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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.

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.

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q78-Q83):

NEW QUESTION # 78
A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?

A. $10,000
B. $5,000
C. Any amount
D. >$25,000

Answer: A

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 # 79
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 # 80
A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities. According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?

A. The external source
B. The sponsor
C. The investigator/institution
D. The IRB/IEC

Answer: C

Explanation:
The investigator/institution bears responsibility for site conduct, oversight of delegated tasks, and ensuring qualified, trained staff-regardless of employment source. Exact extracts:
* ICH E6(R2) 4.1.1: "The investigator should bequalified... and haveadequate resourcesto properly conduct the trial."
* ICH E6(R2) 4.1.5: "The investigatorshould ensure that all persons assistingwith the trial are adequately informedabout the protocol, the investigational product(s), and their trial-related duties and functions."
* ICH E6(R2) 4.2.5: "The investigatormay delegate... butretains responsibilityfor the conduct of the trial at the site."Therefore, the investigator/institution (B) must implement procedures and oversight to maintain integrity of trial duties.
References:
ICH E6(R2) Good Clinical Practice, §4.1.1; §4.1.5; §4.2.5 (Investigator responsibilities; delegation and oversight).===========

NEW QUESTION # 81
An unconscious patient experiencing life-threatening cardiac arrhythmias has been admitted to an emergency room. No FDA-approved treatment is available, and no legal representative is present. The clinical investigator determined that the use of an investigational antiarrhythmic drug is required. In accordance with the CFR, who must certify the investigator's determination?

A. An independent physician
B. The sponsor's study monitor
C. The sponsor's medical monitor
D. A sub-investigator

Answer: A

Explanation:
This scenario falls underemergency use of investigational drugs without informed consent.
* 21 CFR 50.23(a):Allows waiver of informed consent if subject faces a life-threatening condition, available treatments are unproven, and immediate use is required.
* 21 CFR 50.23(a)(3):Requires that "the determination... be reviewed and concurred with by a physician who is not otherwise participating in the clinical investigation." Thus, anindependent physician(not part of the trial team) must certify the necessity of emergency investigational use.
Sponsors and monitors (C, D) are not authorized by regulation to make such determinations. Sub-investigators (A) lack independence and would be conflicted.
Correct answer:B (Independent physician).
References:
21 CFR 50.23(a)(3).

NEW QUESTION # 82
An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?

A. Report to FDA
B. Report to sponsor
C. None
D. Report to OHRP

Answer: C

Explanation:
* 21 CFR 54.4(b):Requires disclosureduring the study and for 1 year after completion.
* After three years, no disclosure is required.
References:21 CFR 54.4(b).

NEW QUESTION # 83
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Reliable and Guarantee Refund of SOCRA CCRP Exam Questions

SOCRA CCRP Exam Syllabus Topics:

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q78-Q83):

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