An SAE is defined as any untoward medical occurrence that meets any of the criteria mentioned in the options. It includes events that result in death, are life-threatening, require hospitalization (either inpatient or prolongation of existing hospitalization), or result in persistent or significant ...
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...
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 ...
FAS(Fullanalysisset)全分析集 PPS(PerprotocolSet)符合方案集 SS(Safetyset)安全性分析集 NMPA(NationalMedicalProductsAdministration)国家药品监督管理局 三、常见术语和定义 临床试验:是指在符合条件的医疗器械临床试验机构中,对拟申请注册的医疗器械(含体外诊断试剂)在正常使用条件下的安全性和有效性进行确认的过程。
Full-Service Solution: We manage and execute full-service clinical trials across major therapeutic areas within medical device, diagnostics, drug, and biologic. Functional Service Provisi... Product BDD Scintigraphy Gamma scintigraphy is a powerful and versatile technology used to investigate the in...
Fullanalysisset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 Genericdrug通用名药 Globalassessmentvariable全局评价变量 GLU血糖 Goodclinicalpractice,GCP药物临床试验质量管理规范 Goodmanufacturepractice,药品生产质量管理规范 GMP Goodnon-clinical药物非临床研究质量管理规 ...
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。
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...
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,...
When an investigator initiates and takes full responsibility for a trial, the investigator then also assumes the role of the sponsor. standard operating procedures (SOP) Standard, detailed, written instructions for the management of clinical trials. They provide a general framework enabling the ...