cro領域臨床試驗醫(yī)學撰寫sop

1、CRO 領域臨床試驗醫(yī)學撰寫 領域臨床試驗醫(yī)學撰寫 SOP(中英文對照 中英文對照)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 requi

2、red to sign a SOP compliance statement stating that they will conform with the requirements of the SOP and specifying the SOPs under consideration. 所有的申辦者/CRO 工作人員應該發(fā)布最新版 SOP 文件，并且按照這些 SOP 進行臨床研究。他們應該簽署一個 SOP 依從的聲明，表明他們將

3、遵從 SOP 要求，并詳細說明該 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 supersede

4、d 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 Thus, all master copies of superseded SOPs must be retained in the clinical study files.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

5、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

6、 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

7、 immediately return SOPs.SOP 至少每年應審查一次，以確定是否需要新的 SOP 或修訂現行的 SOP（如果需要，或者因為緊急情況需要修改，則需要更頻繁修訂）。所有過時的 SOP 文件應該妥善保存，以備稽查和視察。所有的過時的 SOP 的主文件必須保存在臨床研究文件中，分發(fā)給公司其他部門個人的 SOP 參考文件可以保存在公司。如果需要外部機構承擔該任務，或分發(fā)給其他外部個體（如 CRO 公司），就必須獲得 SO

8、P 外部分發(fā)許可文件，以保護該文件的機密性。SOP 的接收者不可以影印該 SOP，或分發(fā)給其它的人，離開申辦者/CRO 公司的雇員必須立刻歸還 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 wit

9、h 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 i

10、mmediately to a designated person. Consistent and deliberate non-compliance with the SOPs without written authorization will lead to disciplinary action.在特殊情況下，發(fā)起遵守 SOP 是允許的，當事先知道不可能按照 SOP 完成時，但必須做出書面解釋并經過書面批準。故意或由于疏忽而違反

11、 SOP，必須被記錄，并做出解釋，立即報告給相關負責人。沒有書面授權的連續(xù)故意的違反 SOP 應該受到懲罰。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 indicat

12、es the revision number.SOP 的編號：每個 SOP 用 5 個數字序列編號，前三個數字用來標識該 SOP，后兩個數字表示版本號。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.頒布日期：是指該 SOP 生效日期，此日

13、期應該是在批準日期當天或之后。l Supersedes: the number and date of the SOP which preceded the current SOP will be indicated;更新：應該指出新版 SOP 之前的 SOP 的編號和頒布日期。l Last and next review dates: the last review date will be the dat

14、e 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 planne

15、d to be reviewed.上次審核日期和下次審核日期：上次審評日期是指該 SOP 上次被審核的日期，如果該 SOP 經審評后沒有變更，則“更新”項目的信息不變，下次審核日期是指計劃下次審評該 SOP 日期。l Approved by: the SOPs will be approved, with the dated signatures of at least one senior manager and sen

16、ior 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.批準：SOP 的批準最少要該部門一個高級經理和一個高級個體簽字和日期。批準是為了確認該 SOP 充分描述了

17、申請人或 CRO 用到的程序。Each SOP will include the following sections in the text:每個 SOP 的正文內容應該包括下面內容：l Table of contents: the table of contents will include a list of items included in the SOP, with page numbers;目錄：包括 S

18、OP 所含項目及其頁碼列表。l Introduction: the introduction should briefly describe the rationale and scope of the SOP;簡介：應當簡要描述依據和適用范圍。l Contents: the contents of the SOP will follow the order noted in the table of

19、 contents and, in general, will follow the order in which procedures occur;內容:SOP 的內容與目錄中的順序一致，一般情況下，內容應該按照操作發(fā)生的順序編寫。 l Appendices to the SOP will be numbered and listed in the order in which they are addressed