药品临床试验管理规范---GCP(Good Clinical Practice)
人用药物注册技术要求国际协调会---ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human U)
国际医学用语词典---MedDRA(medical dictionary for regulatory activities)
系统器官分类---SOC(System organ class)
高位组语---HLGT(High level group term)
高位语---HLT(High level term)
首选语---PT(Preferred term)
低位语---LLT(Lowest level term)
血液与淋巴系统疾病---Blood and lymphatic system disorders
心脏器官疾病---Cardiac disorders
先天性、家族性和遗传性疾病---Congenital, familial and genetic disorders
耳及迷路类疾病---Ear and labyrinth disorders
内分泌系统疾病---Endocrine disorders
眼器官疾病---Eye disorders
胃肠系统疾病---Gastrointestinal disorders
全身性疾病及给药部位各种反应---General disorders and administration site conditions
肝胆系统疾病---Hepatobiliary disorders
免疫系统疾病---Immune system disorders
感染及侵染类疾病---Infections and infestations
各类损伤、中毒及手术并发症---Injury, poisoning and procedural complications
各类检查---Investigations
代谢及营养类疾病---Metabolism and nutrition disorders
各种肌肉骨骼及结缔组织疾病---Musculoskeletal and connective tissue disorders
良性、恶性及性质不明的肿瘤(包括囊状和息肉状)---Neoplasms benign, malignant and unspecified (incl cysts and polyps)
各类神经系统疾病---Nervous system disorders
妊娠期、产褥期及围产期状况---Pregnancy, puerperium and perinatal conditions
产品问题---Product issues
精神类疾病---Psychiatric disorders
肾脏及泌尿系统疾病---Renal and urinary disorders
生殖系统及乳腺疾病---Reproductive system and breast disorders
呼吸系统、胸及纵膈疾病---Respiratory, thoracic and mediastinal disorders
皮肤及皮下组织类疾病---Skin and subcutaneous tissue disorders
社会环境---Social circumstances
各种手术及医疗操作---Surgical and medical procedures
血管与淋巴类疾病---Vascular disorders