​​​​​​​​​​​​​​​​​​​​​​​​CHAPTER 1 - PREPRATION

Things you need to know before starting a trial or research


SUBJECTS​​​​​
​​LINKS/ DOWNLOAD DOCUMENT​S
​1​The Responsibilities of Principle Investigator​
(1) Responsibility Statement of the Principal Investigator of NTUH REC Research​PDF
​(2) Responsibility Statement of the Investigator of Clinical TrialPDF
2Research Involving Human Participants​​​​​​​​​Introduction​
3The Qualification Requirements for NTUH Investigators​
(1) Qualification Requirements for NTUH InvestigatorsPDF​
(2) Training Requirements  for NTUH Investigators​link to description page
(3) Relevant laws and regulations: 
​​​     。ICH-GCP (E6)PDF​
     。Regulations for Good Clinical Practice​(Taiwan GCP)​link​​ to full text​
4Make A Perfect Protocol
(1) Investigation Drug Clinical Trial Protocol TemplatePDF​
(2) ​Biostatistics​ consultation​link to Clinical Trial Center​ (Chinese)
5Human Subjects Protection
(1) NTUH SOP: Code of Human Subjects Research Protection
​    。Code of Human Subjects Research Protection​PDF​
    。Operational Rules f​or Code of Human Subjects Research ProtectionPDF
(2) ​​REC Review Focus: ​REC Reviewer ChecklistPDF
(3) Investigator Self-Assessment Form for Clinical Research ApplicationPDF
(4) REC Policies on Recruitment, Advertisement and Payment in Human Subject Research​PDF
​(5) Privacy & Confidentiality​link to description page​
(6) How to protect human subject: For Researchers​link to HRP Center​ (Chinese)
6​Other Information
(1) Investigational Drug Management Service (Investigational Drug Management Center)​link to Clinical Trial Center (Chinese)
(2) Application for the Human Resources & Clinical Trial Specialized Ward and Interview Area​link to Clinical Trial Center (Chinese)
​​(3) Clinical Trial Registration
​    。Instruction of Clinical Trial Registration XML UploadPDF​ (Chinese)
    ​。Website : clinicaltrials.govlink to clinicaltrials.gov​
​​​​

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