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| playground:what_are_the_registration_instructions_for_an_irb [2025/01/23 20:00] – created aldens | playground:what_are_the_registration_instructions_for_an_irb [2025/01/24 01:33] (current) – removed aldens |
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| Registration process for an IRB | |
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| Provide some links and details that further explain the BPMN that will be added below. | |
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| This is stuff that I need should take out and explain outside the BPMN model flowchart: | |
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| If IORG is not known, search for your institution or organization on the OHRP website at http://ohrp.cit.nih.gov/search/search.aspx?styp=bsc or contact OHRP using the contact information at https://www.hhs.gov/ohrp/about-ohrp/contact-us/index.html#go-to-fwa-irb-inquiries or by phone at 1-866-447-4777. | |
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| IRB Roster form is required if the IRB is designated on a Federal-wide assurance submitted to OHRP. | |
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| <bpmnio type="bpmn"> | |
| <?xml version="1.0" encoding="UTF-8"?> | |
| <definitions xmlns="http://www.omg.org/spec/BPMN/20100524/MODEL" xmlns:bpmndi="http://www.omg.org/spec/BPMN/20100524/DI" xmlns:dc="http://www.omg.org/spec/DD/20100524/DC" xmlns:di="http://www.omg.org/spec/DD/20100524/DI" id="definitions_1"><process id="Process_1" isExecutable="false"><startEvent id="start"><outgoing>start-gateway1</outgoing></startEvent><exclusiveGateway id="gateway1" name="Has your institution or organization previously registered an IRB with HHS?"><incoming>start-gateway1</incoming><outgoing>gateway1-taskIORG</outgoing><outgoing>gateway1-taskInstitutionName</outgoing></exclusiveGateway><userTask id="taskIORG" name="What is your IORG number?"><incoming>gateway1-taskIORG</incoming><outgoing>taskIORG-taskSeniorOfficer</outgoing><outgoing>taskIORG-taskSeniorOfficer</outgoing></userTask><userTask id="taskInstitutionName" name="Name of Institution or Organization operating the IRB(s)"><incoming>gateway1-taskInstitutionName</incoming><outgoing>taskInstitutionName-taskAddress</outgoing></userTask><userTask id="taskAddress" name="Provide the full legal name of the institution or organization that is operating the IRB(s) being registered and full mailing address, including country if outside the United States."><incoming>taskInstitutionName-taskAddress</incoming><outgoing>taskAddress-taskSeniorOfficer</outgoing><outgoing>taskAddress-taskSeniorOfficer</outgoing></userTask><userTask id="taskSeniorOfficer" name="Senior Officer or Head Official responsible for overseeing the activities of the IRB(s)"><incoming>taskIORG-taskSeniorOfficer</incoming><incoming>taskIORG-taskSeniorOfficer</incoming><incoming>taskAddress-taskSeniorOfficer</incoming><incoming>taskAddress-taskSeniorOfficer</incoming><outgoing>taskSeniorOfficer-taskContactPerson</outgoing></userTask><userTask id="taskContactPerson" name="Contact person providing this registration information"><incoming>taskSeniorOfficer-taskContactPerson</incoming><outgoing>taskContactPerson-taskIRBRegistrationInfo</outgoing></userTask><userTask id="taskIRBRegistrationInfo" name="IRB Registration Information (needs to be completed separately for each IRB being renewed, updated, or registered)"><incoming>taskContactPerson-taskIRBRegistrationInfo</incoming><outgoing>taskIRBRegistrationInfo-taskIRBName</outgoing></userTask><userTask id="taskIRBName" name="Provide the IRB Name, if any, that has been assigned by your institution or organization"><incoming>taskIRBRegistrationInfo-taskIRBName</incoming><outgoing>taskIRBName-gatewayOHRP</outgoing></userTask><exclusiveGateway id="gatewayOHRP" name="Is the IRB regulated by OHRP?"><incoming>taskIRBName-gatewayOHRP</incoming><outgoing>gatewayOHRP-taskOHRPInfo</outgoing><outgoing>Flow_13qsgrt</outgoing></exclusiveGateway><userTask id="taskOHRPInfo" name="Provide the approximate number of full time equivalent positions devoted to this IRB’s administrative activities, provide the approximate number of all active protocols"><incoming>gatewayOHRP-taskOHRPInfo</incoming><outgoing>taskOHRPInfo-gatewayFDA</outgoing><outgoing>Flow_0a8ykr6</outgoing></userTask><exclusiveGateway id="gatewayFDA" name="Is the IRB regulated by the FDA?" default="Flow_0k1s50w"><incoming>taskOHRPInfo-gatewayFDA</incoming><outgoing>gatewayFDA-taskFDAInfo</outgoing><outgoing>Flow_1cz5em2</outgoing></exclusiveGateway><userTask id="taskFDAInfo" name="Provide the approximate number of active protocols involving FDA-regulated products"><incoming>gatewayFDA-taskFDAInfo</incoming><outgoing>taskFDAInfo-taskIRBChair</outgoing></userTask><userTask id="taskIRBChair" name="Provide the IRB chairperson's full name, phone number, and email address"><incoming>taskFDAInfo-taskIRBChair</incoming><incoming>Flow_0a8ykr6</incoming><incoming>Flow_13qsgrt</incoming><incoming>Flow_1cz5em2</incoming><outgoing>taskIRBChair-taskIRBForm</outgoing></userTask><userTask id="taskIRBForm" name="Complete IRB Roster Form if required"><incoming>taskIRBChair-taskIRBForm</incoming><outgoing>taskIRBForm-end</outgoing></userTask><endEvent id="end"><incoming>taskIRBForm-end</incoming></endEvent><sequenceFlow id="start-gateway1" |
