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SOCRA CCRP Exam Syllabus Topics:

Topic
Details

Topic 1

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.

Topic 2

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.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q61-Q66):

NEW QUESTION # 61
After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?

A. The IRB/IEC
B. The sponsor
C. The study coordinator
D. The investigator

Answer: B

Explanation:
Monitoring reports are sponsor-controlled documents.
* ICH E6(R2) 5.18.6:"The monitor should submit a written report to the sponsor after each trial-site visit... The sponsor should review and follow up on the monitoring report."
* ICH E6(R2) 8.1 & 8.2.22:Monitoring visit reports are essential documents maintained by the sponsor.
Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.
Thus, the correct answer isB (The sponsor).
References:
ICH E6(R2), §5.18.6 (Monitoring reports).
ICH E6(R2), §8.2.22 (Essential documents: monitoring visit reports).

NEW QUESTION # 62
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 monitor approves deviation
B. After investigator documents explanation in chart
C. After sponsor revises eligibility and IRB approves amendment
D. After repeat test confirms 1.6

Answer: C

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 # 63
According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB after completion of the trial at the site?

A. The final subject enrollment log
B. The monitoring close-out visit report
C. The data safety monitoring summary
D. The final report

Answer: D

Explanation:
When a trial ends at a site, the investigator has an obligation to submit a final report to the IRB/IEC. This is outlined in both ICH and CFR:
ICH E6(R2) 4.13: "Upon completion of the trial, the investigator should provide the IRB/IEC with a summary of the trial's outcome."
21 CFR 312.66: Requires investigators to "report to the IRB all changes in the research activity and all unanticipated problems involving risk, and to provide reports at the end of the study." The final report provides closure and documentation that the study was conducted ethically and in compliance with regulatory standards. Other documents listed in the options (monitoring reports, DSMB summaries, subject logs) may be retained by the sponsor or site, but they are not mandated for IRB submission.
Thus, the correct answer is A (Final Report). This ensures the IRB/IEC has an accurate record of study completion, outcome, and compliance with ethical oversight.
References:
ICH E6(R2), §4.13 (Final reporting to IRB/IEC).
21 CFR 312.66 (IRB review and reporting).

NEW QUESTION # 64
An investigator's responsibilities for conducting clinical trials include:

A. Maintaining IRB meeting minutes
B. Observing preclinical drug effects
C. Administering or overseeing investigational drug administration
D. Maintaining financial documentation for study staff

Answer: C

Explanation:
* ICH E6(R2) 4.6.1:The investigator is responsible for investigational product accountability at the site.
* 21 CFR 312.61:Investigators must administer the investigational drug only to subjects under their supervision.
The IRB maintains meeting minutes (A), preclinical studies are sponsor tasks (B), and financial interest documentation (C) is covered under sponsor reporting. Thus,D is correct.
References:ICH E6(R2) §4.6.1; 21 CFR 312.61.

NEW QUESTION # 65
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 IRB/IEC
B. The sponsor
C. The clinical investigator
D. The site's legal counsel

Answer: A

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 # 66
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