Overview of Changes for Committee Members
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"Facilitated Review (DO NOT SELECT - UNDER CONSTRUCTION) (DO NOT SELECT - UNDER CONSTRUCTION) ONLY for studies that have already been approved by the NIH NCI Central IRB." |
"Facilitated Review Use ONLY for studies to be conducted under joint oversight of the NIH NCI Central IRB (CIRB) and IRBMED. Click here for more information" The click here for more information text includes a link to a new help page. |
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FDA IND Documentation/Investigator's Brochure: For an investigator-sponsored IND (an IND submitted to the FDA by a University investigator), submit a copy of the IND application and subsequent FDA correspondence, including any amendments. For a manufacturer-sponsored IND, submit copies of the manufacturer's investigator's brochure or comparable document. |
FDA IND Documentation/Investigator's Brochure: For an investigator-sponsored IND (an IND submitted to the FDA by a University investigator), submit a copy of the IND application and subsequent FDA correspondence, including any amendments. For a manufacturer-sponsored IND, submit copies of the manufacturer's investigator's brochure or comparable document. Upload IND safety reports not included in the investigator's brochure. |
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"Affirm that the EXPECTEDNESS will be assigned for each adverse event according to the following definitions: Unexpected adverse events (i.e., NOT included in the informed consent document) Expected adverse events (i.e., included in the informed consent document)" |
"Affirm that the EXPECTEDNESS will be assigned for each adverse event according to the following definitions: Unexpected adverse events (i.e., has NOT been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation) Expected adverse events (i.e., has been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation)" |
New Application Documents tab: - Shared supporting documents - Internal supporting documents - Historical documents New Application, Manage Documents activity form - IRB-approved documents - Shared supporting documents - Internal supporting documents - Historical documents New Application, Ancillary Manage documents activity form Reviewer checklist form, supporting documents
Amendment Documents tab: - Supporting Documents uploaded by core staff Amendment, Manage Documents activity form - IRB-approved documents - supporting documents Amendment, Ancillary Manage documents activity form Meeting - Edit Discussion Items Activity Form - Workspace, Agenda Discussion Items detail page