​​​​​​​CHAPTER 2 - ​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​APPLY FOR THE RESEARCH ETHICS COMMITTEE REVIEW

Related documents and notice

1General Information of Applying for REC ReviewPDF (Chinese)
2REC Review Fee List​link to REC Office (Chinese)​
3Full-Board Review
(1) SOP : REC SOP for Full Board Review ​​​​​PDF
​(2) Application Form
​    A. ​REC Clinical Trial/ Research Application Form​PDF
​    B. ​Investigator Self-Assessment Form for Clinical Research Application ​PDF​
​(3) Review Focus : ​REC Reviewer Checklist​​PDF
​(4) Download Documents
​    A. Investigation Drugs Clinical Trial
​        。Overseas approval data of international multiple sites drug clinical trial​PDF​ (Chinese)
​        。Investigation Drug ​Data​ SheetPDF​ (Chinese)
​        API Data Sheet​ (for Non-Primary Ingredient Plant)PDF​ (Chinese)
    B. Medical Device/ Technology​
                 。​Guide for Medical Device Clinical Trial​PDF (Chinese)
​        。New Medical Device & Technology Self-Assessment Form (for TFDA)PDF (Chinese)​
    C. Protection of Vulnerable Groups in Research
​        。Enrollment of  Vulnerable Groups​ Description Form​​link to REC Office​ (Chinese)
​        。REC Reviewer Checklist for Vulnerable Groups
             .Pregnant Women or FetusesPDF
   ​          .ChildrenPDF
             .​Neonates of Uncertain Viability​​PDF
​             .Nonviable Neonates​PDF​
​             .Adult with Diminished CapacityP​DF​​​ (Chinese)
​​​             .​Prisoners PDF​
    D. Informed Consent 
        。REC Guidelines for Informed Consent Process​PDF​
        。Informed Consent Form Template​​​PDF
​        。Informed Consent Form Template for Survey​PDF​
​        。Documentation Template for Consent ProcessP​DF​
    E. Data Safety Monitoring Plan (DSMP) 
​​​        。SOP : REC SOP for Data and Safety Monitoring​PDF​
​​​        。REC Form for Data & Safety Monitoring Plan ​PDF
    F. Conflict of Interest (COI)    
​        。SOP : REC SOP for COI Research Involving Human ParticipantsPDF
    ​    。Conflict of Interest Disclosure Form​PDF​
        。​Conflict of Interest ​Assessment and Disposal Plan Description FormPDF​ (Chinese)​
​​    G. Checklist for Trial/Research ​​Dominated by US FDAPDF (Chinese)
4Expedited Review​​​
​(1) SOP : REC SOP for Expedited Review​​PDF
(2) Application Form : REC Expedited Review Checklist for Clinical Research ​PDF
​(3) Review Focus : REC Reviewer Checklist​P​DF
(4) Download Documents​​link to REC Office (Chinese)​​
5Exempt Review​​
(1) SOP : REC SOP for Exempt Review​PDF
​(2) Application Form :  REC Clinical Trial/Research Exempt Review Application Formlink to REC Office (Chinese)​​​
​(3) Review Focus : REC Reviewer Checklist for Exempt ReviewPDF
​(4) Download Documents​link to REC Office (Chinese)​
6Other Information
​​​​ (1) Transnational Research & Multi-site Clinical Trials
     A. SOPREC Review of NTUH Investigator-led Transnational Research & Multi-site Clinical TrialsPDF
​​​     B. Description FormPDF​ (Chinese)
 (2) ​​Guideline for Internet ResearchPDF (Chinese)
 (3) Review Principle of the Gene Research​PDF (Chinese)
 (4) Suggested Content for Affidavit​​​​PDF (Chinese)
 (5) The Most Common ​Reviewer's Comments​​PDF​ (Chinese)​


Copyright 2015 © National Taiwan University Hospital. All Rights Reserved.​
The Materials on this Site are protected by copyright and/or other intellectual property laws and any unauthorized use of the Materials at this Site may violate such laws. Except as specifically permitted herein, no portion of the Materials on this Site may be copied, photocopied, reproduced, translated or reduced​ to any form or by any means without the prior written permission of National Taiwan University Hospital​​.​​​