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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.

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 CCRP Exam Questions Vce, CCRP Reliable Exam Price

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q67-Q72):

NEW QUESTION # 67
An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?

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

Answer: D

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 # 68
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?

A. It does not identify some of the applicable mandated basic elements
B. It identifies all of the applicable mandated basic elements
C. It is signed and dated by the subject's legally authorized representative
D. It is signed and dated by the IRB/IEC chair

Answer: B

Explanation:
The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
* 21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
* ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D).
Options A and B confuse who signs-subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer:D.
References:
21 CFR 50.25(a).
ICH E6(R2), §4.8.10.

NEW QUESTION # 69
In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?

A. The reviewing IRB/IEC
B. A data safety monitoring board
C. The medical monitor
D. The clinical investigator

Answer: A

Explanation:
Minimal risk determination is a regulatory function of the IRB/IEC.
* 45 CFR 46.102(j):Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.
* 45 CFR 46.109(a):The IRB has authority to approve, require modifications, or disapprove research, including assessment ofrisk level.
* Investigators may propose a study as minimal risk, but only theIRB/IEC can formally classify it.
This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.
References:45 CFR 46.102(j), 46.109(a).

NEW QUESTION # 70
An investigator reports a serious adverse event suspected to be drug-related. By CFR, the sponsor must notify FDA no later than:

A. 15 days
B. 10 days
C. 7 days
D. 1 day

Answer: C

Explanation:
* 21 CFR 312.32(c)(2):Life-threatening or fatal unexpected adverse events must be reported within7 calendar days.Other serious unexpected events are reported within 15 days.
References:21 CFR 312.32(c)(2).

NEW QUESTION # 71
According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?

A. The subject or else the subject's legally authorized representative
B. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee
C. The subject or else the subject's legally authorized representative; the witness
D. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness

Answer: C

Explanation:
Theshort form consent processis permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.
* 21 CFR 50.27(b)(2):Requires the short form to be signed by the subject (or legally authorized representative)and a witness.
* The witness ensures that oral consent was properly conveyed and understood.
* The person obtaining consent must sign aseparate written summary, but not the short form itself.
Thus, the accurate answer isA: subject (or LAR) + witness.
References:
21 CFR 50.27(b)(2).

NEW QUESTION # 72
......

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Valid CCRP pdf vce & SOCRA CCRP test answers & CCRP troytec exams

SOCRA CCRP Exam Syllabus Topics:

SOCRA CCRP Exam Questions Vce, CCRP Reliable Exam Price

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q67-Q72):

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