
- B. Document change in study file
- C. Inform all subjects
- D. Train sub-investigators
正解：A
解説：
* 21 CFR 812.35(a)(2):Allows deviation without prior approval only to eliminate immediate hazards.
* Before applying broadly,IRB approvalmust be obtained.
References:21 CFR 812.35(a)(2).
質問 # 70
In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?
- A. 24 months
- B. 12 months
- C. 36 months
- D. 6 months
正解：B
解説：
IRBs must review protocols at least annually to ensure ongoing subject protection.
* 21 CFR 56.109(f):"An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year."
* ICH E6(R2) 3.1.4:"The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk, but at least once per year." This establishes12 monthsas the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24-36 months) are not permitted.
Correct answer:B (12 months).
References:
21 CFR 56.109(f).
ICH E6(R2), §3.1.4.
質問 # 71
An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
- A. Sponsor
- B. Research pharmacist
- C. FDA
- D. OHRP
正解：A
解説：
* 21 CFR 812.150(a)(1):Investigators must report unanticipated adverse device effects to thesponsor within 10 working days.
* Sponsor is then responsible for notifying FDA and all investigators.
References:21 CFR 812.150(a)(1).
質問 # 72
In a Phase III cardiovascular trial, who is responsible for ongoing clinical trial safety evaluation?
- A. Sponsor
- B. Pharmacist
- C. IRB/IEC
- D. FDA
正解：A
解説：
* ICH E6(R2) 5.16:Sponsors must implement ongoing safety evaluation, including expedited and periodic reporting.FDA and IRB review but do not conduct active monitoring.
References:ICH E6(R2), §5.16.
質問 # 73
A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?
- A. Only after sponsor and IRB approval
- B. Yes, per protocol
- C. Only after medical monitor approval
- D. Only for a short time, then change to placebo
正解：A
解説：
* ICH E6(R2) 4.5.1:Investigators must follow the protocol approved by the IRB/IEC.
* Any modification that is not pre-specified must be approved by sponsor and IRB before continuing.
Only deviations eliminating immediate hazard can be done without prior approval; in this case, continuation requires sponsor + IRB agreement.
References:ICH E6(R2) §4.5.1.
質問 # 74
An IND application must contain all EXCEPT:
- A. A cover sheet
- B. Investigator's brochure
- C. Chemistry, manufacturing, and control information
- D. Financial disclosure information
正解：D
解説：
* 21 CFR 312.23(a):Requires cover sheet, CMC information, and IB.
* Financial disclosureis required separately under21 CFR 54, not part of IND content.
References:21 CFR 312.23(a); 21 CFR 54.
質問 # 75
Sponsor must maintain drug disposition records for how long after marketing approval?
- A. 3 years
- B. 1 year
- C. 2 years
- D. 5 years
正解：C
解説：
* 21 CFR 312.57(c):"Sponsors shall retain records for2 years after a marketing application is approvedor if not approved, 2 years after shipment and delivery of investigational drug for investigation." References:21 CFR 312.57(c).
質問 # 76
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?
- A. Within 7 working days
- B. Within 10 working days
- C. Immediately
- D. Within 15 working days
正解：C
解説：
ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:
* ICH E6(R2) 4.11.1: "The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol... identifies as not needing immediate reporting." Therefore, "Immediately" (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.
References:
ICH E6(R2) Good Clinical Practice, §4.11.1 (Safety reporting by investigators).===========
質問 # 77
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. Ensuring that all participating investigators are promptly informed of significant new adverse events
- C. Maintaining control of the investigational product
- D. Reporting serious adverse events to the applicable regulatory agency
正解：C
解説：
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.
質問 # 78
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?
- A. It is signed and dated by the IRB/IEC chair
- B. It is signed and dated by the subject's legally authorized representative
- C. It identifies all of the applicable mandated basic elements
- D. It does not identify some of the applicable mandated basic elements
正解：C
解説：
The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
* 21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
* ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D).
Options A and B confuse who signs-subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer:D.
References:
21 CFR 50.25(a).
ICH E6(R2), §4.8.10.
質問 # 79
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 sponsor
- B. The site's legal counsel
- C. The IRB/IEC
- D. The clinical investigator
正解：C
解説：
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.
質問 # 80
A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?
- A. The external source
- B. The sponsor
- C. The investigator/institution
- D. The IRB/IEC
正解：C
解説：
The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff-regardless of employment source. Exact extracts:
* ICH E6(R2) 4.1.1: "The investigator should bequalified... and haveadequate resourcesto properly conduct the trial."
* ICH E6(R2) 4.1.5: "The investigatorshould ensure that all persons assistingwith the trial are adequately informedabout the protocol, the investigational product(s), and their trial-related duties and functions."
* ICH E6(R2) 4.2.5: "The investigatormay delegate... butretains responsibilityfor the conduct of the trial at the site."Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties.
References:
ICH E6(R2) Good Clinical Practice, §4.1.1; §4.1.5; §4.2.5 (Investigator responsibilities; delegation and oversight).===========
質問 # 81
A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?
- A. Available storage square footage
- B. Storage facility temperature range
- C. Storage cost
- D. Number of staff members
正解：B
解説：
Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:
* ICH E6(R2) 5.13.3:"The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s)."
* ICH E6(R2) 4.6.4:"The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product (s) are used only in accordance with the approved protocol." During site qualification/selection, the monitor evaluates storage conditions - particularlytemperature ranges- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.
Thus, the correct answer isC (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.
References:
ICH E6(R2), §5.13.3 (Product storage requirements).
ICH E6(R2), §4.6.4 (Investigator product storage responsibilities).
質問 # 82
According to ICH GCP, an electronic data capture (EDC) system must:
- A. Allow access across multiple platforms
- B. Limit file sharing
- C. Allow for data changes and store audit trails
- D. Limit remote access
正解：C
解説：
* 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.
References:ICH E6(R2), §5.5.3(g).
質問 # 83
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
正解：B
解説：
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)).
質問 # 84
Protecting prisoners' rights to voluntarily participate in research is an example of which Belmont principle?
- A. Justice
- B. Respect for Persons
- C. Beneficence
- D. Dignity
正解：B
解説：
* Belmont Report:"Respect for Persons" incorporates two ethical convictions: treating individuals as autonomous agents and protecting those with diminished autonomy (e.g., prisoners).
* Prisoners require special safeguards because of restricted liberty and potential coercion.
References:Belmont Report (1979).
質問 # 85
Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?
- A. The Declaration of Helsinki
- B. The ICH Guidelines
- C. The Nuremberg Code
- D. The Belmont Report
正解：D
解説：
TheBelmont Report (1979), issued by the U.S. National Commission, identifiesthree core ethical principles guiding human subject research:
* Respect for Persons(informed consent, autonomy, protection of vulnerable populations).
* Beneficence(maximize benefits, minimize harms).
* Justice(fairness in subject selection and treatment).
* TheNuremberg Code (1947)was developed post-WWII to prevent unethical experiments.
* TheDeclaration of Helsinki (1964, updated)is a World Medical Association document guiding international physician research ethics.
* TheICH Guidelines (1996)outline harmonized regulatory requirements for good clinical practice.
Only the Belmont Report fits the description of a U.S.-based, principle-driven framework for human research ethics.
Thus, the correct answer isD (The Belmont Report).
References:
The Belmont Report (1979), National Commission for the Protection of Human Subjects.
45 CFR 46 (Human Subject Protections).
質問 # 86
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 may inspect them only if the IRB/IEC formally requests inspection
- D. The FDA does not have regulatory authority to inspect them
正解：B
解説：
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).
質問 # 87
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
- A. Written information to be provided to the subjects
- B. IRB/IEC requirements for reporting to the regulatory authority
- C. Requirements for storage of the investigational product
- D. Sponsor's SOPs
正解：B
解説：
Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.
* ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.
* Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).
However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor's scope.
That responsibility lies with investigators and IRBs under21 CFR 56.108(b).
Thus, the correct answer isD.
References:
ICH E6(R2), §5.18.4.
21 CFR 56.108(b).
質問 # 88
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
- A. Confirmed that the site's SOPs are in place
- B. Read and understood the investigator's brochure
- C. Obtained malpractice insurance
- D. Completed other relevant research projects
正解：B
解説：
Form FDA 1572 is the "Statement of Investigator" for IND studies.
* 21 CFR 312.53(c)(1)(vi)(b):Requires investigators to "read and understand the Investigator's Brochure."
* By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.
Other options (B-D) are not part of 1572 requirements.
Correct answer:A.
References:
21 CFR 312.53(c)(1)(vi)(b).
質問 # 89
A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?
- A. Program manager
- B. IRB/IEC
- C. Clinical investigator
- D. Sponsor
正解：C
解説：
* ICH E6(R2) 4.2.4:"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, investigational product, and trial-related duties."This responsibility cannot be delegated to sponsor or IRB.
References:ICH E6(R2), §4.2.4.
質問 # 90
The sponsor withdrew an IND due to safety. Who must be notified promptly, in addition to FDA?
- A. Investigational pharmacies
- B. Reviewing IRBs/IECs
- C. Site coordinator
- D. OHRP
正解：B
解説：
* 21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.
* Ensures subjects are protected and sites stop enrollment.
References:21 CFR 312.56(d).
質問 # 91
A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?
- A. Dispensing instructions
- B. Results of recent nude mouse study
- C. Schedule of events
- D. Lab draw requirements
正解：B
解説：
TheInvestigator's Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.
* ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.
* ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.
The "results of recent nude mouse study" (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.
Thus, the correct answer isB (Results of recent nude mouse study).
References:
ICH E6(R2), §7.2.3-7.2.4 (Contents of Investigator's Brochure).
質問 # 92
For a Significant Risk device study, an investigator must report within 5 working days which event?
- A. Emergency deviation
- B. Completion of investigation
- C. Unanticipated adverse effect
- D. Withdrawal of FDA approval
正解：A
解説：
* 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).
質問 # 93
......
あなたを合格させるSOCRA試験にはCCRP試験問題集：https://www.goshiken.com/SOCRA/CCRP-mondaishu.html
CCRP試験問題集でSOCRA練習テスト問題：https://drive.google.com/open?id=1jWwx9Aq7-X2_IKCHOJUAQzsAmCXfMR-r