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[General] [New Launch] SOCRA CCRP Dumps (Practice Test) with Newly CCRP Exam

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【General】 [New Launch] SOCRA CCRP Dumps (Practice Test) with Newly CCRP Exam

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q47-Q52):NEW QUESTION # 47
Which of the following statements about the investigator's brochure is correct?
  • A. It includes financial disclosure information from investigators
  • B. It provides documents that permit the evaluation of the conduct of the study and the quality of the data
  • C. It consists of the instructions for the investigator to conduct the study
  • D. It contains a summary of the pharmacological and toxicological effects of the drug in animals, and to the extent known, in humans
Answer: D
Explanation:
TheInvestigator's Brochure (IB)is a critical regulatory document designed to provide investigators with comprehensive knowledge about an investigational product.
* ICH E6(R2) 7.1efines the IB as "a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects."
* ICH E6(R2) 7.2.2:Specifies the IB should contain asummary of pharmacological, toxicological, pharmacokinetic, and metabolic studies in animals, as well as results from previous human experience.
* The purpose is to allow investigators to makerisk-benefit assessments, support protocol design, and ensure subject safety.
Incorrect options:
* A (instructions to conduct study) describes theprotocol, not the IB.
* C (financial disclosures) are required under21 CFR 54, not part of the IB.
* D refers totrial master file/essential documents, not the IB.
Therefore, the IB's defining function is to provide ascientific summary of preclinical and clinical data supporting safe human use.
References:
ICH E6(R2), §7.1, §7.2.2.

NEW QUESTION # 48
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. A copy of medical license
  • B. A curriculum vitae
  • C. A letter of recommendation from a fellow physician
  • D. Proof of citizenship
Answer: B
Explanation:
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).

NEW QUESTION # 49
Which of the following is considered a source document?
  • A. The protocol
  • B. The subject instruction sheet
  • C. Pharmacy dispensing records
  • D. Standard operating procedures (SOPs)
Answer: C
Explanation:
Source documentsare the original records where trial data are first recorded, from which Case Report Form (CRF) entries are verified.
* ICH E6(R2) 1.52efines 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).

NEW QUESTION # 50
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 investigator
  • B. The study coordinator
  • C. The sponsor
  • D. The IRB/IEC
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 # 51
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. Document and explain the deviation from the protocol
  • B. Assign another investigator to perform sample collections until an internal investigation is completed
  • C. Suspend all trial-related activities until the events of the deviation have been mitigated
  • D. Immediately report the observation to the regulatory authority
Answer: A
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 # 52
......
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