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SOPS and Forms

Standard Operating Procedures (SOP)

Introduction
SOP Table of Contents
SOP 1.0 Writing SOP
SOP 2.0 Revising or Updating SOP
SOP 3.0 Structure and Composition of the IR-EC Membership
SOP 4.0 Appointment of the IR-EC Members
SOP 5.0 Appointment of Independent Consultants
SOP 6.0 Training of IR-EC Members and Independent Consultants
SOP 7.0 Facilitating Compensation of IR-EC Members and Independent Consultants
SOP 8.0 Management of Initial Submissions Including Exemption from Review
SOP 9.0 Management of Expedited Review
SOP 10.0 Management of Full Review
SOP 11.0 Management of Protocols Undergoing Parallel DOH-SJREB Review
SOP 12.0 Management of Resubmission
SOP 13.0 Management of Appeals
SOP 14.0 Management of Protocols on Medical Device
SOP 15.0 Review of SAE
SOP 16.0 Review of Protocol Amendments
SOP 17.0 Review of Progress Reports
SOP 18.0 Review of Protocol Violation and Protocol Deviation
SOP 19.0 Management of an Application for Continuing Review
SOP 20.0 Management of Queries and Complaints
SOP 21.0 Site Visits
SOP 22.0 Review of Early Protocol Termination
SOP 23.0 Review of Final Reports
SOP 24.0 Preparing for a Meeting
SOP 25.0 Preparing for the Minutes of the Meeting
SOP 26.0 Conduct of Meetings
SOP 27.0 Communicating IR-EC Decision to Principal Investigator
SOP 28.0 Management of Active Study Files, Documents and Records
SOP 29.0 Management of Incoming and Outgoing Communication
SOP 30.0 Archiving of Inactive Files
SOP 31.0 Management of Access to Confidential Files
SOP References
SOP Annex 1 List of Acronyms and Glossary of Terms
SOP Annex 2 List of IR-EC Forms

IR-EC Downloadable Forms

Form 1.1 SOP Template
Form 1.2 SOP Proposal
Form 3.1 Letter of Appointment of IR-EC Member
Form 3.2 CV Form
Form 3.3 Performance Evaluation Tool for IR-EC Member
Form 3.4 Confidentiality and Conflict Interest Declaration
Form 4.1 Appointment Letter of Independent Consultants
Form 5.1 Training Record Form
Form 7.1 Application Form for Protocol Review
Form 7.2 Conflict of Interest Statement
Form 8.1 Checklist for Exemption from Ethical Review
Form 8.2 Certificate of Exemption
Form 10.1 Protocol Assessment
Form 10.2 Informed Consent Assessment Form
Form 10.3 Notice of Research Approval
Form 12.1 Protocol Resubmission Form
Form 15.1 Serious Adverse Event (SAE) Report
Form 15.2 Unexpected Event/Unanticipated Risk Report
Form 16.1 Protocol Amendment Review Form
Form 17.1 Progress Report
Form 18.1 Protocol Deviation and Violation Report Form
Form 19.1 Continuing Review Form
Form 20.1 Request/Query Record
Form 21.1 Site Visit
Form 22.1 Study Termination Form
Form 23.1 Final Report Form
Form 25.1 Minutes of the Meeting
Form 26.1 Notice of Meeting
Form 27.1 Decision Letter
Form 31.1 Confidentiality Agreement Form (for Non IR-EC Members)