STANDARD OPERATING PROCEDURES (SOP)
- Introduction
- 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
IR-EC DOWNLOADABLE FORMS
- Form 8.1 Application Form for Protocol Review
- Form 8.2 Conflict of Interest Statement (COI)
- 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 22.1 Study Termination Form
- Form 23.1 Final Report Form
- Form 31.1 Confidentiality Agreement Form (for Non IR-EC Members)
