-OECD-Good-laboratory-practice-(GLP)中英文对照PPT版-PPT课件.ppt

1、OECD GLP Principles经济合作与发展组织GLP 原则Suzhou Research-LeoLiu西山中科-刘振超9.Reporting of Study Results报告9.1 General 总则9.1.1A final report should be prepared for each study.In the case of short term studies,a standardised final report accompanied by a study specific extension may be prepared.9.1.1应当为每个专题起草最终报告

2、。对于短期专题，可以使用标准报告和专题具体补充。9.Reporting of Study Results报告9.1 General 总则9.1.2Reports of Principal Investigators or scientists involved in the study should be signed and dated by them.9.1.2 PI和（对专题做出贡献的）科学家（们）的报告应当得到他们亲自签署。9.Reporting of Study Results报告9.1 General 总则9.1.3The final report should be signed

3、 and dated by the Study Director to indicate acceptance of responsibility for the validity of the data.The extent of compliance with these Principles of Good Laboratory Practice should be indicated.9.1.3最终报告一定要得到SD的签署，表示SD愿意对数据有效性负责。最终报告要标明专题遵从GLP原则的程度；9.Reporting of Study Results报告9.1 General 总则9.1

4、.4Corrections and additions to a final report should be in the form of amendments.Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director.9.1.4对最终报告的修正和补充应当以最终报告变更的形式体现。此变更要清晰的体现所修正和补充的内容及原因，并得到SD的签署。9.Reporting of Study Resu

5、lts报告9.1 General 总则9.1.5Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction,addition or amendment to the final report.9.1.5为满足注册要求，对最终报告格式的修改不构成对最终报告的变更。9.Reporting of Study Results报告9.2 Conte

6、nt of the Final Report最终报告的内容The final report should include,but not be limited to,the following information:最终报告应当包含，但不局限于以下信息：9.2.1 Identification of the Study,the Test Item and Reference Item.9.2.1专题、供试品和对照品的标识。9.Reporting of Study Results报告9.2 Content of the Final Report最终报告的内容9.2.1a)A descripti

7、ve title;9.2.1a)描述性标题（专题名称）；9.2.1b)Identification of the test item by code or name(IUPAC,CAS number,biological parameters,etc.);9.2.1b)供试品的标识（IUPAC、CAS号、生物参数等）；9.Reporting of Study Results报告9.2 Content of the Final Report最终报告的内容9.2.1c)Identification of the reference item by name;9.2.1c)对照品的标识（通过名称）；

8、9.2.1d)Characterisation of the test item including purity,stability and homogeneity.9.2.1d)供试品的属性包括纯度（含量）、稳定性和均一性。9.Reporting of Study Results报告9.2 Content of the Final Report最终报告的内容9.2.2Information Concerning the Sponsor and the Test Facility委托方和试验机构的信息9.2.2a)Name and address of the sponsor;9.2.2a)

9、委托方的名称和地址；9.2.2b)Name and address of any test facilities and test sites involved;9.2.2b)测试机构和测试场所的名称和地址；9.Reporting of Study Results报告9.2 Content of the Final Report最终报告的内容9.2.2Information Concerning the Sponsor and the Test Facility委托方和试验机构的信息9.2.2c)Name and address of the Study Director;9.2.2c)SD的

10、姓名和地址；9.2.2d)Name and address of the Principal Investigator(s)and the phase(s)of the study delegated,if applicable;9.2.2d)PI的姓名和地址，SD指定PI负责的专题的阶段；9.Reporting of Study Results报告9.2 Content of the Final Report最终报告的内容9.2.2Information Concerning the Sponsor and the Test Facility委托方和试验机构的信息9.2.2e)Name an

11、d address of scientists having contributed reports to the final report.9.2.2e)对最终报告做出贡献的科学家的姓名和地址。9.Reporting of Study Results报告9.3 Dates日期9.3.1 Experimental starting and completion dates.9.3.1试验开始和结束日期。9.Reporting of Study Results报告9.4 Statement日期9.4.1 A Quality Assurance Programme statement listin

12、g the types of inspections made and their dates,including the phase(s)inspected,and the dates any inspection results were reported to management and to the Study Director and Principal Investigator(s),if applicable.This statement would also serve to confirm that the final report reflects the raw dat

13、a.9.4.1质量保证声明列举所进行的检查及检查日期，包括所检查的专题阶段、将检查结果报告给机构负责人和SD（PI）的日期。这份声明也被用于确认最终报告如实反映了原始数据。9.Reporting of Study Results报告9.5 Description of Materials and Test Methods方法和物品的描述9.5a)Description of methods and materials used;9.5a)对（专题）所使用的方法和物品的描述；9.5b)Reference to OECD Test Guideline or other test guideline

14、 or method.9.5b)对OECD测试指导和其他测试指导和方法的参照。9.Reporting of Study Results报告9.6 Results结果9.6a)A summary of results;9.6a)结果的摘要；9.6b)All information and data required by the study plan;9.6b)试验方案需要的信息和数据；9.Reporting of Study Results报告9.6 Results结果9.6c)A presentation of the results,including calculations and d

15、eterminations of statistical significance;9.6c)对结果的陈述，包括计算和统计显著性的决定。9.Reporting of Study Results报告9.6 Results结果9.6d)An evaluation and discussion of the results and,where appropriate,conclusions.9.6d)对结果的评估和讨论，需要时，给出结论。9.Reporting of Study Results报告9.7 Storage贮存9.7.1 The location(s)where the study plan,samples of test and reference items,specimens,raw data and the final report are to be stored.9.7.1试验方案、供试品和对照品的样品、标本、原始数据和最终报告的贮存地点。