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Institutional Ethics Review Board (IERB)
Vision, Mission, Objectives
Historical Background
IERB Board Members_2022-2024
Instructions and requirements
Flowchart of IERB Review Process
Review Fees
Schedule of meeting and cut-off date of submission
SOP
Cover Page
Table of Contents
Introduction
Accronyms and Terminologies
IERB Structure and Composition
Initial Review Procedures
IERB Monitoring Procedures
Documentation and Archiving
Writing and Revising Standard Operating Procedure
Reference
Appendix A Structure and Composition Forms
Appendix B Initial Review Procedures Forms
Appendix C Monitoring Procedures Forms
Appendix D Documentation and Archiving Forms
Appendix E IERB Fees
Appendix F Guidelines of Conduct of Clinical Trial During COVID-19 Pandemic
IERB forms
Document Receipt Form
Initial Review Application form
Resubmission Report Form
Continuing Review Form
Final Study Report Form
Deviation, Violation Reporting Form
Early termination, suspension of study form
SAE FORM
Amendment Aplication Form
References
2016 CIOMS
2019 ICH E6(R3) Guideline for Good Clinical Practice E6-R3_FinalConceptPaper
2020 PHREB SOP Workbook- PDF
2021 ICH_E6-R3_GCP-Principles
2021 SJREB SOP
2022 NEGRIHP_National Ethical Guidelines
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Last Modified: June 24, 2024