Ethics Committee Registration
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| 01 |
CDSCO |
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Ethics Committee SOP Version 3
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History of SOP |
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| 01 |
Preparation of Standard Operating Procedures for SMVMCH Ethics Committee |
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| 02 |
Constitution of SMVMCH Ethics Committee (EC), Selection, Roles and Responsibilities of Members of the EC |
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| 03 |
Handling Conflict of Interest among Ethics Committee Members |
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| 04 |
Selection and Responsibilities of Independent Consultants |
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| 05 |
Procedures for allowing Guest/ Observer to visit Sri Manakula Vinayagar Medical College and Hospital Ethics Committee (SMVMCH-EC) or attend EC meeting |
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| 06 |
Management of Submission of Research Study Protocol and Study Related Documents |
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| 07 |
Categorization of New Research Study Protocols Received for Initial Review |
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| 07 A |
Initial Full Board Review of New Research Study Protocols |
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| 07 B |
Expedited Review of Research Study Protocols |
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| 07 C |
Exemption from ethics review of research study protocols |
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| 08 |
Agenda Preparation, Meeting Procedures and Recording of Minutes |
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| 09 |
Review of Resubmitted and Amended Protocols and Protocol-related Documents |
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| 10 |
Continuing Review of Study Protocols |
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| 11 |
Review of Protocol Deviations / Violations |
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| 12 |
Review of Serious Adverse Event (SAE) Reports |
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| 13 |
Review of Study Completion reports |
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| 14 |
Management of Premature Termination / Suspension / Discontinuation of the study |
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| 15 |
Waiver of written / verbal informed consent |
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| 16 |
Site Monitoring and Post-Monitoring Activities |
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| 17 |
Dealing with participants requests and/or Complaints to Institutional Ethics Committee |
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| 18 |
Maintenance of active study files, Administrative records of the ethics committee, Archival of closed files and retrieval of documents |
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| 19 |
Reviewing Proposals Involving Vulnerable Populations |
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| 20 |
Preparing for Ethics Committee Audit/ Inspection |
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| 21 |
Training and Assessment of Ethics Committee Members |
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| 22 |
To Review Biomedical & Health Research during COVID-19 Pandemic |
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