RELIANCE AGREEMENT REQUEST FORM Non-MetroHealth IRB to serve as IRB of Record/Reviewing IRB (Version: 02-12-2024)Reliance Agreement • February 12th, 2024
Contract Type FiledFebruary 12th, 2024INSTRUCTIONS AND INFORMATION for INITIAL SUBMISSION Review APPENDIX A TIP SHEET & Appendix D: eIRB Reliance Request submission checklist, for additional information. The following documents are to be submitted to the METROHEALTH IRB via eIRB: Reliance Agreement Request Form: Non-METROHEALTH IRB to serve as IRB of Record/Reviewing IRB This form should be completed to implement an agreement for METROHEALTH to rely on a Non-METROHEALTH IRB to serve as the IRB of Record (Reviewing IRB) for a single study or a group of studies. Requirements for any ancillary approvals (e.g., Scientific Review Committee, PRMC, Radiation Safety, Risk Assessment). Current version of the approved protocol document Original approval notice from the Reviewing IRB If applicable, most recent continuation approval notice from the Reviewing IRB If applicable, FDA correspondence for IND/IDE determination If applicable, Waiver of MetroHealth Pharmacy Investigational Drug Services (MPIDS): only required when the Met
RELIANCE AGREEMENT REQUEST FORM Non-MetroHealth IRB to serve as IRB of Record (Version: 02-12-2024)Reliance Agreement • February 12th, 2024
Contract Type FiledFebruary 12th, 2024INSTRUCTIONS AND INFORMATION for INITIAL SUBMISSION This form should be completed to implement an agreement for METROHEALTH to rely on a Non-METROHEALTH IRB to serve as the IRB of Record (Reviewing IRB) for a single study or a group of studies. The following documents are to be submitted to the METROHEALTH IRB via eIRB: [Note: Please use the eIRB Reliance Request submission checklist-Appendix C] Reliance Agreement Request Form: Non-METROHEALTH IRB to serve as IRB of Record/Reviewing IRB Requirements for any ancillary approvals (e.g., Scientific Review Committee, PRMC, Radiation Safety, Risk Assessment). Current version of the approved protocol document Original approval notice from the Reviewing IRB If applicable, most recent continuation approval notice from the Reviewing IRB If applicable, FDA correspondence for IND/IDE determination If applicable, Waiver of MetroHealth Pharmacy Investigational Drug Services (MPIDS): only required when the MetroHealth Research Pharmacy will NOT be us