SOP(中英文对照)

1.3  STANDARD OPERATING PROCEDURES 标准操作程序

One of the requirements of GCP is that sponsors and any CRO to whom they contract research are required to have written standard operating procedures (SOPs) to describe necessary activities to accomplish various tasks. These SOPs are intended to interpret the guidelines and regulations so that they can be applied to a specific organization and answer the questions of who, when, where, why and how. They also provide the means of documenting compliance with GCP requirements. To implement and enforce the SOPs, other quality assurance and control procedures will be used - including training, monitoring and auditing - which are described in other chapters.

GCP其中的一个要求是，申办者和他们委托进行研究的CRO必须有书面的标准操作程序，用于描述完成各种任务所必要的规范，这些SOP意在详细解释指南和法规，因此可应用于特定的机构，并且回答谁做，什么时候做，在哪里做，为什么要做和如何做等问题，也提供了记录GCP依从性的方法。为了实施这些SOP文件，其他的质量保证和控制程序也要采用，包括：培训，监查和稽查，这些将在其他章节中描述。

    A SOP is a formal document which describes the procedures that will be followed to accomplish various tasks. The style of the text of the SOP should be clear, concise, brief and specific to the subject of the SOP. A SOP should be written to provide instructions for the completion of certain procedures and therefore must not be ambiguous or confusing. Statements concerning the procedures to be followed should be made categorical by the use of such words as 'must' and 'will' (e.g. 'the following procedure must/will be performed'). The word 'may' is to be used only when the conditions are stated (e.g. 'the investigator may enter a patient into the study without patient consent only in an emergency and when the patient is unconscious').Some guidelines for the format of SOPs are included in Checklist 1.3-1.

SOP是正式的文件，它描述了要完成各种任务所必须遵守的程序，其正文的格式应该式对使用者来说应该是清晰的、简洁的、简短的、有针对性的，应该提供完成某种程序的说明，所以，不能使用模棱两可的或易混淆的字眼，关于必须遵守的程序须明确申明，如使用“必须”和“要”（例如：下面的程序必须/要执行），“可以”只能用在陈述事件时（例如：只有当在一个急症或病人昏迷时，研究者才可以未经病人同意就让病人进入研究），一些 SOP格式的指南见表1.3-1。

(to be continued)