已翻译完 21CFR PART 312 Subpart A, Subpart B,Subpart C和Subpart D合集,一起来看看吧~
Subpart A - General Provisions一般规定
§ 312.1 Scope. 范围 和§ 312.2 Applicability 适用性PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-1
§ 312.3 Definitions and interpretations. 定义和解释 PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-2
§ 312.6 Labeling of an investigational new drug. 研究用新药标签 PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-3
§ 312.7 Promotion of investigational drugs. 研究用药物的推广 PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-4
§ 312.8 Charging for investigational drugs under an IND. IND下的研究用药物收费 PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-5
§ 312.10 Waivers. 豁免 PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-6
Subpart B - Investigational New Drug Application (IND) IND申请
§ 312.20 Requirement for an IND. IND要求 PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-7
§ 312.21 Phases of an investigation. 研究分期 21CFR PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-8
§ 312.22 General principles of the IND submission. IND提交的一般原则。21CFR PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-9
§312.23 IND content and format. IND内容和格式 21CFR PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-10
§ 312.30 Protocol amendments. 方案修订 21CFR PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-11
§ 312.31 Information amendments. 信息修订 21CFR PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 中英文-12
§ 312.32 IND safety reporting. IND安全性报告 21CFR PART 312 - § 312.32 IND safety reporting. IND安全性报告 (中英文)
§ 312.33 Annual reports. 年报 21CFR PART 312 - § 312.33 Annual reports 年报 (中英文)
§ 312.38 Withdrawal of an IND. IND的撤回 21CFR PART 312 - § 312.38 Withdrawal of an IND. IND的撤回(中英文)
Subpart C - Administrative Actions 管理操作
21CFR PART 312 - § 312.40 临床研究中使用研究用新药的一般要求(中英文)
21CFR PART 312 - § 312.41 对IND的评论和建议(中英文)
21CFR PART 312 - § 312.42 临床搁置和修改要求(中英文)
21CFR PART 312 - § 312.44 Termination. 终止(中英文)
21CFR PART 312 - § 312.45 Inactive status. 非活状态(中英文)
21CFR PART 312 - § 312.47 Meetings. 会议(中英文)
21CFR PART 312 -§ 312.48 Dispute resolution. 争议解决(中英文)
Subpart D—Responsibilities of Sponsors and Investigators 申办方和研究者的职责
21CFR PART 312 -§ 312.52 将义务转移给合同研究机构CRO(中英文)
21CFR PART 312 -§ 312.53 选择研究者和监察员(中英文)
21CFR PART 312 -§ 312.54 本章§50.24的紧急研究(中英文)
21CFR PART 312 -§ 312.55 Informing investigators. 通知研究者(中英文)
21CFR PART 312 -§ 312.56 审查正在进行的研究。(中英文)
21CFR PART 312 -§ 312.57 记录和记录保留(中英文)
21CFR PART 312 -§ 312.58 检查申办方的记录和报告(中英文)
21CFR PART 312 -§ 312.59 未使用的试验用药品的处理(中英文)
21CFR PART 312 -§ 312.60 研究者的一般责任(中英文)
21CFR PART 312 -§ 312.61 对试验药物的管控(中英文)
21CFR PART 312 -§ 312.62 研究者记录和记录保存(中英文)
21CFR PART 312 -§ 312.64 Investigator reports. 研究者报告(中英文)
21CFR PART 312 -§ 312.66 Assurance of IRB review. IRB审查保障(中英文)
21CFR PART 312 -§ 312.68 检查研究者的记录和报告(中英文)
21CFR PART 312 -§ 312.69 受控物质处理(中英文)
21CFR PART 312 -§ 312.70 取消临床研究者的资格(中英文)
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