Terms of Reference / Standard Operating Procedure
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
Chapter 7: Site Monitoring
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]
Glossary
