ICH-GCP12.2InvestigationalNewDrugs（2）Contents
Part 4: Investigational New Drugs Responsibilities
Part 5: Summary of Key Points
Part 4: Investigational New Drugs Responsibilities 新药研究责任
Responsibilities of Sponsor 发起⼈的责任
Both sponsors and investigators who are involved in conducting a clinical trial under an IND filed with the FDA must accept and fulfill certain responsibilities.
参与根据向FDA提交的IND进⾏临床试验的发起⼈和研究者必须接受并履⾏某些责任。
Sponsors' responsibilities include:
Ⅰ、Selecting qualified investigators.
Ⅱ、Providing investigators with the information they need to conduct the investigation.
Ⅲ、Ensuring proper monitoring of the trial.
Ⅳ、Ensuring the trial is conducted according to the plan and protocols contained in the IND.
Ⅴ、Informing the FDA and all investigators of significant new adver effects or risks that are reasonably likely to be caud by the investigational new drug.
Ⅵ、Maintaining proper records.
Ⅶ、Disposing of unud supplies of the investigational new drug.
发起⼈的责任包括：
⼈员。
1、选择合格的调查⼈员
信息。
2、向调查⼈员提供开展调查所需的信息
3、确保对试验进⾏适当的监督
监督。
古代鬼故事
确保试验按照IND中包含的计划和⽅案进⾏。
4、确保试验按照IND中包含的计划和⽅案进⾏
不良反应或风险。
5、告知FDA和所有研究⼈员试验新药合理可能引起的重⼤新不良反应或风
记录。
6、保持适当的记录
处置未使⽤的研究新药供应。
7、处置未使⽤的研究新药供应
天竺鼠Unless the sponsor is a sponsor-investigator, the sponsor does not actually conduct the investigation.
除⾮发起⼈是发起⼈调查⼈，否则发起⼈实际上不进⾏调查。
Bad on GCP guidelines, other Sponsor responsibilities include (ICH GCP E6, 5.12; 5.13; 5.14):
Ⅰ、Ensuring that the Investigational Product is manufactured in accordance with Good Manufacturing Practices.
Ⅱ、Ensuring that Investigational Product is packaged in a way that prevents contamination and unacceptable deterioration during transport and storage.
Ⅲ、Supplying investigators/institutions with the Investigational Product.
Ⅳ、Having written procedures that include instructions on the handling and storage of Investigational product that sites should follow.
Ⅴ、Maintaining sufficient quantities of the Investigational Product ud in the trial to reconfirm specifications should the need ari.
潮汕肠粉根据GCP指南，其他赞助商责任包括（ICH GCP E6，5.12；5.13；5.14）：
良好的⽣产规范。
1、确保试验产品的⽣产符合良好的⽣产规范
包装⽅式能够防⽌运输和储存过程中的污染和不可接受的变质。
2、确保试验产品的包装⽅式能够防⽌运输和储存过程中的污染和不可接受的变质
提供试验药物。
3、向调查⼈员/机构提供试验药物
书⾯程序，包括现场应遵循的试验药物处理和储存说明。
4、具有书⾯程序
⾜够数量的试验药物，以在需要时重新确认规范。
5、保留试验中使⽤的⾜够数量的试验药物
The above reprent good examples of responsibilities the Sponsor may transfer to a Contract Rearch Organization (CRO), such as a clinical coordinating center. However, the ultimate responsibility for Investigational Product resides with the Sponsor. Any Investigational Product-related duties and functions that are transferred to and assumed by a CRO are specified in writing.
⼀个好的研究中⼼（CRO）的临床责任可能会转移到上述的研究中⼼。然⽽，研究药物的最终责任在
于申办⽅。移交给⾸席风险官并例如，⼀个好的研究中⼼（CRO）的临床责任可能会转移到上述的研究中⼼
由⾸席风险官承担的任何与试验药物相关的职责和职能均以书⾯形式规定。
Responsibilities of Investigators 调查员的责任
Investigators' responsibilities include:
Ⅰ、Providing the sponsor with a completed, signed Statement of Investigator. (Form FDA 1572. Click here for instructions on completing this form.)
Ⅱ、Conducting the trial in accordance with the signed investigator statement, protocol, and applicable regulations.
Ⅲ、Protecting the rights, safety, and welfare of trial participants.
Ⅳ、Obtaining informed connt from all trial participants.
Ⅴ、Maintaining proper records.
Ⅵ、Furnishing all required progress reports, safety reports, financial disclosure reports, and a final report.
Ⅶ、Complying with Institutional Review Board review. and
Ⅷ、Ensuring the proper handling of controlled substances.
调查⼈员的职责包括：
研究⼈员声明。（FDA 1572表格。点击此处获取填写此表格的说明。）
1、向申办⽅提供⼀份完整、签字的研究⼈员声明
签署的研究者声明、⽅案和适⽤法规进⾏试验。
2、根据签署的研究者声明、⽅案和适⽤法规进⾏试验
保护试验参与者的权利、安全和福利。
3、保护试验参与
知情同意。
4、获得所有试验参与者的知情同意
传神的拼音记录。
5、保持适当的记录
进度报告、安全报告、财务披露报告和最终报告
最终报告。
6、提供所有要求的进度报告、安全报告、财务披露报告
审查。和
7、遵守机构审查委员会的审查
处理。
8、确保受控物质的正确处理
This topic is also discusd in the Roles and Responsibilities module.
⾓⾊和职责模块中也讨论了此主题。
Bad on GCP guidelines, other Investigator responsibilities include (ICH GCP E6, 4.6):
Ⅰ、Ensuring Investigational Product accountability
Ⅱ、Assigning duties for Investigational Products to a pharmacist or an appropriate individual who has the necessary licen for dispensing
Ⅲ、Maintaining records of the Investigational Product from delivery at the site to dispensing to the participant as well as u by the participant, return by the participant, and reconciling all product prior to destruction.
Ⅳ、Ensuring that the Investigational Product is ud in accordance with the approved protocol
Ⅴ、Explaining the correct u of the Investigational Product to each participant and checking at intervals that each participant is following instructions properly.
根据GCP指南，其他研究者职责包括（ICH GCP E6，4.6）：
责任名言励志
1、确保试验产品的责任
2、将试验药物的职责分配
试验药物的职责分配给药剂师或具有必要配药许可证的适当个⼈
保存试验药物从现场交付到分配给参与者以及参与者使⽤、参与者返还以及销毁前核对所有药物的记录。
3、保存试验药物从现场交付到分配给参与者以及参与者使⽤、参与者返还以及销毁前核对所有药物的记录。
⽅案
4、确保试验产品的使⽤符合批准的⽅案
5、向每位参与者解释试验药物的正确使⽤，并每隔⼀段时间检查每位参与者是否正确遵守说明。
Clinical Trial Network（CTN） related content
Click to view Clinical Trial Network（CTN）
Why is the regulation of investigational new drugs relevant to the Clinical Trials Network? 为什么研究新药的监管与临床试验⽹络相关？
Studies performed within the NIDA Clinical Trials Network (CTN) that involve an investigational drug must be carried out in accordance with the investigational new drug regulations.
涉及研究药物的研究必须按照研究新药条例进⾏。
在NIDA临床试验⽹络（CTN）内进⾏的涉及研究药物的研究必须按照研究新药条例进⾏
The investigational new drug regulations are enacted to:
Ⅰ、Protect the safety of rearch participants,
Ⅱ、Ensure that participants are not expod to experimental drugs or procedures unnecessarily, and
Ⅲ、Protect participants' rights.
制定新药研究条例的⽬的是：
1、保护研究参与者的安全
保护研究参与者的安全，
不会不必要地接触实验药物或程序，以及
2、确保参与者不会不必要地接触实验药物或程序
权利。
3、保护参与者的权利
It is important, however, that all members of the CTN — not only tho involved with studies of investigational new drugs —understand the basics of the important regulations becau the reasoning behind the investigational drug regulations applies to all rearch involving human participants, including the International Council for Harmonization Good Clinical
Practice guidelines.
研究药物法规背后的理由然⽽，重要的是CTN的所有成员——不仅仅是那些参与实验性新药研究的成员了解这些重要法规的基础知识
参与实验性新药研究的成员了解这些重要法规的基础知识，因为研究药物法规背后的理由适⽤于所有涉及⼈类参与者的研究，包括国际协调理事会良好临床实践指南。
适⽤于所有涉及⼈类参与者的研究
The principles are equally applicable to behavioral rearch, or to medication studies not requiring an IND, even though
the studies do not involve an investigational new drug. Rearch participants should not be expod to any experimental intervention unnecessarily, in an unsafe manner, or in a manner that fails to protect their rights.
研究参与者不应以不安全的⽅式或⽆法保护其权利这些原则同样适⽤于⾏为研究，或不需要IND的药物研究，即使这些研究不涉及研究新药。研究参与者不应以不安全的⽅式或⽆法保护其权利的⽅式不必要地接受任何实验⼲预。
的⽅式不必要地接受任何实验⼲预
Although behavioral studies and IND-exempt medication studies conducted in the CTN are not subject to the requirement to submit IND safety reports to the FDA, CTN members who conduct suc
h studies must submit Adver Event/Serious Adver Event information and reports to the DSMB Medical Monitor at NIDA. All CTN members should be familiar with the similarities and differences in terminology and reporting requirements between reports required by NIDA and tho required by the FDA.尽管在CTN中进⾏的⾏为研究和⾮抗IND药物研究不受向FDA提交IND安全性报告的要求，但进⾏此类研究的CTN成员必须向NIDA的DSMB医疗监测机构提交不良事件/严重不良事件信息和报告。所有CTN成员应熟悉NIDA要求的报告与FDA要求的报告在术语和报告要求⽅⾯的异同。
Guidance Documents 指导⽂件
The FDA has incorporated the concept of Good Clinical Practice (GCP) into agency guidance documents, which are intended
to help rearchers comply with GCP regulations. Guidance on Good Clinical Practice may be found in the following documents:
FDA已将良好临床实践（GCP）的概念纳⼊机构指导⽂件，旨在帮助研究⼈员遵守GCP法规。关于良好临床实践的指导可在以下⽂件中找到：
Ⅰ、FDA’s Good Clinical Practice: Consolidated Guideline (April 1996)
Ⅱ、Clinical Investigation of Medicinal Products in the Pediatric Population
Ⅲ、Choice of Control Group and Related Issues in Clinical Trials (May 2001)
Ⅳ、Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators (2015)
1、FDA的良好临床实践：综合指南（1996年4⽉）
2、⼉科⼈群中药品的临床调查
3、临床试验中对照组的选择及相关问题（2001年5⽉）
4、赞助研究者准备和提交的研究性新药申请（2015年）
Although the guidance documents are not binding, they reflect the FDA’s current thinking about the interpretation of the regulations. Many guidance documents are available on the FDA’s Website. (Click here for a list of available guidance documents.) Guidance documents are also published in the Federal Register.
尽管这些指导⽂件没有约束⼒，但它们反映了FDA⽬前对法规解释的想法
尽管这些指导⽂件没有约束⼒，但它们反映了FDA⽬前对法规解释的想法。FDA⽹站上提供了许多指导⽂件。（单击此处查看可⽤指导⽂件的列表）指导⽂件也发表在《联邦公报》上。
Guidance documents ud internationally include both the:
Ⅰ、International Conference on Harmonization Good Clinical Practice guidelines E6, and
歌舞升平是什么意思
Ⅱ、International Conference on Harmonization Good Clinical Practice guidelines E8.
国际上使⽤的指导⽂件包括：
1、国际协调会议良好临床实践指南E6，以及
2、国际协调会议良好临床实践指南E8。
Interactive: Investigational New Drugs 研究新药
U r s a r e instr uc ted a s fo llo w s: ⽤户须知如下：
rs a
什么叫平面图形
The three investigators below are planning clinical trials that involve substance abu treatment. Read about each of their trials, and then make a decision: Which Investigator needs to file an Investigational New Drug Application prior to initiating the study? Then, consider the feedback.
下⾯的三位研究⼈员正在计划进⾏涉及药物滥⽤治疗的临床试验。阅读他们的每项试验，然后做出决定：哪位研究者需要在开始研究之前提交⼀份研究性新药申请？然后，考虑反馈。行政领导
A) Dr. Alvin
Marketed drug with a change in the indication
Dr. Alvin’s trial will e if participants taking a marketed drug, currently ud to treat anxiety, will have any u for relap prevention in adults with cocaine dependence. Dr. Alvin is planning a small pilot study first, using the drug at dos currently
