臨床研究資料庫諮詢單(PICOTS)
Application form of PICOTS

臺北醫學大學數據處臨床數據中心APP01
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申請者應符合下列資格之一: 
1) 北醫及附屬醫院之專任人員; 
2) 其他經委員會專案審議通過者。
Please fill in appliers name and make sure he/she has the following identities: 
1)Full-time staff of TMU or its affiliated hospitals; 
2)Other projects approved by the committee.
申請者 *
Applicant
請填姓名
電子郵件地址 *
E-mail
院別 *
Institution: 北醫大, TMU; 附醫, TMUH; 萬芳, WFH; 雙和, SHH
單位 *
Department
職稱 *
Job title
欲申請之資料Setting (S) *
Hospitals: 附醫, TMUH; 萬芳, WFH; 雙和, SHH
Required
欲申請資料區間Timing (T) *
(e.g. 2008/01/01-2022/12/31)
(1)臨床問題Question *
(請以PICO方式建構臨床問題)
(2)假設Hypothesis *
(以下請依上述臨床問題(PICO),規劃研究假設及操作型定義)
(3)研究對象Patient / Population (P) *
e.g. 用以下條件定義: 診斷diagnosis (ICD9-CM, ICD-10) , 藥品medication (ATC), 處置procedure, 衛材material, 檢驗laboratory, 病理pathology, 醫囑order/費用fee (NHI Fee Schedule)
(4)研究對象納入條件 (Inclusion criteria) *
e.g. 用以下條件篩選: 診斷diagnosis (ICD9-CM, ICD-10) , 藥品medication (ATC), 處置procedure, 衛材material, 檢驗laboratory, 病理pathology, 醫囑order/費用fee (NHI Fee Schedule)
(5)研究對象排除條件 (Exclusion criteria) *
e.g. 用以下條件篩選: 診斷diagnosis (ICD9-CM, ICD-10) , 藥品medication (ATC), 處置procedure, 衛材material, 檢驗laboratory, 病理pathology, 醫囑order/費用fee (NHI Fee Schedule)
(6)介入Intervention / 暴露Exposure (I)
e.g. 用以下條件定義: 診斷diagnosis (ICD9-CM, ICD-10) , 藥品medication (ATC), 處置procedure, 衛材material, 檢驗laboratory, 病理pathology, 醫囑order/費用fee (NHI Fee Schedule)
(7)比較Comparator (C)
e.g. 用以下條件定義: 診斷diagnosis (ICD9-CM, ICD-10) , 藥品medication (ATC), 處置procedure, 衛材material, 檢驗laboratory, 病理pathology, 醫囑order/費用fee (NHI Fee Schedule)
(8)結果Outcome (O)
e.g. 用以下條件定義: 診斷diagnosis (ICD9-CM, ICD-10) , 藥品medication (ATC), 處置procedure, 衛材material, 檢驗laboratory, 病理pathology, 醫囑order/費用fee (NHI Fee Schedule)
*依據以上PICOTS定義,會初步提供近一年三院樣本數供參(for IRB),需7-10個工作天。Based on the above PICOTS definition, samples from the three hospitals over the last year will be initially provided for reference (for IRB), and will require 7-10 working days.
*若您已提交研究資料庫申請單,欲申請釋出資料(data to go),敬請您於"建議或回饋Suggestion or feedback"填上申請案案號。If you have already apply the APP02 and want to apply data to go, please write the case number from APP02 on the suggestion or feedback.
(9)干擾Confounding
e.g. age, sex, comorbidity, complication, medication, surgery, medication history…
(10)研究設計Study design (S)
(11)統計方法Statistical methods
主要參考文獻Reference (1~5篇)
建議或回饋Suggestion or feedback
若您已提交研究資料庫申請單,欲申請釋出資料(data to go),敬請您於此處填上申請案案號。填e-mail會將結果一併寄出。If you have already apply the APP02 and want to apply data to go, please write the case number from APP02 on the suggestion or feedback.
個人資料提供告知暨說明書 Notice and instructions for providing personal information
個人資料提供告知暨同意書財團法人臺北醫學大學(以下簡稱本校)依個人資料保護法之相關規定,將對您個人資料進行蒐集、處理或利用,依法告知您以下事項,為保障您的權益,請詳細閱讀本同意書所有內容。當您簽署本同意書時,表示您已閱讀、瞭解並同意接受本同意書之所有內容及其後修改變更規定 。本同意書之所有內容及其後修改變更規定,規範詳述如下:
1.資料來源:臺北醫學大學
2.蒐集目的:執行諮詢案進度追蹤之管理需求。
3.蒐集個人資料類別及範圍:申請者單位、姓名、電話、E-mail。
4.個人資料使用期間:諮詢案申請日至結案日。
5.您瞭解此一同意書符合個人資料保護法及相關法規之要求,具有書面同意本校蒐集、處理及利用您的個人資料之效果,且同意本校留存此同意書,供日後取出查驗。
6.個人資料之權利及權益:您依法得行使個人資料保護法第 3條之個人權利,但因本校執行職務或業務所必須者,本校得拒絕之。權利之行使方式請洽本校各單位聯絡窗口。若因您行使上述權利,而導致權益受損時,本校將不負相關賠償責任。
7.本校保留隨時修改本同意書規範之權利,本校將於修改規範時,將於本校網頁公告修改之事實,不另作個別通知。如果您不同意修改的內容,請主動通知本校,否則將視為您已同意並接受本規範該等增訂或修改內容之拘束。
8.本同意書之解釋與適用,以及本同意書有關之爭議,均應依照中華民國法律予以處理,並以台灣臺北地方法院為管轄法院。

Notification and Consent Form for Providing Personal Information. In accordance with the relevant provisions of the Personal Data Protection Act, Taipei Medical University (hereinafter referred to as TMU) shall inform you of the following when collecting, processing or using your personal data as required by the law. To ensure your rights and interests, please read all the contents of this consent form in detail. Signing this consent form means that you have read, understood and agreed to accept all the contents of this consent form and subsequent amendments and changes. The terms of all the contents of this consent form and its subsequent amendments and changes are detailed as follows:
1. Data source: Taipei Medical University
2. Purpose of collection: Management requirements for tracking the progress of applications.
3. Category and scope of personal data collected: Applicant's department, name, telephone number and E-mail.
4. Personal data period of use: From the application date to the closing date of the case.
5. You understand that this consent form complies with the requirements of the Personal Data Protection Act and relevant regulations, which effectively gives written consent to TMU to collect, process and use your personal data, and you also consent to TMU retaining this consent form for future inspection.
6. Personal data rights and interests: You may exercise your personal rights in accordance with Article III of the Personal Data Protection Act. However, TMU may refuse to oblige if it is necessary for executing its duties or tasks. Please enquire with the contact person of the relevant TMU unit regarding your exercise of rights. If your rights are undermined as a result of exercising the abovementioned rights, TMU shall not be liable for compensation.
7. TMU shall reserve the right to revise the terms of this consent form at any time. When the terms are revised, TMU shall announce the revision on the TMU webpage and shall not issue separate notifications. If you do not agree to the revised content, please take the initiative to notify TMU. Otherwise, you shall be regarded as having agreed to and accepted the restrictions of the new or revised content of the terms.
8. Taiwan Taipei District Court shall be the court of jurisdiction for the interpretation and application of this consent form and disputes related to this consent form, and this consent form shall be governed by the laws of the Republic of China.

請確認: *
PICOTS QRcode
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