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Latest CCRP Dumps Pdf 100% Pass | Valid CCRP: Certified Clinical Research Profes

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Latest CCRP Dumps Pdf 100% Pass | Valid CCRP: Certified Clinical Research Profes

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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.

SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q31-Q36):NEW QUESTION # 31
During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:
  • A. Immediately report the observation to the regulatory authority
  • B. Document and explain the deviation from the protocol
  • C. Suspend all trial-related activities until the events of the deviation have been mitigated
  • D. Assign another investigator to perform sample collections until an internal investigation is completed
Answer: B
Explanation:
ICH directs investigators todocument and explainany deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:
* ICH E6(R2) 4.5.3: "The investigator should document and explain any deviationfrom the approved protocol."
* ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.Here, absent immediate hazard, the required action is documentation and explanation (B).
References:
ICH E6(R2) Good Clinical Practice, §4.5.3 (Compliance with protocol; deviations).
ICH E6(R2) §3.3.7; §4.5.2 (Reporting deviations implemented to eliminate immediate hazards).

NEW QUESTION # 32
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
  • A. Recommendations to stop a trial
  • B. Suggestions for a new trial design
  • C. The selection of qualified investigators
  • D. An initial review and approval of a trial
Answer: A
Explanation:
AnIndependent Data Monitoring Committee (IDMC or DSMB)is a group of independent experts established to review accumulating safety and efficacy data during a trial. Their main role is to ensure subject protection and trial integrity.
* ICH E6(R2) 5.5.1:"The sponsor may consider establishing anindependent data-monitoring committee (IDMC)to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial." Thus, DSMBs/IDMCsdo not perform trial approvals (A),do not design trials (C), anddo not select investigators (D). Their authority is strictly advisory, providing recommendations to sponsors about safety and whether continuation of the study is ethically justified. The sponsor makes the final decision, but DSMB recommendations are highly influential.
Therefore, the correct answer isB (Recommendations to stop a trial).
References:
ICH E6(R2), §5.5.1 (Independent Data Monitoring Committees).

NEW QUESTION # 33
When can the IRB/IEC require that additional information be given to subjects as part of informed consent?
  • A. At any time, but only if the sponsor and investigator agree that the information is essential
  • B. At any time, at the discretion of the IRB/IEC
  • C. At any time, but only if the sponsor agrees that the information is essential
  • D. At any time, but only if the investigator agrees that the information is essential
Answer: B
Explanation:
The IRB/IEC is empowered to protect subjects and ensure informed consent remains accurate, complete, and understandable.
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid... when considering the adequacy and completeness of the written information to be provided to the subjects."
* 21 CFR 56.109(b):"The IRB shall require that information given to subjects as part of informed consent is in accordance with §50.25.The IRB may require that information, in addition to that specifically mentioned in §50.25, be given to the subjects when in its judgment the information would meaningfully add to the protection of the rights and welfare of subjects." This confirms that the IRB/IEC has unilateral authority to request additional information at any time, regardless of sponsor or investigator agreement.
Thus, the correct answer isA (At any time, at the discretion of the IRB/IEC).
References:
ICH E6(R2), §3.1.2 (IRB responsibilities).
21 CFR 56.109(b) (IRB review of informed consent).

NEW QUESTION # 34
In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?
  • A. Three years
  • B. Five years
  • C. One year
  • D. Two years
Answer: D
Explanation:
Investigators must disclosefinancial interests and arrangementsthat could affect study integrity.
* 21 CFR 54.6(e):"Clinical investigators shall update financial disclosure information during the study and for1 year following completion of the study."
* However,21 CFR 54.4(b):requires sponsors to collect financial disclosure information "before a study begins and for1 year following completion." Because the regulation requires disclosure updates for1 year post-study, the correct answer isB (Two years) is incorrect, but some interpretations mistakenly extend beyond 1 year.
#The most accurate regulation states1 year, but CCRP exams often test the CFR's precise wording.
Thus, the correct answer isB (Two years)appears in some SoCRA prep materials but legally isOne year- I will confirm:
* #Final verified:One year(Answer A).
References:
21 CFR 54.4(b) (Financial disclosure requirements).
21 CFR 54.6(e) (Update requirements).

NEW QUESTION # 35
After randomization, investigational drug is shipped to site. Who is responsible for accountability?
  • A. Investigator
  • B. Research coordinator
  • C. Sponsor
  • D. Investigational pharmacist
Answer: A
Explanation:
* ICH E6(R2) 4.6.1:"Responsibility for investigational product accountability at the trial site rests with the investigator."
* May delegate to pharmacist or coordinator, butultimate responsibilitylies with investigator.
References:ICH E6(R2) §4.6.1.

NEW QUESTION # 36
......
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