临床试验或CRO领域的SOP翻译要求

   All sponsor/CRO personnel will be issued with copies of the most current SOPs and will be required to undertake clinical studies in accordance with those SOPs. They will be required to sign a SOP compliance statement stating that they will conform with the requirements of the SOP and specifying the SOPs under consideration.

所有的申办者/CRO工作人员应该发布最新版SOP文件，并且按照这些SOP进行临床研究。他们应该签署一个SOP依从的声明，表明他们将遵从SOP要求，并详细说明该SOP文件。

   SOPs will be reviewed at least annually (or more frequently, if necessary, because of urgently needed changes) to determine whether new SOPs or revisions to existing SOPs are needed. All superseded versions of SOPs must be available for audit and inspection. Thus, all master copies of superseded SOPs must be retained in the clinical study files. Reference copies of SOPs may be distributed to individuals in other departments within the company, if required for the task being undertaken, and may be distributed to other external individuals (e.g. a CRO, if required for the task being undertaken). Documented permission to distribute SOPs externally must be obtained to protect confidentiality. Individual recipients of SOPs should not photo- copy the SOPs or distribute them to other personnel and personnel leaving the employ of the sponsor/CRO should immediately return SOPs.

SOP至少每年应审查一次，以确定是否需要新的SOP或修订现行的SOP（如果需要，或者因为紧急情况需要修改，则需要更频繁修订）。所有过时的SOP文件应该妥善保存，以备稽查和视察。所有的过时的SOP的主文件必须保存在临床研究文件中，分发给公司其他部门个人的 SOP参考文件可以保存在公司。如果需要外部机构承担该任务，或分发给其他外部个体（如CRO公司），就必须获得SOP外部分发许可文件，以保护该文件的机密性。SOP的接收者不可以影印该SOP，或分发给其它的人，离开申办者/CRO公司的雇员必须立刻归还SOP文件。

    Under exceptional circumstances, waivers from the SOPs may be allowed, when it is known in advance that it will not be possible to comply with the SOP. Waivers from SOPs must be requested in writing, with an explanation, and require written approval. Violation of SOPs (deliberately or through negligence) must be documented, with an explanation, and reported immediately to a designated person. Consistent and deliberate non-compliance with the SOPs without written authorization will lead to disciplinary action.

在特殊情况下，发起遵守SOP是允许的，当事先知道不可能按照SOP完成时，但必须做出书面解释并经过书面批准。故意或由于疏忽而违反SOP，必须被记录，并做出解释，立即报告给相关负责人。没有书面授权的连续故意的违反SOP应该受到惩罚。

    The important topics which should be addressed in SOPs by sponsors and CROs are listed in Checklist 1.3-2. Clinical facilities conducting research on behalf of sponsors/CROs are also adopting written standards more frequently today and suggested topics are in Checklist 1.3-3. Of 84 different sets of sponsor/CRO SOPs which we have reviewed in the last few years, many important topics were not addressed: inspection by regulatory authorities (87% of SOPs did not include this topic); selection and management of clinical laboratories (77%);medication/device final disposition and destruction (74%);training and qualifications of personnel (70%); selection and management of CROs (68% of 44 sponsor SOP sets); detection and management of fraud (59%); financial payments to investigators (57%); medication/device packaging and labeling (57%); randomization procedures (54%); auditing (51%); medication/device requisition, shipment, receipt and management at the study site (48%); investigator contracts (43%); standard operating procedures (39%); investigator brochures (39%); clinical study reports (35%); source data verification procedures (35%);filing/archiving (33%); CRF (including diary card, quality of life assessment form, etc.) design (31%); protocol amendments(31%); study site initiation and closure(26%); ethics committees(26%); informed consent procedures (24%); and reporting of AEs (21%).

申办者或CRO必须涉及的SOP的重要主题见表 1.3-2. 现在，代表申办者或CRO进行临床研究的临床机构也更多采用书面标准操作规范，建议的主题见表1.3-3。在过去的几年里，我们审查的84家不同申办者 /CRO的SOP。许多重要的主题未涉及。管理当局视察(87%的SOP没有包含该主题) ; 临床实验室的选择和管理 (77%);药物/器械最终处置和销毁(74%);研究人员的培训和资格证明 (70%); CRO公司的选择和管理 (44个申办者的SOP有68%未涉及); 作假的检查和管理(59%);给研究者的财务付款 (57%);药物/器械的包装和标签(57%);随机化程序(54%); 稽查(51%);在研究基地的药物/器械的申请，运输，接收和管理(48%);研究者协议(43%);标准操作程序(39%);研究者手册(39%);临床研究报告(35%);原始数据验证程序(35%);归档(33%); CRF设计(包括日志卡，生活质量评估表等等.) (31%); 方案修补(31%);研究基地的启动和关闭(26%); 伦理委员会(26%); 知情同意程序(24%); AE报告 (21%).

 Checklist 1.3-1. Suggestions for the Format and Contents of SOPs                           

表1.3-1 sop的格式和内容建议

Each SOP will provide the following information on the first page:

每个SOP必须在第一页提供以下内容：

l        Title: the title will comprise one or two lines indicating the subject of the SOP;

题目：题目一行或两行组成，以表明该SOP的主题。

l        SOP number: each SOP will be numbered sequentially using five digits. The first set of three digits identifies a SOP and the second set of two digits indicates the revision number.

SOP的编号：每个SOP用5个数字序列编号，前三个数字用来标识该SOP，后两个数字表示版本号。

l        Issue date: this will be the date on which the SOP will take effect. It   will be on or after the date of approval.

颁布日期：是指该SOP生效日期，此日期应该是在批准日期当天或之后。

l        Supersedes: the number and date of the SOP which preceded the current SOP will be indicated;

更新：应该指出新版SOP之前的SOP的编号和颁布日期。

l        Last and next review dates: the last review date will be the date on   which the SOP was last reviewed. If the SOP remains unchanged after the review, the details for 'supersedes' will not change. The next review date will be the next scheduled date on which the SOP is planned to be reviewed.

上次审核日期和下次审核日期：上次审评日期是指该SOP上次被审核的日期，如果该SOP经审评后没有变更，则“更新”项目的信息不变，下次审核日期是指计划下次审评该SOP日期。

l        Approved by: the SOPs will be approved, with the dated signatures of at least one senior manager and senior individual in the department to whom the SOP applies. The approvals confirm that the SOPs adequately describe the procedures developed and used by the sponsor/CRO.

批准：SOP的批准最少要该部门一个高级经理和一个高级个体签字和日期。批准是为了确认该SOP充分描述了申请人或 CRO用到的程序。

Each SOP will include the following sections in the text:

每个SOP的正文内容应该包括下面内容：

l        Table of contents: the table of contents will include a list of items   included in the SOP, with page numbers;

目录：包括SOP所含项目及其页码列表。

l        Introduction: the introduction should briefly describe the rationale   and scope of the SOP;

简介：应当简要描述依据和适用范围。

l        Contents: the contents of the SOP will follow the order noted in the   table of contents and, in general, will follow the order in which   procedures occur;

内容:SOP的内容与目录中的顺序一致，一般情况下，内容应该按照操作发生的顺序编写。

l        Appendices to the SOP will be numbered and listed in the order in which they are addressed in the SOP. Appendices will be designated by Roman numerals (e.g. Appendix I) and placed at the end of the SOP, with each page numbered.

SOP的附录应该编号并且按照其在SOP中出现的顺序列出，并且要用罗马数字标示（例如：附录I)，放在SOP的最后面，且有页码。

        Checklist 1.3-2. Topics for SOPs for Sponsors/CROs

表1.3-2 申办者/CRO公司的SOP的主题

Sponsors/CROs should address the following topics in SOPs:

申办者/CRO在编写的SOP中应该涉及下列主题：

l        General topics: general quality assurance and quality control procedures; clinical development plans; clinical study plans; clinical study   tracking; clinical research personnel qualifications; clinical audits;   regulatory authority inspections; fraud;

一般主题：一般质量保证和质量控制程序；临床开发计划；临床研究计划；临床研究追踪；临床研究人员资格；临床稽查；管理当局的视察；作假。

l        Ethics: initial and continuing review by ethics committees/IRBs;   membership; working procedures; informed consent; consent forms and information sheets; exceptions to normal informed consent procedures;

伦理：伦理委员会/IRB初次及后续审评；成员要求；工作程序；知情同意；同意书和信息列表；非常规的知情同意程序。

l        Study setup: investigator brochures; protocols; protocol amendments; CRFs; submissions to regulatory authorities; selection visits;

   Phase I facilities; agreements (e.g. responsibilities, financial, confidentiality, insurance/indemnity agreements); selection of CROs; selection of clinical laboratories; initiation visits; personnel; startup meetings;

准备研究：研究者手册；方案，方案修正；CRF；管理当局的申请；选择访视；

I期实验室；合同（例如：职责，财务，保密，保险或补偿协议）；CRO公司的选择；临床实验室的选择；启动访视，人员；启动会。

l        Monitoring and initial data review: monitoring visits; source data

   verification; CRF review; CRF tracking; data query; database development, review and lock; data conventions; study subject classification; statistical review;

监查和初步的数据的核查：监查访视；原始数据的确认；CRF核查；CRF追踪；数据质疑；数据库的建立、审核和锁定；数据协定，受试者分组，统计审查。

l        Management of study medications/devices and clinical laboratory   samples: request for study medications/devices; labeling and packaging; shipment; receipt; control at study sites; dispensing; inventory;   compliance with use of study medication/device; final disposition;   final reconciliation; recall; reallocation; randomization procedures;   clinical laboratory samples;

研究用药物/器械和临床实验室样本的管理：研究用药物/器械预算；标签和包装；运输；接收；研究基地的管理；分发；存贮；研究用药物/器械使用的依从性；最终的处置；最终的调节，召回；再分配，随机化程序，临床实验室样本。

l        Safety event reporting: definitions; recording and reporting AEs;   reporting safety information externally.

安全事件报告：定义；不良事件记录和报告；向外部报告安全信息。

l        Closing the study: closure visits; clinical study reports; premature   termination or suspension; archiving.

结束研究：关闭探视，临床研究报告；提前终止或暂停；归档。

          Checklist 1.3-3. Topics for SOPs for Investigators

表1.3-3 研究者SOP的主题

The following topics are suggestions for inclusion in study site SOPs:

研究基地的SOP建议包括下面主题：

l        General topics: general quality assurance and quality control procedures; clinical research personnel qualifications; clinical audits; regulatory authority inspections; fraud;

一般主题：一般质量保证和质量控制程序；临床研究人员资格；临床稽查；管理当局的视察；作假。

l        Ethics: initial and continuing review by ethics committees/IRBs;   membership; working procedures; informed consent; consent forms and information sheets; exceptions to normal informed consent procedures;

伦理：伦理委员会/IRB初次和后续审评；成员要求；工作程序，知情同意，同意书和信息列表；非常规的知情同意程序。

l        Study setup: review of investigator brochures, protocols, protocol   amendments, CRFs; agreements (e.g. responsibilities, financial, confidentiality, insurance/indemnity agreements);

研究准备：研究者手册；方案，方案修正；CRF；协议（例如：职责，财务，保密，保险或补偿协议）

l        Monitoring and initial data review: monitoring visits; source data   verification; data query;

监查和初步的数据的核查：监查访视，原始数据确认，数据质疑。

l        Management of study medications/devices and clinical laboratory   samples: shipment; receipt; control at study sites; dispensing; inventory; compliance with use of study medication/device; final disposition;  final  reconciliation;  randomization  procedures;  clinical laboratory samples;

研究用药物/器械和临床实验室样本的管理：研究用药物/器械预算；标签和包装；运输；接收；研究基地的管理；分发；存贮；研究用药物/器械使用的依从性；最终的处置；最终的调节，随机化程序，临床实验室样本。

l        Safety event reporting: definitions; recording and reporting AEs;   recording and reporting AEs to ethics committees;

安全事件报告：定义；不良事件的记录和报告；不良事件向伦理委员会汇报。

l        Closing the study: review of clinical study reports; premature termination or suspension; archiving.

结束研究：临床研究报告审核；提前终止或暂停，归档。