1. Terms of Reference (ToR) of IRB [TOR Version_1.3]
2. STANDARD OPERATING PROCEDURES (SOPs) of IRB [Full Download]
3. CHAPTERWISE STANDARD OPERATING PROCEDURES (SOPs) of IRB:
Table of Contents: [TOC]
Chapter 1: Preparing Standard Operating Procedures (SOPs) & Guidelines for Review Board/ IRB
- 1.1: Writing, Reviewing, Distributing and Amending SOPs for Review Board [SOP/001/01]
- 1.2: Preparation of Guidelines [SOP/002/01]
Chapter 2: Constituting an Ethics Board/ Institutional Review Board (IRB)
- 2.1: Constituting an IRB [SOP/003/01]
- 2.2: Confidentiality /Conflict of Interest Agreements [SOP/004/01]
- 2.3: Training Personnel and IRB Members [SOP/005/01]
- 2.4: Selection of Independent Consultants [SOP/006/01]
Chapter 3: Initial Review Procedures
- 3.1: Determination of Research Qualifying from Exemption of Ethics Review [SOP/007/01]
- 3.2: Management of Protocol Submissions [SOP/008/01]
- 3.3: Expedited Reviews [SOP/009/01]
- 3.4: Initial Review of Research/ Application Protocols [SOP/010/01]
- 3.5: Review of New Medical Devices Studies [SOP/011/01]
- 3.6: Use of study Assessment Form [SOP/012/01]
Chapter 4: Protocol Amendments, Continuing Review & End of Study
- 4.1: Review of Resubmitted Protocols [SOP/013/01]
- 4.2: Review of Protocol Amendments [SOP/014/01]
- 4.3: Management of Protocol Continuing Reviews [SOP/015/01]
- 4.4: Review of Final Reports [SOP/016/01]
Chapter 5: Monitoring Protocol Implementation
- 5.1: Intervention in Protocol Deviation/Non-Compliance/Violation [SOP/017/01]
- 5.2: Response to Research Participants’ Request [SOP/018/01]
- 5.3: Management of Study Termination [SOP/019/01]
Chapter 6: Monitoring and Evaluation of Adverse Events
- 6.1: Review of Serious Adverse Events (SAE) Reports [SOP/020/01]
Chapter 7: Site Monitoring
- 7.1: Site Monitoring Visits [SOP/021/01]
Chapter 8: Preparation of Review Meeting Agenda and Communication Records
- 8.1: Agenda Preparation, Meeting Procedures and Minutes [SOP/022/01]
- 8.2: Emergency Meeting [SOP/023/01]
- 8.3: Communication Records [SOP/024/01]
Chapter 9: Managing Study Files
- 9.1: Maintenance of Active Study Files [SOP/025/01]
- 9.2: Archive and Retrieval of Documents [SOP/026/01]
- 9.3: Maintaining Confidentiality of IRB’s Documents [SOP/027/01]
Chapter 10: Evaluating an IEC/IRB
- 10.1: Audit and Inspection of the IRB [SOP/028/01]
Chapter 11: [Glossary]