缩略语英文全称中文全称ADEAdverse Drug Event药物不良事件ADRAdverse Drug Reaction药物不良反应AEAdverse Event不良事件AIAssistant Investigator助理研究者BMIBody Mass Index体质指数CICo-investigator合作研究者COICoordinating Investigator协调研究者CRCClinicalResearchCoordinator临床研究协调者CRFCase Report Form病历报告表CRO...
Fixed-dose procedure 固定剂量法 Forced titration 强制滴定 Full analysis set 全分析集 GC-FTIR 气相色谱一傅利叶红外联用 GC-MS 气相色谱一质谱联用 Generic drug 通用名药 Global assessment variable 全局评价变量 GLU 血糖 Good clinical practice, GCP 药物临床试验质量治理标准 Good manufacture practice, GMP...
Reviewing the full study plan (see section IRB responsibilities for the documents which comprise a full protocol) for a research study to ensure that the research meets the criteria specified in 45 CFR 46.111.(See summarized Criteria for IRB approval of research.). 审查研究的完整研究计划(请参阅...
lControl of study medications/devices: the product being studied must be managed so that study subjects ultimately receive a safe product and full accountability can be documented; 研究用药物/器械的管理:研究用品必须被管理,以便受试者最终使用的是安全的产品,研究用品使用必须记录。 lIntegrity of data: ...
Medical writingEthics in human researchToday, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with tragedies ...
病例报告表(CRF):英文全称Case Report Form,病例报告表, 是在临床试验中用以记录每一名受试者在试验过程中的症状、体征或实验室检查数据的文件。 不良事件(AE)英文全称Adverse Event, AE, 指病人或临床试验受试者接受一种药品后出现...
Ⅲ、For controlled drugs, a copy of the research project's Drug Enforcement Administration (DEA) registration form. 1、使用药物的鉴定;给药方法的说明,包括剂量。 2、给药人员被授权这样做的证据。 3、管制药品,需提供研究项目的禁毒管理局(DEA)登记表复印件。
Full analysis set 全分析集 GC-FTIR 气相色谱-傅利叶红外联用 GC-MS 气相色谱-质谱联用 Generic drug 通用名药 Global assessment variable 全局评价变量 GLU 血糖 Good clinical practice, GCP 药物临床试验质量管理规范 Good manufacture practice, GMP 药品生产质量管理规范 Good non-clinical laboratory practice,...
TheGCPcenterimplementsthemanagementoftheIITtrialswiththesamequalityastheINDvariousfunctionscoveringmultiplerolessuchasmedicalcareandmanagement,coveringthe wholeprocessfromtrialconsultation,screeningexamination,enrollmenttreatment,adversereaction trials.Wearecommittedtoprovidingresearchersafullrangeofservices,includingresearch meth...
Full analysis set 全分析集 GC-FTIR 气相色谱-傅利叶红外联用 GC-MS 气相色谱-质谱联用 Generic drug 通用名药 Global assessment variable 全局评价变量 GLU 血糖 Good clinical practice, GCP 药物临床试验质量管理规范 Good manufacture practice, GMP 药品生产质量管理规范 Good non-clinical laboratory practice,...