
IERB - SOP/FORMS
Spirituality of Compassion, Shepherding Leadership, Innovative Excellence, Superior Expertise
TABLE OF CONTENTS
Chapter 1: IERB Structure and Composition
1.1 Selection and Appointment of Members
1.2 Designation of Officers and Responsibilities of Members
1.3 Appointment of Independent Consultants
1.4 Appointment of Alternate Members
1.5 Resignation or Removal of Members
1.6 Management of Conflict of Interest and Confidentiality
Chapter 2: Management of Initial Submission
Chapter 3: Types of Review and Review Procedures
3.2 Conduct of Expedited Review
3.3 Conduct of Full Board Review
Chapter 4: Post-Approval Submission
4.1 Review of Progress / Final Reports
4.4 Review of Protocol Deviations / Violations
4.5 Review of Early Study Termination
5.1 Preparation of Meeting Agenda and Conduct of Regular Meetings
Chapter 6: Management of Communications and Records
6.1 Preparation of Meeting Minutes
6.2 Communicating IERB Decisions and Management of Incoming / Outgoing Communications
6.3 Management of Active Files
6.4 Management of Non Active Files
6.5 Maintenance of Confidentiality of Study Files
Chapter 7: Management of Site Visits
Chapter 8: Management of Queries and Complaints
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