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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 (Q122-Q127):

NEW QUESTION # 122
A sponsor's monitor is conducting a site selection visit for an interventional drug trial. In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?

A. Number of staff members
B. Available storage square footage
C. Storage cost
D. Storage facility temperature range

Answer: D

Explanation:
Drug storage conditions are essential to maintaining investigational product (IP) integrity. According to ICH:
* ICH E6(R2) 5.13.3:"The sponsor should ensure that investigational products are stored... under appropriate conditions as specified by the sponsor and in accordance with applicable regulatory requirement(s)."
* ICH E6(R2) 4.6.4:"The investigator/institution should store the investigational product(s) as specified by the sponsor (and in accordance with applicable regulatory requirement(s)), and ensure that product (s) are used only in accordance with the approved protocol." During site qualification/selection, the monitor evaluates storage conditions - particularlytemperature ranges- to ensure the site can meet the stability requirements for the IP. Factors like staff numbers, space, and cost are operational considerations but not regulatory determinants of site qualification.
Thus, the correct answer isC (Storage facility temperature range). This ensures compliance with sponsor specifications, product stability, and ultimately subject safety.
References:
ICH E6(R2), §5.13.3 (Product storage requirements).
ICH E6(R2), §4.6.4 (Investigator product storage responsibilities).

NEW QUESTION # 123
When can an IRB/IEC review a study using expedited review?

A. For initial review of a study using specimens with identifiers
B. For protocol changes involving more than minimal risk
C. For initial review of Phase III IND protocol
D. For minor changes to previously approved protocol

Answer: D

Explanation:
* 21 CFR 56.110(b):IRBs may use expedited review forminor changesin previously approved research.
* Expedited review cannot be used for initial reviews of high-risk protocols or major modifications.
Correct answer isD.
References:21 CFR 56.110(b).

NEW QUESTION # 124
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 site's legal counsel
C. The sponsor
D. The clinical investigator

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 # 125
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

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

Answer: A

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 isB (Ensuring FDA and investigators are promptly informed).
References:
21 CFR 312.55(b) (Sponsor notification requirements).

NEW QUESTION # 126
In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study. Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?

A. The delegation of duties log
B. The site's accreditation certificate
C. The site's SOPs
D. The IRB/IEC trial approval documentation

Answer: D

Explanation:
* 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."
* Sponsors must confirm IRB approval before authorizing initiation.
References:ICH E6(R2), §4.4.1.

NEW QUESTION # 127
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