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Spirituality of Compassion, Shepherding Leadership, Innovative Excellence, Superior  Expertise


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

             3.1  Types of Review

                 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

                 4.2  Review of Amendments

                 4.3  Review of SAEs and SUSARs

                 4.4  Review of Protocol Deviations / Violations

                 4.5  Review of Early Study Termination

Chapter 5:  Meetings

                 5.1  Preparation of Meeting Agenda and Conduct of Regular Meetings

                 5.2  Special 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

Chapter 9:  Writing and Revising SOPs




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