最新なSOCRA CCRP問題集（132題）、真実試験の問題を全部にカバー！

質問 1：
Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?
A. The FDA or another regulatory authority
B. The Department of Health and Human Services
C. The IRB/IEC
D. No approvals are necessary if no pharmaceutical drugs are involved
正解：C
解説: (Pass4Test メンバーにのみ表示されます)

質問 2：
A research protocol requires patients to complete a patient reported outcome questionnaire in the sponsor's electronic data capture (EDC) system. What is the source data?
A. A printout of the electronic medical record
B. The electronic medical record
C. The EDC record
D. A printout of the EDC record
正解：C
解説: (Pass4Test メンバーにのみ表示されます)

質問 3：
The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?
A. The sponsor failed to submit an accurate annual report of the study to the FDA
B. The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study
C. The FDA issued a clinical hold, and 30 days have elapsed
D. An investigator failed to submit safety reports to the FDA
正解：C
解説: (Pass4Test メンバーにのみ表示されます)

質問 4：
Which of the following adverse events occurring during a study of an investigational new drug would require the sponsor to notify the FDA as soon as possible but in no case later than seven calendar days after the initial receipt of the information?
A. Death due to disease progression, mentioned in the investigator's brochure
B. Aplastic anemia requiring hospitalization, mentioned in the investigator's brochure
C. Death as a result of arrhythmias (irregular heart rhythm), not mentioned in the investigator's brochure and thought to be related to the use of the drug
D. An infection not related to the investigational drug requiring hospitalization for antibiotic therapy
正解：C
解説: (Pass4Test メンバーにのみ表示されます)

質問 5：
Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
A. India
B. China
C. Switzerland
D. Brazil
正解：A
解説: (Pass4Test メンバーにのみ表示されます)

質問 6：
A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind. Where can the sub-investigator find a description of the unblinding procedure?
A. The informed consent form
B. The study protocol
C. The case report form
D. The Investigator's Brochure
正解：B
解説: (Pass4Test メンバーにのみ表示されます)

質問 7：
A study will enroll 420 subjects over 3.5 years. What is expected average monthly accrual?
A. 9
B. 11
C. 19
D. 10
正解：B
解説: (Pass4Test メンバーにのみ表示されます)

質問 8：
Which of the following is considered a source document?
A. Pharmacy dispensing records
B. The subject instruction sheet
C. Standard operating procedures (SOPs)
D. The protocol
正解：A
解説: (Pass4Test メンバーにのみ表示されます)