Downloadable Forms

SOP 1A: Selection and Appointment of Research Ethics Committee Members

• RERC Form 1A: Nominee Curriculum Vitae
• RERC Form 1B: RERC Member Terms of Reference
• RERC Form 1C: Confidentiality Agreement
• RERC Form 1D: Conflict of Interest Declaration

SOP 1B: Selection and Appointment of Research Ethics Review Panel Members

• RERC Form 1A: Nominee Curriculum Vitae
• RERC Form 1B: RERC Member Terms of Reference
• RERC Form 1C: Confidentiality Agreement
• RERC Form 1D: Conflict of Interest Declaration

SOP 1C: Formation of Research Ethics Review Panels

• RERC Form 1A: Nominee Curriculum Vitae

SOP 2: Designation of  RERC Officers

• RERC Form 2A: Appointment of Officers
• RERC Form 16A: Notice of a Meeting

SOP 3: Appointment of Consultants

• RERC Form 3A: Invitation Letter for Independent Consultant
• RERC Form 3B: Appointment Letter for Independent Consultant
• RERC Form 3C: Terms of Reference for Independent Consultant
• RERC Form 1C: Confidentiality Agreement
• RERC Form 1D: Conflict of Interest Declaration

SOP 4: Expedited Review

• RERC Form 4A: Research Project Assessment Form
• RERC Form 4B: Informed Consent Assessment Form
• RERC Form 20A: Notice of Review Results-Approved
• RERC Form 20B: Notice of Review Results-Modifications Required
• RERC Form 4F: Review Results

SOP 5: Full Review

• RERC Form 5A: Notification for Full Review
• RERC Form 4A: Project Assessment Form
• RERC Form 4B: Informed Consent Assessment Form
• RERC Form 20A: Notice of Review Results-Approved
• RERC Form 20B: Notice of Review Results-Modifications Required
• RERC Form 5B: Full Review Report Form
• RERC From 5C: Full Review Decision Guide

SOP 6: Management of Initial Submissions (Classification)

• RERC Form 6A: Application for Ethics Review
• RERC Form 6B: Classification of Review Form
• RERC Form 6C: Guidelines for Review Classification
• RERC Form 6D: Certificate of Exemption
• RERC Form 6E: Exemption Checklist
• RERC Form 6F: Notice of Expedited Review
• RERC Form 6G: Notice of Full Review
• RERC Form 6H: Endorsement Letter Template

SOP 7: Management of Resubmissions

• RERC Form 7A: Cover Letter for Resubmissions
• RERC Form 7B: Review of Resubmissions
• RERC Form 4F: Review Results
• RERC Form 20A: Notice of Review Results – Approved
• RERC Form 20B: Notice of Review Results – Modifications Required

SOP 8 Review of Progress Report

• RERC Form 8A: Progress Report
• RERC Form 8B: Progress Report Decision Letter
• RERC Form 8C: Progress Report Assessment Form

SOP 9 Review of Amendments

• RERC Form 9A: Amendment Request Form
• RERC Form 9B: Amendment Request Decision Letter
• RERC Form 9C: Amendment Request Assessment Form

SOP 10 Management of Research Deviation and Violation Report

• RERC Form 10A: Research Project Deviation/ Violation Report Form
• RERC Form 10B: Project Deviation Decision Letter

SOP 11 Review of Safety Reports (RNEs_SAEs)

• RERC Form 11A: Reportable Negative Events Form
• RERC Form 11B: Adverse-Events Form/ Serious Adverse Events Form
• RERC Form 11C: RNE/ SAE Decision Letter

SOP 12 Management of an Application for Continuing Review

• RERC Form 12A: Application for Continuing Review
• RERC Form 12B: Continuing Review Decision Letter
• RERC Form 12C: Continuing Review Results

SOP 13 Review of Final Report

• RERC Form 13A: Final Report Form
• RERC Form 13B: Final Report Decision Letter
• RERC Form 13C: Final Report Assessment Form
• RERC Form 4F: Review Results

SOP 14 Review of Early Termination Reports

• RERC Form 14A: Early Termination Report
• RERC Form 14B: Early Termination Decision Letter
• RERC Form 14C: Early Termination Assessment Form
• RERC Form 4F: Review Results

SOP 15 Management of Appeals

• RERC Form 15A: Decision Letter for Appeals
• RERC Form 17A: Meeting Agenda

SOP 25 Management of Queries and Complaints

• RERC Form 25A: Queries/ Complaints Form
• RERC Forms 25B: Queries/ Complaints Decision Letter
• RERC Form 21A: Logbook of Incoming Communications
• RERC Form 21B: Logbook of Outgoing Communications
• RERC Form 17A: Meeting Agenda

SOP 16 Preparing for a Meeting

• RERC Form 17A: Meeting Agenda
• RERC Form 16A: Notice of Meeting

SOP 17 Preparation of the Meeting Agenda

• RERC Form 17A: Meeting Agenda
• RERC Form 19A: Meeting Minutes

SOP 18A Conduct of Meetings

• RERC Form 17A: Meeting Agenda
• RERC Form 19A: Meeting Minutes

SOP 18B Conduct of RERP Meetings

• RERC Form 17A: Meeting Agenda
• RERC Form 19A: Meeting Minutes
• RERC Form 1C: Confidentiality Agreement

SOP 19 Preparation of the Meeting Minutes

• RERC Form 19A: Meeting Minutes

SOP 20 Communication on RERC and RERP Decisions

• RERC Form 20A: Notice of Review Results-Approved
• RERC Form 20B: Notice of Review Results-Modifications Required
• RERC Form 4F: Review Results
• RERC Form 5A: Notification Letter-Full Review
• RERC Form 5E: Full Review Report Form
• RERC Form 8B: Progress Report Decision Letter
• RERC Form 9B: Amendment Request Decision Letter
• RERC Form 10B: Project Deviation Decision Letter
• RERC Form 11C: RNE/ SAE Decision Letter
• RERC Form 12B: Continuing Review Decision Letter
• RERC Form 13B: Final Report Decision Letter
• RERC Form 14B: Early Termination Decision Letter
• RERC Form 15A: Decision Letter for Appeals

SOP 21 Managing Communications

• RERC Form 21A: Logbook of Incoming Communications
• RERC Form 21B: Logbook of Outgoing Communications

• Appendix A:  Qualifications of RERC and RERP Members
• Appendix B: Duties and Responsibilities of RERC and RERP Members
• Appendix B: Qualifications of RERC and RERP Members
• RERC Form 1A: RERC Nominee Curriculum Vitae

SOP 22 Management of Active Files

• RERC Form 22A Research Project Folder Index

SOP 23 Archiving of Terminated, Inactive, and Completed Files

• RERC Form 17A: Meeting Agenda

SOP 24 Management of Access to Confidential Files

• RERC Form 24A: Request for Access to Confidential Files

SOP 26: Writing and Revising SOPs

• RERC Form 26A – SOP Template

SOP 26: Writing and Revising SOPs

• RERC Form 26A – SOP Template