Mar-2026 SOCRA CCRP Certification Real 2026 Mock Exam
CCRP Exam Questions and Valid PMP Dumps PDF
NEW QUESTION # 76
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
- A. The clinical investigator
- B. A data safety monitoring board
- C. The reviewing IRB/IEC
- D. The medical monitor
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 # 77
According to 21 CFR Part 11, each electronic signature must be unique and:
- A. Cannot be reused or reassigned
- B. Identical to handwritten signature
- C. Transferable to family
- D. Reassignable after validation
Answer: A
Explanation:
* 21 CFR 11.100(a):Requires that electronic signatures be "unique to one individual and shall not be reused or reassigned to anyone else."
* This ensures accountability and audit trail integrity.
References:21 CFR 11.100(a).
NEW QUESTION # 78
During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:
- A. Assign another investigator to perform sample collections until an internal investigation is completed
- B. Immediately report the observation to the regulatory authority
- C. Suspend all trial-related activities until the events of the deviation have been mitigated
- D. Document and explain the deviation from the protocol
Answer: D
Explanation:
ICH directs investigators todocument and explainany deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:
* ICH E6(R2) 4.5.3: "The investigator should document and explain any deviationfrom the approved protocol."
* ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.Here, absent immediate hazard, the required action is documentation and explanation (B).
References:
ICH E6(R2) Good Clinical Practice, §4.5.3 (Compliance with protocol; deviations).
ICH E6(R2) §3.3.7; §4.5.2 (Reporting deviations implemented to eliminate immediate hazards).
NEW QUESTION # 79
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 protocol
- B. The data safety monitoring plan
- C. The Investigator's Brochure
- D. The informed consent document
Answer: A
Explanation:
Theprotocolgoverns 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 theprotocolprovides the operational answer regarding replacement.
Thus, the correct answer isB (The protocol).
References:
ICH E6(R2), §6.0 (Protocol content).
ICH E6(R2), §6.9.2 (Subject withdrawal/discontinuation).
NEW QUESTION # 80
In accordance with the CFR, the IRB/IEC membership must have:
- A. A majority of individuals whose primary area of expertise is nonscientific
- B. At least seven individuals
- C. At least one cleric
- D. At least one individual who is not affiliated with the institution
Answer: D
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... 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).
References:
21 CFR 56.107(d) (IRB membership requirements).
NEW QUESTION # 81
For a Significant Risk device study, an investigator must report within 5 working days which event?
- A. Completion of investigation
- B. Emergency deviation
- C. Withdrawal of FDA approval
- D. Unanticipated adverse effect
Answer: B
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 # 82
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. Respect for persons
- B. Do no harm
- C. Justice
- D. Beneficence
Answer: A
Explanation:
TheBelmont Report (1979)establishedthree 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 embodiesRespect 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 isB (Respect for persons).
References:
The Belmont Report (1979), Part B: Basic Ethical Principles.
NEW QUESTION # 83
An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?
- A. Research pharmacist
- B. Sponsor
- C. OHRP
- D. FDA
Answer: B
Explanation:
* 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).
NEW QUESTION # 84
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 ICH Guidelines
- B. The Declaration of Helsinki
- C. The Belmont Report
- D. The Nuremberg Code
Answer: C
Explanation:
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).
NEW QUESTION # 85
In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties andfunctions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?
- A. The IRB/IEC
- B. The sponsor
- C. The CRO
- D. The investigator
Answer: B
Explanation:
Outsourcing does not shift ultimate responsibility away from the sponsor. Exact extract:
* ICH E6(R2) 5.2.1: "A sponsor may transfer any or all of the sponsor's trial-related duties... to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor."Hence, D is correct.
References:
ICH E6(R2) Good Clinical Practice, §5.2.1 (Sponsor/CRO).===========
NEW QUESTION # 86
A sponsor became aware of a new serious adverse event related to a drug. Who must be notified in addition to FDA?
- A. All participating investigators
- B. OHRP
- C. All IRBs/IECs of record
- D. All investigational pharmacists
Answer: A
Explanation:
* 21 CFR 312.32(c)(1)(ii):Sponsors must notifyall participating investigatorsof any serious and unexpected suspected adverse reactions.
* Investigators then inform IRBs and subjects as appropriate.
References:21 CFR 312.32(c)(1)(ii).
NEW QUESTION # 87
In accordance with the ICH GCP Guideline, who is responsible for ensuring that all study site personnel working on a clinical trial are qualified to conduct the trial?
- A. The clinical investigator
- B. The sponsor
- C. The clinical research coordinator
- D. The study monitor
Answer: A
Explanation:
The investigator has ultimate responsibility for site staff qualifications.
* ICH E6(R2) 4.2.4:"The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product, and their trial-related duties and functions."
* ICH E6(R2) 4.1.5:Investigator must maintain current documentation of staff qualifications.
While sponsors and monitors oversee compliance, accountability rests with theclinical investigator.
Coordinators may implement duties, but do not hold legal responsibility.
Correct answer:B (The clinical investigator).
References:
ICH E6(R2), §4.2.4.
ICH E6(R2), §4.1.5.
NEW QUESTION # 88
Sponsor must maintain drug disposition records for how long after marketing approval?
- A. 5 years
- B. 3 years
- C. 2 years
- D. 1 year
Answer: C
Explanation:
* 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).
NEW QUESTION # 89
An approved investigational device exemption (IDE) permits a device to be:
- A. Marketed as a humanitarian device
- B. Sold and marketed for profit
- C. Shipped lawfully for the purpose of conducting a clinical study
- D. Used on a patient who is not enrolled on a clinical study
Answer: C
Explanation:
AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical 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 isA (Shipped lawfully for clinical study).
References:
21 CFR 812.1(a) (IDE exemption provisions).
NEW QUESTION # 90
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 local hospital's medical director
- D. The Scientific Review Committee
Answer: B
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 theinstitutional 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 isB (Appropriate institutional officials).
References:
45 CFR 46.113 (Suspension or termination of IRB approval).
NEW QUESTION # 91
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. Read and understood the investigator's brochure
- B. Obtained malpractice insurance
- C. Confirmed that the site's SOPs are in place
- D. Completed other relevant research projects
Answer: A
Explanation:
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).
NEW QUESTION # 92
A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?
- A. After sponsor revises eligibility and IRB approves amendment
- B. After repeat test confirms 1.6
- C. After investigator documents explanation in chart
- D. After monitor approves deviation
Answer: A
Explanation:
* 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.
References:ICH E6(R2), §4.5.1.
NEW QUESTION # 93
A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?
- A. $5,000
- B. $10,000
- C. >$25,000
- D. Any amount
Answer: B
Explanation:
* 21 CFR 54.2(f) & 54.4(a):Requires disclosure of "significant payments of other sorts" (SPOOS) that exceed$25,000or equity interests exceeding$50,000.
* However,honoraria or consulting exceeding $10,000 annuallyalso trigger disclosure.
Thus, the reporting threshold is$10,000.
References:21 CFR 54.2(f), 54.4(a).
NEW QUESTION # 94
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?
- A. At least weekly
- B. Once a year until study close-out
- C. Every 4-6 weeks until study close-out
- D. In a timely manner before, during, and after the study
Answer: D
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 # 95
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SOCRA CCRP Exam Syllabus Topics:
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