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SOP for Research Involving Human Subject

No
Tittle of SOP
File
1
Writing, Reviewing, Distributing and Amending Standard Operating Procedures for Ethics Committees
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2
Preparation of Guidelines
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3
Constituting an MRIN EC
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4
Confidentiality / Conflict of Interest Agreements
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5
Training Personnel and MRIN EC Members
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6
Selection of Independent Consultants
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7
Management of Protocol Submissions
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8
Use of Study Assessment Forms
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9
Expedited Review
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10
Initial Review of Submitted Protocols
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11
Review of New Medical Device Studies
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12
Review of Resubmitted Protocols
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13
Review of Protocol Amendments
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14
Continuing Review of Study Protocols
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15
Review of Final Reports
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16
Intervention in Protocol Deviation /Non-Compliance/Violation Intervention
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17
Response to Participants' Requests
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18
Management of Study Termination
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19
Review of Serious Adverse Events (SAE)/SUSAR Reports
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20
Site Monitoring Visit
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21
Agenda Preparation, Meeting Procedures and Minutes
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22
Emergency Meeting
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23
Communication Records
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24
Maintenance of Active Study Files
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25
Archive and Retrieval of Documents
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26
Maintaining Confidentiality of MRIN EC Documents
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27
Audit and Inspection of the MRIN EC
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