Study Site Standard Operating Procedures (SOPs)  
Study Site SOPs – PDF files
PRE STUDY 研究前
Pre-Study Visit 研究前訪視
Review of Protocol 試驗方案的審閱
Review of Protocol Amendments 試驗方案修訂案的審閱
Review of Investigator 's Brochure 研究者手冊的審閱
Review of Case Report Form 病例報告表的審閱
Study Organisation and Planning 研究的組織和計劃
Study Team: Definition of Responsibilities 研究小組:責任界定
Recruitment of Subjects 受試者招募
Pre-Study Planning of Investigational Products 研究前試驗產品的計劃
Pre-Study Planning for Laboratory Investigations 研究前實驗室檢查的計劃
Investigators' Meeting and Good Clinical Practice Training 研究者會議和臨床試驗規範培訓
Institutional Review Board Application and Communications 倫理委員會申請和溝通
TRIAL OPERATION 試驗的進行
Site Initiation Visit 基地啟動訪視
Blinding: Codes and Code Breaking 設盲:編碼和解碼
Investigational Products Accounting and Dispensing 試驗產品的交收記錄和分派
Case Report Form Completion 病例報告表的填寫
Obtaining Written Informed Consent 獲取書面知情同意
Adverse Event and Serious Adverse Event Reporting 不良事件和嚴重不良事件的報道
Monitoring Visit 監查訪視
Data Clarification 數據澄清
STUDY CLOSURE 結束研究
Study Closeout Visit 研究結束訪視
Archiving of Study Data 研究資料存檔
QUALITY ASSURANCE 品質保證
Audit 稽查
Inspection 視察

The Clinical Trials Centre has developed a set of generic study site SOPs that can be used at any site conducting sponsored or investigated-initiated human studies. The SOPs are provided both in English and in Chinese.

You are free to print the SOPs and use them at your site. The Principle Investigator at the site should preferably sign the SOPs.

Each study site is strongly advised to develop their own study site specific SOPs for all investigations that form the outcome of clinical research studies, e.g. blood pressure, blood samples, ECG, x-ray, pulmonary function, surgical procedures etc.

According to international recommendations study site staff should be trained annually on the contents of the SOPs and the educational activities should be documented.

Modified on 26 September, 2011. Home | Contact Info | Terms of Use | © 2005-2011 Clinical Trials Centre. All rights reserved.