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

Related documents and notice

​​SUBJECTS​​​LINKS/ DOWNLOAD DOCUMENTS
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)​

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