Kaohsiung Armed Forces General Hospital Logo
Review Process

Standard Operating Procedures for the Human Research Ethics Committee

Information Management Team
373 views

Standard Operating Procedures

SOP001. Principles for Developing Standard Operating Procedures

SOP002. Composition of the Human Research Ethics Committee

SOP003. Education and Training of Committee Members

SOP004. Confidentiality and Conflict of Interest Avoidance Principles

SOP005. Management Procedure for Submitting Project Proposals for Review

SOP006. Ethical Training for Research Team

SOP007. Initial Review Procedure for New Cases

SOP008. Procedure for Exempt Review

SOP009. Simplified Review Procedure

SOP010. General Review Procedure

SOP011. Review Guidelines for Obtaining Informed Consent Process

SOP012. Review Principles for Waiving Informed Consent or Consent Forms

SOP013. Review Procedure for Re-review Cases

SOP014. Review Procedure for Project Amendment Cases

SOP015. Mid-term Report Review Procedure

SOP016. Final Report Review Procedure

SOP017. Invitation of Special Representative

SOP018. On-site Inspection Procedure for Project Cases

SOP019. Review Principles for Multi-center Research Project Cases

SOP020. Review Principles for Research Projects Outside the Institution

SOP021. Data and Safety Monitoring Plan

SOP022. Consultation and Counseling Procedures

SOP023. Procedure for Handling Trial Deviations

SOP024. Procedure for Handling Serious Adverse Event Occurrences

SOP025. Participant Consultation and Complaint Procedure

SOP026. Procedure for Suspension or Termination of Projects

SOP027. Emergency Meeting

SOP028. Meeting Notice, Procedure, and Minutes

SOP029. Preparation Procedure for Ethics Committee Audits

SOP030. Document Access and Archiving Procedures

SOP031. Review Procedure for Compassionate Use of Drugs

SOP032. Review and Management of Clinical Research Conflict of Interest

SOP033. Initial Review Procedure for Medical Devices


File Downloads

Download All