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Dana Wei ICON Sr. CRA. * Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans,

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Presentation on theme: "Dana Wei ICON Sr. CRA. * Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans,"— Presentation transcript:

1 Dana Wei ICON Sr. CRA

2 * Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue.

3 * A clinical trial is one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. https://www.youtube.com/watch?v=heLyb9FiqQM

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5 Picture courtesy of http://www.clinical-trials-info.com/

6 * 我會半開玩笑的說:「我就好像古早時候啤酒廠的品 質監測工 (monitor) ,坐在啤酒生產線旁邊一整天 (Site) ,眼睛盯著輸送帶上的啤酒瓶看 (SDV) ,看到啤 酒瓶裡面出現雜質要挑出來 (Query) ,然後老闆不信 任我,所以又顧了一個監工看著我有沒有好好看酒瓶。 (Auditor) 」 摘自阿唐的謬思 http://mingtangyang.blogspot.tw/2010/12/clinical-research-associate-cra.html

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8 (1)Preparation before study initiated Site selection, Submission, Contract negotiation… (2)Study execution Site initiation, Recruitment, Amendment, Data clean…. (3) Study finish Site close out, study final report, inspection

9 CRA CRM (Clinical Research Manager) CRA Trainer Auditor Medical Affairs Medical Science Liaison Product Manager

10 Wei.dana@gmail.com

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