ACRP ACRP-CP 考試概覽:

認證廠商:	ACRP (臨床研究專業人員協會)
考試名稱:	ACRP 認證專業人員 (ACRP-CP) 認證考試
考試代碼:	ACRP-CP
支援語言:	English
實際考試題數:	約 130 題
考試形式:	電腦化測驗, 單選題
相關認證:	ACRP 認證臨床研究助理 (CCRA) ACRP 認證臨床研究協調員 (CCRC)
考試時間:	180 分鐘
推薦課程:	ACRP 官方培訓與教育
考試報名:	Pearson VUE 註冊入口網站 ACRP 認證頁面
範例考題:	ACRP ACRP-CP 範例考題
考試方式:	透過授權的測試提供商在考試中心進行電腦化測驗和/或進行遠端監考
必備條件:	通常需要具備臨床研究的專業經驗（通常約 2-3 年以上，具體取決於資格途徑）；資格要求因 ACRP 官方認證政策中的不同途徑而異。
官方大綱網址:	https://www.acrpnet.org/

ACRP ACRP-CP 考試大綱主題:

章節	目標
主題 1: 法規遵循	- 稽核與檢查準備 - 法規文件與申報
主題 2: 臨床研究基礎	- 臨床試驗中的倫理行為 - 優良臨床試驗規範 (GCP) 原則
主題 3: 數據與品質管理	- 品質保證與品質管制 - 臨床數據管理原則
主題 4: 研究運作	- 研究規劃與啟動 - 研究執行與監督
主題 5: 受試者安全與保護	- 安全報告與不良事件 - 知情同意程序

最新的 ACRP Certified Professional ACRP-CP 免費考試真題：

問題 #1

Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?

A. How does the risk of developing cancer compare to the anticipated side effects from the drug?
B. How willing are current patients to participate in a trial with potentially serious side effects?
C. How likely are patients at high risk of cancer going to develop cancer during the study?
D. How effective is the drug at treating patients that have been previously diagnosed with cancer?

問題 #2

A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A. Sponsor
B. Monitor
C. Data Manager
D. QA Department

問題 #3

A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A. Package insert
B. Protocol
C. IB
D. ICF

問題 #4

A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A. CRF.
B. Source document.
C. Worksheet.
D. PRO.

問題 #5

A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A. A signed clinical trial agreement between the site and sponsor is in place.
B. The CRA has performed source document review and verification at the site.
C. The DSMB meets and the first DSMB meeting report has been issued.
D. The site receives approval from the medical monitor to begin enrolling.

問題與答案：

問題 #1
答案： A

問題 #2
答案： B

問題 #3
答案： D

問題 #4
答案： A

問題 #5
答案： A