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SOCRA CCRP Exam Topic | CCRP Free Vce Dumps

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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 CCRP Exam Topic <<

SOCRA CCRP Dumps - Try Free CCRP Exam Questions and Answer

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q81-Q86):

NEW QUESTION # 81
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?

A. The sponsor failed to submit an accurate annual report of the study to the FDA
B. An investigator failed to submit safety reports to the FDA
C. The FDA issued a clinical hold, and 30 days have elapsed
D. The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study

Answer: C

Explanation:
The FDA has authority to imposeclinical holds and terminationson IND studies when subject safety is at risk.
* 21 CFR 312.44(b)(1):"The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury."
* 21 CFR 312.42(e):"If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND." Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination.
IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).
Thus, the correct answer isD (The FDA issued a clinical hold, and 30 days have elapsed).
References:
21 CFR 312.44(b)(1) (Termination of an IND).
21 CFR 312.42(e) (Clinical hold procedures).

NEW QUESTION # 82
In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?

A. In a timely manner before, during, and after the study
B. Once a year until study close-out
C. At least weekly
D. Every 4-6 weeks until study close-out

Answer: A

Explanation:
Monitoring ensures trial integrity and subject safety.
* ICH E6(R2) 5.18.3:"The sponsor should ensure that the trials are adequately monitored. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial."
* Monitoring must occurbefore (initiation visit), during (periodic), and after (closeout).
It is not limited to fixed weekly or monthly intervals (A, B) and not as infrequent as yearly (D). Instead, it is risk-adapted and flexible, but must cover all phases of the study.
Correct answer:C (Timely manner before, during, and after).
References:
ICH E6(R2), §5.18.3.

NEW QUESTION # 83
In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

A. Submitting progress reports to the reviewing IRB/IEC
B. Ensuring that the FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
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: B

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 # 84
Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?

A. The act of reviewing and approving the investigational protocol and informed consent document
B. The planned and systematic actions established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements
C. An official review by a regulatory authority of documents, facilities, records, and any other resources that are deemed to be related to the trial
D. The systematic plan to review, approve, and monitor biomedical and behavioral research involving human subjects

Answer: B

Explanation:
Quality assurance (QA)is proactive and systematic, designed to prevent errors and ensure compliance.
* ICH E6(R2) 1.46:Defines QA as "all those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and applicable regulatory requirements." Option A describes IRB responsibilities, Option C describesaudit, and Option D describes protocol approval processes. OnlyBaccurately matches the ICH definition of QA. QA is distinct fromquality control (QC), which is operational and focused on detection of issues during conduct.
Thus, the correct answer isB.
References:
ICH E6(R2), §1.46 (Definition of Quality Assurance).

NEW QUESTION # 85
A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?

A. Lab draw requirements
B. Dispensing instructions
C. Results of recent nude mouse study
D. Schedule of events

Answer: C

Explanation:
TheInvestigator's Brochure (IB)compilesclinical and nonclinical dataon an investigational product relevant to human study.
* ICH E6(R2) 7.2.3:The IB should summarizenonclinical pharmacology, toxicology, pharmacokinetics, and efficacy data, including results of animal studies.
* ICH E6(R2) 7.2.4:It should also includeavailable clinical trial dataand safety experience.
The "results of recent nude mouse study" (B) are nonclinical data, which appropriately belong in the IB. Lab draw requirements (A), dispensing instructions (C), and schedules of events (D) are operational/procedural and are found in theprotocol, not the IB.
Thus, the correct answer isB (Results of recent nude mouse study).
References:
ICH E6(R2), §7.2.3-7.2.4 (Contents of Investigator's Brochure).

NEW QUESTION # 86
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