TABLE OF CONTENTS

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Chapter 1:  IERB Structure and Composition

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             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

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Chapter 2:  Management of Initial Submission

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Chapter 3:  Types of Review and Review Procedures

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             3.1  Types of Review

                 3.2  Conduct of Expedited Review

                 3.3  Conduct of Full Board Review

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Chapter 4:  Post-Approval Submission

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             4.1  Review of Progress / Final Reports

                 4.2  Review of Amendments

                 4.3  Review of SAEs and SUSARs

                 4.4  Review of Protocol Deviations / Violations

                 4.5  Review of Early Study Termination

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Chapter 5:  Meetings

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                 5.1  Preparation of Meeting Agenda and Conduct of Regular Meetings

                 5.2  Special Meetings

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Chapter 6:  Management of Communications and Records

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              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

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Chapter 7:  Management of Site Visits

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Chapter 8:  Management of Queries and Complaints

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Chapter 9:  Writing and Revising SOPs