最新的SOCRA Certified Clinical Research Professional (CCRP) - CCRP免費考試真題
問題1
A clinical investigator wants to publish a subject's unique results. The consent form did not mention publication. What is required?
正確答案: D
說明：（僅 VCESoft 成員可見）
問題2
A subject enrolled in a drug clinical trial has withdrawn from the study. In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?
正確答案: C
說明：（僅 VCESoft 成員可見）
問題3
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?
正確答案: C
說明：（僅 VCESoft 成員可見）
問題4
Which of the following is one of the responsibilities of an investigator?
正確答案: B
說明：（僅 VCESoft 成員可見）
問題5
The sponsor discontinued the clinical development of an investigational product. In accordance with the ICH GCP Guidance, at least how long should the sponsor maintain all sponsor-specific essential documents?
正確答案: B
說明：（僅 VCESoft 成員可見）
問題6
A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:
正確答案: C
說明：（僅 VCESoft 成員可見）
