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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