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100% Pass-Rate CCRP Sample Questions Pdf & Useful Exam Dumps CCRP Collection

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100% Pass-Rate CCRP Sample Questions Pdf & Useful Exam Dumps CCRP Collection

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SOCRA CCRP Exam Syllabus Topics:
TopicDetails
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.

Certified Clinical Research Professional (CCRP) sure pass dumps & CCRP actual training pdfThey work together and analyze the examination content to compile most probable CCRP real dumps in three formats. These SOCRA Certification Exams questions will surely appear in the next SOCRA CCRP exam. Memorizing these SOCRA CCRP Valid Dumps will help you easily attempt the CCRP exam within the allocated time. Thousands of aspirants have passed their CCRP exam, and they all got help from our SOCRA CCRP updated exam dumps.
SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q73-Q78):NEW QUESTION # 73
A study coordinator is developing an informed consent form for the first time. As per the CFR and ICH GCP Guideline, which of the following elements must be included?
  • A. A statement confirming that the subject has received a copy of the signed consent document
  • B. A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial
  • C. An explanation of the person to contact at the sponsor for further information regarding research subjects' rights
  • D. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
Answer: D
Explanation:
Theinformed consent processmust include all basic elements listed in federal regulations.
* 21 CFR 50.25(a)(4):Requires "a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject."
* ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.
This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.
Incorrect options:
* A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.
* B: Financial disclosures may be required for IRB review, not subject-facing.
* C: Subjects do receive a copy, but it is not a required consentelementin regulations.
Correct answer.
References:
21 CFR 50.25(a)(4).
ICH E6(R2), §4.8.10(c).

NEW QUESTION # 74
In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?
  • A. Investigator
  • B. Institution
  • C. Regulatory authority
  • D. Sponsor
Answer: D
Explanation:
* ICH E6(R2) 5.5.3:Sponsors are responsible for validating computerized systems used in trials.
Investigators ensure proper data entry, but system compliance lies with sponsor.
References:ICH E6(R2), §5.5.3.

NEW QUESTION # 75
A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit. According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?
  • A. Within 10 working days
  • B. Immediately
  • C. Within 15 working days
  • D. Within 7 working days
Answer: B
Explanation:
ICH requiresimmediatereporting of all SAEs to the sponsor (except those protocol-identified as not requiring immediate reporting). Exact extract:
* ICH E6(R2) 4.11.1: "The investigatorshould report all serious adverse events immediately to the sponsorexcept for those SAEs that the protocol... identifies as not needing immediate reporting." Therefore, "Immediately" (A) is correct. The other timeframes are not aligned with ICH GCP for initial SAE notification from investigator to sponsor.
References:
ICH E6(R2) Good Clinical Practice, §4.11.1 (Safety reporting by investigators).===========

NEW QUESTION # 76
After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?
  • A. The study coordinator
  • B. The IRB/IEC
  • C. The sponsor
  • D. The investigator
Answer: C
Explanation:
Monitoring reports are sponsor-controlled documents.
* ICH E6(R2) 5.18.6:"The monitor should submit a written report to the sponsor after each trial-site visit... The sponsor should review and follow up on the monitoring report."
* ICH E6(R2) 8.1 & 8.2.22:Monitoring visit reports are essential documents maintained by the sponsor.
Investigators are not required to retain monitoring reports; they maintain site regulatory binders and subject records. The study coordinator assists investigators, but does not hold sponsor-owned reports. IRBs also do not receive sponsor monitoring reports.
Thus, the correct answer isB (The sponsor).
References:
ICH E6(R2), §5.18.6 (Monitoring reports).
ICH E6(R2), §8.2.22 (Essential documents: monitoring visit reports).

NEW QUESTION # 77
An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC. In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?
  • A. The sponsor and the IRB/IEC
  • B. The investigator/institution and the delegated site staff
  • C. The sponsor and the FDA
  • D. The investigator/institution and the sponsor
Answer: D
Explanation:
Theprotocol signature pagedocuments agreement between the sponsor and the investigator/institution to conduct the trial in compliance with ICH GCP, the protocol, and regulatory standards.
* ICH E6(R2) 8.2.2 (Signed protocol and amendments):Requires "the sponsor and investigator
/institution to sign the protocol and amendments, confirming agreement."
* ICH E6(R2) 4.5.1:"The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, approved by the regulatory authority(ies) and by the IRB/IEC." The sponsor-investigator signatures ensure shared accountability for subject protection, data integrity, and adherence to trial methodology. Neither delegated staff (B) nor IRB/IEC (C) nor FDA (D) sign protocols.
These bodies approve or oversee, but do not formally enter into execution of the protocol.
Thus, the correct answer isA (The investigator/institution and the sponsor).
References:
ICH E6(R2), §8.2.2 (Signed protocol and amendments).
ICH E6(R2), §4.5.1 (Investigator compliance with protocol).

NEW QUESTION # 78
......
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