受試者知情同意過程記錄格式-ntuh.gov.tw.docVIP

受試者知情同意過程記錄格式(貼於病歷三號紙) 使用說明： 受試者參與臨床試驗或研究案，須於病歷記錄已提供受試者「臺大醫院臨床試驗/研究參與者須知」，以及“知情同意”決定過程、提供訊息者和獲得知情同意者姓名及日期，為利計畫人員執行，提供二種受試者知情同意過程記錄格式如下，格式一用於受試者接受充分說明後即簽署同意書；格式二用於受試者接受充分說明後，尚須帶回同意書考慮是否參加，之後再簽署同意書，故分開兩張張貼。 請選擇適用之格式或自行設計(但應有格式內之內容)，並張貼於病歷之三號紙。104.3.新增說明：電子病歷之記錄方式如下：將「知情同意過程記錄格式」內容載於電子病歷中(可載於SOAP中) 或 將「知情同意過程記錄格式」貼在「門診病歷紀錄掃描專用紙書寫病歷」，再交回病歷資訊管理室掃描存檔 格式內之文件編號為本格式版本，請勿更動。 格式一 (說明及同意書簽署同時進行) (格式二請見次頁) 格式二 (說明及同意書簽署分階段進行) (1)說明階段 (2)簽署同意書階段 NTUH-REC No.: Study Title： The subject has been provided the sheet of Clinical Trial/Research Note and was fully explained the content of the informed consent form on / / (yyyy/mm/dd) by □Principle Investigator □Co-Investigator □Other: (identity) :(name) . The subject had enough time to consider and ask all questions regarding the study. The subject had signed informed consent form on / / (yyyy/mm/dd). A copy of the signed informed consent form was provided to the subject. Principal Investigator\Co-Investigator： 01010-4-000001 版次 02 NTUH-REC No.: Study Title： The subject has been provided the sheet of Clinical Trial/Research Note and was fully explained the content of the informed consent form on / / (yyyy/mm/dd) by □Principle Investigator □Co-Investigator □Other: (identity) :(name) . The subject had enough time to ask all questions regarding the study. The subject brought the consent form back to consider whether to participate. Principal Investigator\Co-Investigator： 01010-4-000002 版次 02 NTUH-REC No.: Study Title： The subject understood the content of the informed consent form and signed informed consent form on / / (yyyy/mm/dd). A copy of the signed informed consent form was provided to the subject. Principal Investigator\Co-Investigator： 01010-4-000003 版次