OECD

Section II 1.2.1

The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.

Section II 1.2.2

These responsibilities should include, but not be limited to, the following functions. The Study Director should:

FDA

58.33

For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that:

三者一致

CFDA

第三章第九条　　

（一）以签署姓名和日期的方式批准试验方案和试验方案变更，并确保质量保证人员、试验人员及时获得试验方案和试验方案变更的副本；

OECD

Section II 1.2.2.

(a) approve the study plan and any amendments to the study plan by dated signature;

(b) ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study;

(c) ensure that study plans and amendments and Standard Operating Procedures are available to study personnel;

FDA

58.33

(a) The protocol, including any change, is approved as provided by Sec. 58.120 and is followed.

三者基本一致

仅OECD中特别指出在研究的实施过程中SD应与QA保持有效的沟通，这一点其实也是非常有必要的。

FDA并未在SD职责中规定确保QA获取试验方案和试验方案变更的副本，但在QA的职责中规定QA应保存试验方案和试验方案变更的副本。

在试验方案和试验方案变更副本的获取时限上，CFDA与OECD均提出及时的要求，而FDA并提出要求。

CFDA

第三章第九条

（二）及时提出修订、补充标准操作规程相关的建议；

OECD

-

FDA

-

仅CFDA对SD提出该要求。

CFDA

第三章第九条　

（三）确保试验人员了解试验方案和试验方案变更、掌握相应标准操作规程的内容，并遵守其要求，确保及时记录研究中发生的任何偏离试验方案或者标准操作规程的情况，并评估这些情况对研究数据的质量和完整性造成的影响，必要时应当采取纠正措施；

OECD

Section II 1.2.2.

(e) ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study;

FDA

58.33

(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.

三者要求基本一致；

CFDA与OECD的描述具体至对方案和SOP的偏离，而FDA描述的更为广泛一些，包含可能影响研究质量和完整性的意料之外的情况。

对于SOP的偏离，OECD要求简单，SD知晓，并未描述评估与纠正方面的要求。

CFDA

第三章第九条　　

（四）掌握研究工作的进展，确保及时、准确、完整地记录原始数据；

OECD

Section II 1.2.2

(f) ensure that all raw data generated are fully documented and recorded;

FDA

58.33

(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.

对于原始数据的记录要求是一致的；

CFDA中指出SD的职责是要确保及时、准确、完成的记录；

FDA则指出SD的职责不仅要确保记录也要确保被复核，同时要求SD确保观察到的测试系统出现的预料之外的情况也被记录并复核。

CFDA

第三章第九条　　

（五）及时处理质量保证部门提出的问题，确保研究工作符合本规范的要求；

OECD

-

FDA

58.33

(e) All applicable good laboratory practice regulations are followed.

仅CFDA对SD提出要求，及时处理QA部门提出的问题。

CFDA

-

OECD

-

FDA

58.33

(d) Test systems are as specified in the protocol.

仅FDA对SD提出该要求。但CFDA与OECD在描述方案中应包含内容时，均包含实验系统。

CFDA

第三章第九条　　

（六）确保研究中所使用的仪器设备、计算机化系统得到确认或者验证，且处于适用状态；

OECD

Section II 1.2.2

(g) ensure that computerised systems used in the study have been validated;

FDA

-

OECD中仅提到了计算机化系统，而CFDA的要求还包含研究中使用的仪器设备，更为全面。

CFDA

第三章第九条　　

（七）确保研究中给予实验系统的受试物、对照品制剂得到充分的检测，以保证其稳定性、浓度或者均一性符合研究要求；

OECD

-

FDA

-

仅CFDA对SD提出该要求。

CFDA

第三章第九条　　

（八）确保总结报告真实、完整地反映了原始数据，并在总结报告中签署姓名和日期予以批准；

OECD

Section II 1.2.2

(h) sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these Principles of Good Laboratory Practice;

FDA

-

与报告相关的工作，SD的职责要求是一致的，

但CFDA描述的角度为SD的职责下应该做什么工作；OECD描述的角度则为SD在报告中签字所代表的意义。

CFDA

第三章第九条　　

（九）确保试验方案、总结报告、原始数据、标本、受试物或者对照品的留样样品等所有与研究相关的材料完整地归档保存；

OECD

Section II 1.2.2

(i) ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.

FDA

58.33

(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

同：

什么需要被归档，要求一致

异：

CFDA在第四十一条中规定项目结束后不超过两周归档

FDA要求在研究结束阶段或结束时进行归档

OECD要求研究结束后归档，并且特别指出该条对终止的研究同样适用

CFDA

第三章第九条　　

（十）在多场所研究中，确保试验方案和总结报告中明确说明研究所涉及的主要研究者、主研究场所、分研究场所分别承担的任务；

OECD

Section II 1.2.2

(d) ensure that the study plan and the final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study;

FDA

-

CFDA与OECD要求一致。

CFDA

第三章第九条　　

（十一）多场所研究中，确保主要研究者所承担部分的试验工作符合本规范的要求。

OECD

Section II 1.3

The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice.

FDA

-

异：

CFDA要求SD确保PI所承担的工作符合GLP;

而OECD中则是PI负责确保所承担的工作符合GLP。