Translation glossary: GCP

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(protocol) amendment(方案)修订/修改
English to Chinese
a supplementary application补充申请
English to Chinese
a trial period试产期
English to Chinese
acceleration stability study test data制品加速稳定性试验资料
English to Chinese
active ingredients原料
English to Chinese
active treatment concurrent control活性治疗平行对照
English to Chinese
Active-Control Studies阳性对照试验
English to Chinese
Adverse Drug Reaction (ADR)药品不良反应
English to Chinese
Adverse Event (AE)不良事件
English to Chinese
adverse reactions不良反应
English to Chinese
audit稽查
English to Chinese
batch / lot number批号
English to Chinese
batch sample批样品
English to Chinese
biological products for prevention [vaccines]预防性生物制品
English to Chinese
biologics生物
English to Chinese
blinding / masking设盲
English to Chinese
Bridging Data Package搭桥资料集/衔接性试验数据
English to Chinese
bridging study搭桥研究 / 衔接性试验
English to Chinese
broken procedures破盲规程
English to Chinese
bulk active原料药
English to Chinese
bulk substance (including excipients)原材料(包括辅料)
English to Chinese
Case Report Form (CRF)病例报告表
English to Chinese
causality assessment因果关系评价
English to Chinese
chemical drugs化学药品
English to Chinese
China Biological Products Standards中国生物制品规程
English to Chinese
Chinese Medicine Administration Bureau中医药局
English to Chinese
classification protection system分类保护制度
English to Chinese
Clinical Data Package (CDP)临床资料集
English to Chinese
clinical demand临床需求
English to Chinese
clinical effects临床疗效
English to Chinese
clinical studies临床研究
English to Chinese
Coastal Institutes for Drug Control口岸药品检验所
English to Chinese
comparator products对照药
English to Chinese
comparison products对照品
English to Chinese
compliance依从性
English to Chinese
Compounds Insensitive to Ethic Factors种族因素不敏感性药物
English to Chinese
Compounds Sensitive to Ethic Factors种族因素敏感性药物
English to Chinese
concomitant medication合并用药
English to Chinese
confirmatory trial验证性试验
English to Chinese
Contract Research Organization (CRO)合同研究组织
English to Chinese
coordinate committee协调委员会
English to Chinese
coordinate investigator协调研究者
English to Chinese
cross-over designs交叉设计
English to Chinese
Declaration Form for Import Drug Inspection进口药品报验单
English to Chinese
direct access to source data直接查阅原始数据
English to Chinese
does comparison concurrent control剂量比较平行对照
English to Chinese
dosage form剂型
English to Chinese
dose- response量效关系
English to Chinese
double blind trial双盲试验
English to Chinese
drop out出组 / 脱落
English to Chinese
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