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2026 Reliable CCRP: Certified Clinical Research Professional (CCRP) Trustworthy Exam Torrent

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SOCRA CCRP Exam Syllabus Topics:

Topic
Details

Topic 1

Research Study Closure: This section of the exam measures the skills of Clinical Research Coordinators and covers the activities required to properly conclude a clinical trial. It involves participating in the study closeout visit to verify documentation and account for the investigational product. The domain also includes developing and submitting final closure reports to the IRB, study sponsor, regulatory authorities, and clinicaltrials.gov. Finally, it covers the procedures for archiving study records.

Topic 2

Research Study Start-Up: This section of the exam measures the skills of Clinical Research Coordinators and covers the initial planning and setup of a clinical trial. It involves coordinating the development of the study protocol, ensuring it considers ethical guidelines and regulatory pathways like IND or IDE. It also includes creating essential study documents like informed consent forms and case report forms. The domain covers obtaining necessary approvals from stakeholders like the IRB and sponsor, selecting study sites, training staff, and ensuring the study's compliance with various laws. Additionally, it involves obtaining the research product and preparing all necessary tools and documentation for the study's commencement.|Research Study Implementation: This section of the exam measures the skills of Clinical Research Associates and covers the active management and execution of the clinical trial. It focuses on following the study protocol and standard operating procedures, managing the investigational product, and ensuring ongoing regulatory compliance. The domain includes identifying, documenting, and reporting any study anomalies such as adverse events or protocol deviations. It also involves managing subject recruitment, consent, and retention, as well as maintaining all study records and essential documents. Furthermore, it covers communicating with all study stakeholders and participating in study audits to ensure quality and adherence to regulations.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q60-Q65):

NEW QUESTION # 60
According to the CFR, when children who are wards of the state are enrolled into a clinical trial, what is required?

A. Assenting children must self-represent
B. Each child must have a patient advocate
C. The IRB/IEC must include a member who advocates for the children
D. The investigator must represent the children

Answer: C

Explanation:
Children who are wards of the state receiveadditional protectionsin clinical research.
* 45 CFR 46.409(b):For research involving wards, "the IRB shall require appointment of an advocate for each child, in addition to any guardian or other advocate who would ordinarily be provided."
* The advocate must have background and experience to act in the child's best interest and cannot be associated with the research.
Thus, anIRB-appointed advocateis mandatory to ensure independent representation of the ward's rights.
References:45 CFR 46.409(b).

NEW QUESTION # 61
A Phase I study of a new blood pressure medication has been submitted for initial approval to an IRB/IEC. In accordance with the CFR, the IRB/IEC must consider which of the following criteria when determining whether to approve the study?

A. The equitability of the selection of subjects
B. The availability of the patient population
C. The educational background of the study team
D. The funding source for the trial

Answer: A

Explanation:
When reviewing protocols, IRBs/IECs are primarily responsible forsafeguarding human subjectsby evaluating risks, benefits, and fairness in subject selection.
* 21 CFR 56.111(a)(3):"In making its determination the IRB shall determine that... selection of subjects is equitable."
* 45 CFR 46.111(a)(3):Repeats this requirement, emphasizing fairness across gender, race, age, and socioeconomic status.
Other options:
* Patient population availability (A) is afeasibility issue, addressed by investigators and sponsors, not IRBs.
* Education of the study team (C) is confirmed by thesponsor and investigator, not IRB.
* Funding sources (D) may raise conflict of interest concerns, but they are not IRB approval criteria per federal regulations.
Thus, IRBs focus onjustice and fairness in subject selectionas part of the Belmont Report principles.
References:
21 CFR 56.111(a)(3).
Belmont Report (Justice principle).

NEW QUESTION # 62
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

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 # 63
A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

A. Execute material transfer agreement
B. Notify enrolled subjects
C. Obtain IRB/IEC approval for revised protocol and ICF
D. Ship under dangerous goods requirements

Answer: C

Explanation:
* 21 CFR 56.109(a):IRB must review and approve any protocol amendments before implementation.
* ICH E6(R2) 4.5.2:Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtainIRB approval for revised protocol and ICF.
References:21 CFR 56.109(a); ICH E6(R2) §4.5.2.

NEW QUESTION # 64
Why would a Phase IV study be conducted?

A. Different schedule of administration
B. Different dosage
C. Different marketing strategy
D. Different off-label population

Answer: D

Explanation:
Phase IV studies (post-marketing) examine real-world safety and effectiveness.
* ICH E8(R1):Describes Phase IV as "studies performed after drug approval to delineate additional information including the drug's risks, benefits, and optimal use."
* They often test drugs innew or broader populationsbeyond original approval.
While dosing and schedules are Phase I-III, Phase IV focuses onnew patient populationsor long-term outcomes.
References:ICH E8(R1).

NEW QUESTION # 65
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