Institutional Review Board
Chong Hua Hospital
 

Chapter 1 - IRB Structure and Composition
  1.1 - Ethical Framework and Constitution of the IRB
  1.2 - Selection of Independent Consultants
  1.3 - Training Personnel and Ethics Committee Members
  1.4 - Confidentiality or Conflict of Interest Agreement
  1.5 - Incentives for IRB Members and Consultants
Chapter 2 - Types of Review
  2.1 - Expedited Review
  2.2 - Full Board Review
Chapter 3 - Initial Review
  3.1 Management of Protocols Submissions
  3.2_Use of Study Assessment Form
  3.3._Review of Medical Device Study
Chapter 4 - Continuing Review
  4.1-REVIEW OF FINAL REPORT
  4.2-Study Protocol Amendment/a>
  
4.3-Review of Serious Adverse Event (SAE) Reports
  4.4-Management of Protocol Deviation and Violation
  4.5-Management of Study Termination
  4.6-SOP on Protocol Continuing Review
Chapter 5 - Meetings
  5.1-Preparation and Conduct of Meeting
  5.2-Emergency Meetings and other matters
Chapter 6 - Documentation and Management of Files and Archiving
  6.1 - Preparation of the Minutes of the IRB Meeting
  6.2 - Communicating IRB Decisions Incoming Outgoing Communications
  6.3 - Management of the Active Files
  6.4 - Archiving and Retrieval of Documents
  6.5 - Maintenance of Confidentiality of Study Files and IRB Documents
Chapter 7 - Site Monitoring Visits
  7.1 -Site Monitoring Visits
Chapter 8 - Response to Research Participants Request
  8.1 - Response to Research Participants Request
Chapter 9 - Writing and Revising SOPs
  9.1 - Writing, Reviewing, Distributing and Amending SOP for IRB
10 - Glossary

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