CRA Clinical Research Assistant,临床研究助理,是协助主要研究者按照试验方案和GCP具体实施临床试验的人员。 FDA Food and Drug Administration,美国食品药品管理局,FDA的职责是确保美国本国生产或进口的食品、化妆品、药物、生物制剂、医疗设备和放射产品的安全。它是最早以保护消费者为主要职能的机构之一。该机构与每一...
Sponsor 申办者 CRO -Contract Research Organization 合同研究组织 SMO-Site Management Organization 现场管理组织 Investigational Site 研究中心 Investigator 研究者 PI- Principal Investigator 主要研究者 SI- Sub-investigator 助理研究者 CRC- Clinical Research Coordinator 临床研究协调员 Initial Meeting 启动会 SIV-S...
Ethics in clinical re- search: Need for assessing comprehension of informed consent form? Contemporary Clinical Trials. 2011;32:169-172.Shafiq N, Malhotra S. Ethics in clinical research: need for assessing comprehension of informed consent form? Contemp Clin Trials 2011;32:169 - 72....
Report to the clinic at assigned times. Carefully weigh the possible benefits (if any) and risks of being in the study. Talk to the study staff if you want to stop being part of the research study. Report to the study staff immediately any and all problems you may be having with the ...
research organization 合同研究组织 contract/ agreement 协议/合同 control group 对照组 CD controlled documents 控制文件 coordinating committee 协调委员会 COI coordinating investigator 协调研究者 CAPA corrective action preventive action 纠正/预防措施 council for international organizations of CIOMS 国际医学科学...
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临床试验中英对照词汇表english vocabulary of clinical trials-yrn2019051011
Clinical Research Support Agreement Begin your negotiation and drafting process for an agreement between a drug manufacturer (sponsor) and an institution taking on responsibility for conducting clinical research on behalf of the sponsor with this template clinical research support agreement. Prepare an agre...
clinical research See all related content → clinical trial, formal testing of a specific treatment or other health-related intervention to determine its role in the standard care of individuals with a corresponding medical condition. Ideally, before newdrugsand other treatments, diagnostic tests, or ...
TEMPLATE ON FOLLOWING PAGE Page 1 of 8 [YOUR INSTITUTIONAL LETTER HEAD] Please do not submit consent forms on the WHO letter head [Informed Consent Form for ___] Name the group of individuals for whom this consent is written. Because research for a single project is often carried out with...