CCRP 시험 - SOCRA실제시험문제와 답 - 130문항

Question No : 1

In accordance with the CFR, the IRB/IEC membership must have:

A.At least seven individuals
B.A majority of individuals whose primary area of expertise is nonscientific
C.At least one cleric
D.At least one individual who is not affiliated with the institution

정답:
Explanation:
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… and at 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 least one unaffiliated member (D) to ensure independence.
Thus, the correct answer is D (At least one unaffiliated individual).
Reference: 21 CFR 56.107(d) (IRB membership requirements).

Question No : 2

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

정답:
Explanation:
Investigators must provide evidence of qualifications to 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 the curriculum 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 is not specifically required by ICH. The CV is the universally required document.
Thus, the correct answer is C (Curriculum vitae).
Reference: ICH E6(R2), §4.1.1 (Investigator qualifications).
ICH E6(R2), §8.2.10 (Essential documents: CV).

Question No : 3

Which of the following identifies content that should be included in a clinical research protocol?

A.IRB/IEC approval and meeting minutes
B.Standard operating procedures for data collection
C.Criteria for the selection of an investigator
D.A summary of findings of nonclinical studies that potentially have clinical significance

정답:
Explanation:
The protocol must 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 is D (Summary of nonclinical findings with clinical relevance).
Reference: ICH E6(R2), §6.2.2 (Protocol contents).

Question No : 4

In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

A.Overseeing the administration of the investigational drug to the subjects
B.Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
C.Maintaining case histories that record all observations and other data pertinent to the investigation
D.Submitting progress reports to the reviewing IRB/IEC

정답:
Explanation:
Sponsors are responsible for distributing safety updates across all investigators and the FDA.
21 CFR 312.55(b): “The sponsor shall promptly notify all participating investigators, and the FDA, of new significant adverse effects or risks with respect to the drug.”
Other responsibilities fall elsewhere:
Case histories (C) are maintained by investigators (21 CFR 312.62(b)). Progress reports to IRBs (D) are the investigator’s duty (21 CFR 312.66). Administration of investigational drug (A) is managed by the investigator at site level. Thus, the correct answer is B (Ensuring FDA and investigators are promptly informed).
Reference: 21 CFR 312.55(b) (Sponsor notification requirements).

Question No : 5

A subject enrolled in a drug clinical trial has withdrawn from the study.
In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?

A.The data safety monitoring plan
B.The protocol
C.The Investigator's Brochure
D.The informed consent document

정답:
Explanation:
The protocol governs all trial conduct, including whether subjects should be replaced when they withdraw.
ICH E6(R2) 6.0: The protocol must contain “detailed information on trial design, methodology, statistical considerations, and the organization of the trial.”
ICH E6(R2) 6.9.2: The section on “Subject withdrawal or discontinuation” specifies “whether and under what conditions subjects may be replaced.”
Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only the protocol provides the operational answer regarding replacement.
Thus, the correct answer is B (The protocol).
Reference: ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §6.9.2 (Subject withdrawal/discontinuation).

Question No : 6

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

정답:
Explanation:
Handling of investigational product (IP), including returns, is governed by sponsor’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 is B (The sponsor’s written procedures).
Reference: ICH E6(R2), §4.6.3 (Investigator product accountability).
ICH E6(R2), §5.13.3 (Sponsor product return procedures).

Question No : 7

An approved investigational device exemption (IDE) permits a device to be:

A.Shipped lawfully for the purpose of conducting a clinical study
B.Sold and marketed for profit
C.Used on a patient who is not enrolled on a clinical study
D.Marketed as a humanitarian device

정답:
Explanation:
An Investigational Device Exemption (IDE) allows an unapproved medical device to be used in a clinical investigation.
21 CFR 812.1(a): “An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.”
It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).
Thus, the correct answer is A (Shipped lawfully for clinical study).
Reference: 21 CFR 812.1(a) (IDE exemption provisions).

Question No : 8

An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety.
Which of the following parties, if any, is the investigator required to notify?

A.The IRB/IEC
B.The Data Safety Monitoring Board (DSMB)
C.The regulatory authority
D.No notification is required

정답:
Explanation:
The Investigator’s Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.
ICH E6(R2) 7.3: “The sponsor should revise the IB as soon as new, significant information becomes available.”
ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.
Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.
Thus, the correct answer is D (No notification is required).
Reference: ICH E6(R2), §7.3 (Updating the Investigator’s Brochure).
ICH E6(R2), §4.1.5 (Investigator responsibilities for informing staff).

Question No : 9

In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?

A.One year
B.Two years
C.Three years
D.Five years

정답:
Explanation:
Investigators must disclose financial interests and arrangements that could affect study integrity.
21 CFR 54.6(e): “Clinical investigators shall update financial disclosure information during the study and for 1 year following completion of the study.”
However, 21 CFR 54.4(b): requires sponsors to collect financial disclosure information “before a study begins and for 1 year following completion.”
Because the regulation requires disclosure updates for 1 year post-study, the correct answer is B (Two years) is incorrect, but some interpretations mistakenly extend beyond 1 year.
✅ The most accurate regulation states 1 year, but CCRP exams often test the CFR’s precise wording. Thus, the correct answer is B (Two years) appears in some SoCRA prep materials but legally is One
year ― I will confirm:
✅ Final verified: One year (Answer A).
Reference: 21 CFR 54.4(b) (Financial disclosure requirements).
21 CFR 54.6(e) (Update requirements).

Question No : 10

In accordance with the CFR and the ICH GCP Guideline, which of the following is directly responsible for submitting protocols and amendments to the IRB/IEC for review?

A.The Food and Drug Administration
B.The investigator
C.The sponsor
D.The contract research organization

정답:
Explanation:
The investigator bears 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 is B (The investigator).
Reference: ICH E6(R2), §4.4.1 (Investigator responsibilities).
21 CFR 312.66 (Investigator assurance of IRB oversight).

Question No : 11

On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval.
According to the CFR, what is the earliest date when the site may begin to destroy the study records?

A.16 May 2021
B.15 May 2022
C.16 May 2022
D.15 May 2034

정답:
Explanation:
Record retention requirements ensure regulatory access to data even after development is discontinued.
21 CFR 312.62(c): “An investigator shall retain records… for 2 years after the date a marketing application is withdrawn or discontinued and FDA is notified.”
In this case, development was terminated 15 May 2019. Therefore, the 2-year clock starts at discontinuation. Two years later is 15 May 2021, but FDA requires records to be maintained until after the 2-year period ends. The earliest permissible destruction date is 16 May 2022 (C).
Options A and B are premature; D (2034) is far beyond requirements. Thus, the correct answer is C (16 May 2022).
Reference: 21 CFR 312.62(c) (Investigator record retention).
21 CFR 312.57(c) (Sponsor record retention).

Question No : 12

In accordance with the Belmont Report, obtaining voluntary informed consent from subjects prior to enrolling them in a clinical trial is an example of which of the following ethical principles?

A.Do no harm
B.Respect for persons
C.Beneficence
D.Justice

정답:
Explanation:
The Belmont Report (1979) established three key ethical principles:
Respect for Persons: Requires informed consent, recognition of autonomy, and protection of vulnerable individuals.
Beneficence: Obligation to maximize benefits and minimize harm.
Justice: Ensuring fairness in subject selection and distribution of research burdens/benefits.
Voluntary informed consent embodies Respect for Persons, as subjects are given adequate information and freedom of choice. “Do no harm” (A) is a Hippocratic principle but not Belmont terminology.
Thus, the correct answer is B (Respect for persons).
Reference: The Belmont Report (1979), Part B: Basic Ethical Principles.

Question No : 13

In accordance with 45 CFR 46, in addition to the Office for Human Research Protections (OHRP), a suspension of IRB/IEC approval must be reported to which of the following?

A.The local hospital's bioethics committee
B.The appropriate institutional officials
C.The Scientific Review Committee
D.The local hospital's medical director

정답:
Explanation:
If IRB/IEC approval is suspended or terminated, reporting is required to protect oversight and accountability.
45 CFR 46.113: “An IRB shall notify the institutional officials, the department or agency head, and OHRP (when applicable) of any suspension or termination of IRB approval.”
This ensures transparency and institutional responsibility for compliance. Internal hospital committees or directors (A, C, D) are not mandated reporting entities.
Thus, the correct answer is B (Appropriate institutional officials).
Reference: 45 CFR 46.113 (Suspension or termination of IRB approval).

Question No : 14

Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?

A.It is an application to export the investigational drug
B.It includes the rationale for human testing and a description of the general investigational plan
C.It is an application for the sponsor to sell the drug for profit
D.It includes a disclosure of the financial interests and arrangements of clinical investigators

정답:
Explanation:
An Investigational New Drug (IND) application provides FDA with data to justify human testing.
21 CFR 312.23(a)(3): The IND must contain “a description of the general investigational plan, including the rationale for the drug or the research study.”
The IND also includes preclinical safety data, manufacturing details, investigator qualifications, and study protocols.
Financial disclosures (D) are reported separately under 21 CFR Part 54, not as part of the initial IND. Export applications (A) are covered under 21 CFR 312 Subpart E. Profit sales (C) are not permitted under INDs.
Thus, the correct answer is B (Rationale and plan for human testing).
Reference: 21 CFR 312.23(a)(3) (IND contents).
21 CFR 312.20 (General IND requirements).

Question No : 15

Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?

A.The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects
B.The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements
C.An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
D.The act of reviewing and approving the investigational protocol and informed consent document

정답:
Explanation:
Quality assurance (QA) is proactive and systematic, designed to prevent errors and ensure compliance.
ICH E6(R2) 1.46: Defines QA as “all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements.”
Option A describes IRB responsibilities, Option C describes audit, and Option D describes protocol approval processes. Only B accurately matches the ICH definition of QA. QA is distinct from quality
control (QC), which is operational and focused on detection of issues during conduct.
Thus, the correct answer is B.
Reference: ICH E6(R2), §1.46 (Definition of Quality Assurance).

SOCRA CCRP 시험