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CCRP Deutsche & CCRP Dumps Deutsch

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SOCRA CCRP Prüfungsplan:

Thema
Einzelheiten

Thema 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.

Thema 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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CCRP: Certified Clinical Research Professional (CCRP) Dumps & PassGuide CCRP Examen

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SOCRA Certified Clinical Research Professional (CCRP) CCRP Prüfungsfragen mit Lösungen (Q16-Q21):

16. Frage
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. Any amount
C. $5,000
D. >$25,000

Antwort: A

Begründung:
* 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).

17. Frage
In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB
/IEC will conduct the initial and continuing review of a study?

A. The study coordinator
B. The investigator
C. The sponsor
D. The monitor

Antwort: B

Begründung:
Theinvestigatoris directly responsible for ensuring that the IRB/IEC reviews and approves the research both initially and on a continuing basis. This responsibility is not delegable to the sponsor or study staff.
* 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 for the trial protocol, written informed consent form, consent form updates, and any other written information to be provided to subjects."
* 21 CFR 312.66:"An investigator shall assure that an IRB that complies with the requirements... will be responsible for the initial and continuing review and approval of the proposed clinical study." This means that while the sponsor submits documents to the FDA and oversees general compliance, the investigator has the obligation to obtain and maintain IRB approvalat their site. The monitor or study coordinator may assist in documentation, but legal responsibility rests with the investigator.
Thus, the correct answer isC (The investigator).
References:
ICH E6(R2), §4.4.1 (Investigator responsibility before initiation).
21 CFR 312.66 (IRB responsibility in clinical investigations).

18. Frage
Which of the following is considered a source document?

A. Standard operating procedures (SOPs)
B. The subject instruction sheet
C. Pharmacy dispensing records
D. The protocol

Antwort: C

Begründung:
Source documentsare the original records where trial data are first recorded, from which Case Report Form (CRF) entries are verified.
* ICH E6(R2) 1.52:Defines source documents as "original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, pharmacy dispensing records, recorded data from automated instruments, etc.)."
* ICH E6(R2) 8.3.13:Requires maintenance of "source documents" to verify data integrity and allow monitoring/audits.
Pharmacy dispensing records (D) fit this definition, as they show initial data on investigational product dispensing and accountability. In contrast, subject instruction sheets (A) are communication tools, SOPs (B) are procedural guides, and the protocol (C) is a governing document, none of which qualify as original data records.
Therefore, the correct answer isD (Pharmacy dispensing records).
References:
ICH E6(R2), §1.52 (Definition of source documents).
ICH E6(R2), §8.3.13 (Source documents in essential documentation).

19. Frage
A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?

A. Proof of citizenship
B. A letter of recommendation from a fellow physician
C. A curriculum vitae
D. A copy of medical license

Antwort: C

Begründung:
Investigators must provideevidence of qualificationsto conduct the study.
* ICH E6(R2) 4.1.1:"The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial."
* ICH E6(R2) 8.2.10:Essential documents include thecurriculum vitae (CV)or other documents evidencing investigator qualifications, submitted to both sponsor and IRB/IEC.
Proof of citizenship (A) and letters of recommendation (B) are irrelevant. A copy of a medical license (D) may be provided but isnot specifically requiredby ICH. The CV is the universally required document.
Thus, the correct answer isC (Curriculum vitae).
References:
ICH E6(R2), §4.1.1 (Investigator qualifications).
ICH E6(R2), §8.2.10 (Essential documents: CV).

20. Frage
In accordance with the ICH GCP Guideline, who is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms and in all required reports?

A. The clinical investigator
B. The IRB/IEC coordinator
C. The quality control specialist
D. The contract research organization monitor

Antwort: A

Begründung:
The investigator holds ultimate responsibility for all data reported.
* ICH E6(R2) 4.9.1:"The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports."
* Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.
Correct answer:A (The clinical investigator).
References:
ICH E6(R2), §4.9.1.

21. Frage
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