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CCRP PDF題庫 & CCRP認證題庫
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從Google Drive中免費下載最新的PDFExamDumps CCRP PDF版考試題庫：https://drive.google.com/open?id=1mWJTUr-sm9hbweUPBBXc6Bt-fENwW5II
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最新的 Clinical Research Professional CCRP 免費考試真題 (Q27-Q32):問題 #27
Which of the following statements about the investigator's brochure is correct?
- A. It provides documents that permit the evaluation of the conduct of the study and the quality of the data
- B. It contains a summary of the pharmacological and toxicological effects of the drug in animals, and to the extent known, in humans
- C. It includes financial disclosure information from investigators
- D. It consists of the instructions for the investigator to conduct the study
答案：B
解題說明：
TheInvestigator's Brochure (IB)is a critical regulatory document designed to provide investigators with comprehensive knowledge about an investigational product.
* ICH E6(R2) 7.1 efines 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.
問題 #28
A monitor is conducting a site closeout visit. The study site kept electronic medical records and source documents in a system verified to be 21 CFR Part 11 compliant. The monitor reviewed all electronic documents by logging into the system with a unique login ID and password. In addition to the essential document file, which of the following sets of documents should be provided to the monitor during the study closeout visit?
- A. Informed consent documents and investigational product documentation
- B. A copy of the final report for the IRB and investigational product shipment records
- C. Informed consent documents and printouts of electronic source documents
- D. Printouts of electronic source documents and the remaining investigational product
答案：A
解題說明：
During study closeout, the monitor verifies subject protection, protocol compliance, and investigational product accountability.
* ICH E6(R2) 8.1 & 8.4 ists essential documents to be verified at closeout, including signed informed consent forms and investigational product accountability records.
* 21 CFR Part 11:Ensures electronic records are valid, so printed copies are not always necessary unless required for auditing.
Thus, the critical items for monitor review at closeout areinformed consent forms(to confirm subject protection) andinvestigational product documentation(to confirm reconciliation and disposition).
Correct answer.
References:
ICH E6(R2), §8.1, §8.4.
問題 #29
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
- A. Read and understood the investigator's brochure
- B. Completed other relevant research projects
- C. Confirmed that the site's SOPs are in place
- D. Obtained malpractice insurance
答案：A
解題說明：
Form FDA 1572 is the "Statement of Investigator" for IND studies.
* 21 CFR 312.53(c)(1)(vi)(b):Requires investigators to "read and understand the Investigator's Brochure."
* By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.
Other options (B-D) are not part of 1572 requirements.
Correct answer:A.
References:
21 CFR 312.53(c)(1)(vi)(b).
問題 #30
According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?
- A. Staff training
- B. The protocol
- C. Adequate resources
- D. Proper equipment
答案：B
解題說明：
Before an investigator can commit to conducting a trial, they must review thestudy protocol.
* ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.
* ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator's brochure and the current approved protocol.
Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.
References:ICH E6(R2), §§4.2.3, 4.5.1.
問題 #31
For a Significant Risk device study, an investigator must report within 5 working days which event?
- A. Unanticipated adverse effect
- B. Emergency deviation
- C. Completion of investigation
- D. Withdrawal of FDA approval
答案：B
解題說明：
* 21 CFR 812.150(a)(4):Any deviation from investigational plan made to protect the life or physical well- being of a subject in an emergency must be reported to the sponsor and IRBwithin 5 working days.
* Unanticipated adverse device effects have a 10-day reporting window.
References:21 CFR 812.150(a)(4).
問題 #32
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