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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 (Q73-Q78):

NEW QUESTION # 73
A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:

A. Phase I
B. Phase II
C. Phase III
D. Phase IV

Answer: B

Explanation:
Phase classification is based on study objectives, not just subject numbers.
* Phase I:Focuses on safety, pharmacokinetics, dose-ranging, usually in healthy volunteers or small patient groups.
* Phase II:Evaluateseffectiveness in patients with the conditionand monitors common short-term side effects.
* Phase III:Confirms effectiveness in larger populations, compares to standard therapy, gathers more safety data.
* Phase IV:Post-marketing studies exploring new indications, long-term safety, or special populations.
The given study aims toevaluate effectiveness and common short-term side effectsin 30 arthritis patients, which clearly aligns withPhase IIobjectives. It is not exploratory safety (Phase I), not confirmatory comparative (Phase III), nor post-marketing (Phase IV).
Thus, the correct answer isB (Phase II).
References:
FDA Guidance: The IND Application - §312.21 (Phases of an investigation).
ICH E8(R1), General Considerations for Clinical Studies.

NEW QUESTION # 74
The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?

A. 5 years
B. 2 years
C. 3 years
D. 15 years

Answer: B

Explanation:
Retention of essential documents ensures accountability and inspection readiness.
* ICH E6(R2) 5.5.12 & 8.1:Sponsors should retain essential documents "until at least2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applicationsor at least 2 years after formal discontinuation of clinical development of the investigational product." This standard balances subject protection with practical recordkeeping. Longer durations (B-D) may apply under institutional or national rules, but ICH establishes2 years minimum.
Correct answer:A (2 years).
References:
ICH E6(R2), §5.5.12, §8.1.

NEW QUESTION # 75
Which of the following elements should NOT influence the investigator's ability to obtain endpoint data?

A. Complexity of CRFs
B. Complexity of study
C. Length of study follow-up
D. Participant compliance

Answer: A

Explanation:
* Endpoint data collection is based onprotocol designand subject compliance, not CRF formatting.
* ICH E6(R2) 4.9.0:Investigator responsible for data accuracy regardless of CRF complexity.
References:ICH E6(R2), §4.9.0.

NEW QUESTION # 76
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

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 # 77
Which of the following is an example of an additional protection required when conducting research on children?

A. The investigator must obtain age-appropriate assent as determined by the IRB/IEC
B. Parents must be present during all procedures
C. There must be an impartial advocate present during the consent process
D. The study must be approved by a central pediatric IRB

Answer: A

Explanation:
Children are a vulnerable population. U.S. regulations require IRB/IEC judgment about when and howassent is obtained, in addition to parental permission. Exact extracts:
* 45 CFR 46.408(a): "The IRB shall determine...whether and to what extent children are capable of providing assent."
* ICH E6(R2) 4.8.12: "Where a subject is unable to give consent personally,assent should be obtained when appropriate, in accordance with applicable regulatory requirement(s)."Thus, the additional protection is IRB-determined, age-appropriate assent (B). Options A, C, and D are not universal requirements for all pediatric research.
References:
ICH E6(R2) Good Clinical Practice, §4.8.12 (Informed consent/assent).
45 CFR 46 Subpart D-Additional Protections for Children, §46.408(a).===========

NEW QUESTION # 78
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