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The SOP establishes document management, committee formation and membership terms, chairperson nomination, expert invitation, and structured submission and checklists for new studies. 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Dated-------2022)\u003Cbr>ADDRESS: |  |  |\n\nINDEX  \n\n| SOP No | Standard Operating Procedure | Page No. | Addendum \\# | Name |\n| --- | --- | --- | --- | --- |\n|  |  |  | Effective from | Sign /date |\n|  | Preamble | 6 |  |  |\n| SOP-1 | Document Management for Standard Operating Procedure | 13 |  |  |\n|  |  |  |  |  |\n| Att. 1.3.1 | Template for Standard Operating Procedure | 16 |  |  |\n| Att. 1.3.2 | SOP Review and Revision Tracker | 18 |  |  |\n| Att. 1.3.3 | Template for Summary of Changes (Addendums) | 20 |  |  |\n| SOP –2 | Formation of the IEC and Terms of Reference for Membership | 22 |  |  |\n|  |  |  |  |  |\n| Att. 2.3.1 | List of Institutional Ethics Committee Clinical Studies Members | 30 |  |  |\n| Att. 2.3.2 | Honorarium Structure | 32 |  |  |\n| Att. 2.3.3 | Confidentiality and Conflict of Interest Undertaking ( Ethics Committee member) | 34 |  |  |\n| Att. 2.3.3.a | Confidentiality and Conflict of Interest Undertaking(Guest/Observer) | 37 |  |  |\n| Att. 2.3.4 | Delegation Log for Institutional Ethics Committee Secretariat personnel | 40 |  |  |\n| SOP–3 | Nomination of the Chairperson of Institutional Ethics Committee | 43 |  |  |\n|  |  |  |  |  |\n| SOP–4 | Changes in Membership of Institutional Ethics Committee | 45 |  |  |\n|  |  |  |  |  |\n| Att. 4.3.1 | List of Institutional Ethics Committee Members ( Revised) | 48 |  |  |\n| SOP –5 | Inviting a Subject Expert | 50 |  |  |\n|  |  |  |  |  |\n| Att. 5.3.1 | Confidentiality and Conflict of Interest |  |  |  |\n\n\n|  | Undertaking (Subject Expert) | 53 |  |  |\n| --- | --- | --- | --- | --- |\n| Att. 5.3.2 | Honorarium structure for Subject Expert | 56 |  |  |\n| SOP –6 | Submission of Documents for Review of New study | 58 |  |  |\n|  |  |  |  |  |\n| Att. 6.3.1.a | Documents Checklist for Clinical Studies | 62 |  |  |\n| Att. 6.3.1.b | Study Documents Checklist for DNB& Academic Proposals | 65 |  |  |\n| Att. 6.3.1.c | Study Documents Checklist for Biological Materials and Bio Banking | 67 |  |  |\n| Att. 6.3.1.d | Study Documents Checklist for Stem Cell Research | 69 |  |  |\n| Att. 6.3.2 | Institutional Ethics Committee Fees Structure | 71 |  |  |\n| Att. 6.3.3 | Checklist for Types of Review | 73 |  |  |\n| SOP – 7 | Review and Decision-Making Procedures | 75 |  |  |\n|  |  |  |  |  |\n| Att. 7.3.1 | Primary Review Form | 83 |  |  |\n| Att. 7.3.2 | Format for Conditional Approval Letter | 89 |  |  |\n| Att. 7.3.3 | Format for Final Approval Letter | 92 |  |  |\n| Att. 7.3.4 | Format for the Approval letter for DNB projects | 95 |  |  |\n| Att.7.3.5 | Format for Approval for Publication | 97 |  |  |\n| Att.7.3.6 | Template for Agenda/Minutes of Meeting | 100 |  |  |\n| Att.7.3.7 | Checklist for Clinical Trial Agreement review | 106 |  |  |\n| Att.7.3.8 | Format for Attendance and COI log | 109 |  |  |\n| SOP –8 | Continuing Review & Monitoring of Ongoing Studies. | 111 |  |  |\n\nINDEX  \n\n|  |  |  |  |  |\n| --- | --- | --- | --- | --- |\n| Att. 8.3.1 | Template for PI’s report on changes in the Amended Documents | 116 |  |  |\n| Att. 8.3.2 | Study Documents Amendments Tracking Log | 118 |  |  |\n| Att. 8.3.3 | Format for Study Completion/Close-out Report | 120 |  |  |\n| Att.8.3.4 | Format for Study Status/Progress Report | 123 |  |  |\n| Att. 8.3.5 | List of documents for re-approval | 125 |  |  |\n| Att.8.3.6 | Format for Re-Approval Letter | 127 |  |  |\n| Att.8.3.7 | Subject feedback and Redressal Form(Paper/ Electronic version) | 130 |  |  |\n| SOP –9 | Expedited Review Procedure | 133 |  |  |\n|  |  |  |  |  |\n| Att. 9.3.1 | Template for Expedited Approval Letter | 136 |  |  |\n| SOP –10 | Informed Consent | 139 |  |  |\n|  |  |  |  |  |\n| Att. 10.3.1 | Sample Consent Document in English | 145 |  |  |\n| Att.10.3.2 | ICD Review Form | 153 |  |  |\n| SOP –11 | Review of Research Involving Vulnerable Subjects | 156 |  |  |\n|  |  |  |  |  |\n| Att. 11.3.1 | List","cbCaihnyyNtHPx6j","https://ap.wps.com/l/cbCaihnyyNtHPx6j","pdf",18822865,196,"English","# Index\n## Preamble\n## SOP-1 Document Management for Standard Operating Procedure\n## SOP-2 Formation of the IEC and Terms of Reference for Membership\n## SOP-3 Nomination of the Chairperson of Institutional Ethics Committee\n## SOP-4 Changes in Membership of Institutional Ethics Committee\n## SOP-5 Inviting a Subject Expert\n## SOP-6 Submission of Documents for Review of New study\n## SOP-7 Review and Decision-Making Procedures\n## SOP-8 Continuing Review & Monitoring of Ongoing Studies\n## SOP-9 Expedited Review Procedure\n## SOP-10 Informed Consent\n## SOP-11 Review of Research Involving Vulnerable Subjects\n## SOP-12 Review of Serious Adverse Events (SAE)/Unanticipated problems\n## SOP-13 Change of Principal Investigator\n## SOP-14 Payment to Research Subjects\n## SOP-15 General Administration","[{\"question\":\"What is the purpose of the IEC-BMR Standard Operating Procedure at Apollo Hospitals?\",\"answer\":\"It defines how the Institutional Ethics Committee for Biomedical Research conducts and oversees biomedical research involving human subjects, ensuring due care and caution across all stages.\"},{\"question\":\"Which process does SOP-6 cover for starting a new study?\",\"answer\":\"SOP-6 covers submission of documents for review of a new study, including document checklist requirements and study document tracking for different study types.\"},{\"question\":\"How does the SOP handle ongoing studies and serious adverse events?\",\"answer\":\"SOP-8 provides continuing review and monitoring for ongoing studies, while SOP-12 sets procedures for review of serious adverse events (SAE) and unanticipated problems, supported by reporting templates and related regulations.\"}]","INSTITUTIONAL ETHICS COMMITTEE-BIOMEDICAL RESEARCH (IEC-BMR) - Standard Operating Procedure - Version AH-02 - 2022 | PDF",1789226896,69]