Ethics amendment clarification under review deadline
Bound the wait for clarification of an ethics amendment and prevent an unanswered query from being treated as approval. Editable collaboration with role lanes, decisions and an interrupting response timer. Illustrative policy and timing; adapt to local requirements.
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<?xml version="1.0" encoding="UTF-8"?>
<bpmn:definitions xmlns:bpmn="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" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" id="ethics_amendment_response_definitions" targetNamespace="urn:flowss:advanced">
<bpmn:message id="ethics_amendment_response_message" name="Amendment received"/>
<bpmn:process id="ethics_amendment_response_process" name="Ethics amendment clarification under review deadline" isExecutable="false">
<bpmn:documentation>Bound the wait for clarification of an ethics amendment and prevent an unanswered query from being treated as approval. Inputs: Amendment received. All policy choices, durations and conditions are illustrative. Replace example rules with approved local policy; configure integrations and review before execution. This non-executable template does not assert legal compliance or a real completed case.</bpmn:documentation>
<bpmn:laneSet id="ethics_amendment_response_lanes"><bpmn:lane id="ethics_amendment_response_lane_0" name="Ethics secretariat"><bpmn:flowNodeRef>ethics_amendment_response_start</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_intake_1</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_intake_2</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_wait</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_deadline</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_decision</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_success_1</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_success_rest_1</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_complete</bpmn:flowNodeRef></bpmn:lane><bpmn:lane id="ethics_amendment_response_lane_1" name="Protocol reviewer"><bpmn:flowNodeRef>ethics_amendment_response_checks_1</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_checks_2</bpmn:flowNodeRef></bpmn:lane><bpmn:lane id="ethics_amendment_response_lane_2" name="Committee chair"><bpmn:flowNodeRef>ethics_amendment_response_exception_entry</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_escalate</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_exception_1</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_exception_2</bpmn:flowNodeRef><bpmn:flowNodeRef>ethics_amendment_response_alternate</bpmn:flowNodeRef></bpmn:lane></bpmn:laneSet>
<bpmn:startEvent id="ethics_amendment_response_start" name="Amendment received"><bpmn:messageEventDefinition id="ethics_amendment_response_start_def" messageRef="ethics_amendment_response_message"/></bpmn:startEvent>
<bpmn:userTask id="ethics_amendment_response_intake_1" name="Register amendment version"></bpmn:userTask>
<bpmn:userTask id="ethics_amendment_response_intake_2" name="Send clarification request"></bpmn:userTask>
<bpmn:receiveTask id="ethics_amendment_response_wait" name="Await investigator clarification"></bpmn:receiveTask>
<bpmn:boundaryEvent id="ethics_amendment_response_deadline" name="Response deadline" attachedToRef="ethics_amendment_response_wait" cancelActivity="true"><bpmn:timerEventDefinition id="ethics_amendment_response_deadline_def"><bpmn:timeDuration xsi:type="bpmn:tFormalExpression">P14D</bpmn:timeDuration></bpmn:timerEventDefinition></bpmn:boundaryEvent>
<bpmn:userTask id="ethics_amendment_response_checks_1" name="Review amended safeguards"></bpmn:userTask>
<bpmn:userTask id="ethics_amendment_response_checks_2" name="Compare consent changes"></bpmn:userTask>
<bpmn:exclusiveGateway id="ethics_amendment_response_decision" name="Amendment acceptable?" default="ethics_amendment_response_flow_8"></bpmn:exclusiveGateway>
<bpmn:userTask id="ethics_amendment_response_success_1" name="Issue amendment approval"></bpmn:userTask>
<bpmn:exclusiveGateway id="ethics_amendment_response_exception_entry"></bpmn:exclusiveGateway>
<bpmn:userTask id="ethics_amendment_response_escalate" name="Escalate overdue case to owner"></bpmn:userTask>
<bpmn:userTask id="ethics_amendment_response_exception_1" name="Keep amendment on hold"></bpmn:userTask>
<bpmn:userTask id="ethics_amendment_response_exception_2" name="Notify investigator of required action"></bpmn:userTask>
<bpmn:endEvent id="ethics_amendment_response_alternate" name="Amendment held"></bpmn:endEvent>
<bpmn:userTask id="ethics_amendment_response_success_rest_1" name="Archive approved version"></bpmn:userTask>
<bpmn:endEvent id="ethics_amendment_response_complete" name="Amendment approved"></bpmn:endEvent>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_1" sourceRef="ethics_amendment_response_start" targetRef="ethics_amendment_response_intake_1"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_2" sourceRef="ethics_amendment_response_intake_1" targetRef="ethics_amendment_response_intake_2"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_3" sourceRef="ethics_amendment_response_intake_2" targetRef="ethics_amendment_response_wait"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_4" sourceRef="ethics_amendment_response_wait" targetRef="ethics_amendment_response_checks_1"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_5" sourceRef="ethics_amendment_response_checks_1" targetRef="ethics_amendment_response_checks_2"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_6" sourceRef="ethics_amendment_response_checks_2" targetRef="ethics_amendment_response_decision"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_7" sourceRef="ethics_amendment_response_decision" targetRef="ethics_amendment_response_success_1" name="Yes"><bpmn:conditionExpression xsi:type="bpmn:tFormalExpression">=amendmentAcceptable = true</bpmn:conditionExpression></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_8" sourceRef="ethics_amendment_response_decision" targetRef="ethics_amendment_response_exception_entry" name="Otherwise"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_9" sourceRef="ethics_amendment_response_deadline" targetRef="ethics_amendment_response_escalate"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_10" sourceRef="ethics_amendment_response_escalate" targetRef="ethics_amendment_response_exception_entry"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_11" sourceRef="ethics_amendment_response_exception_entry" targetRef="ethics_amendment_response_exception_1"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_12" sourceRef="ethics_amendment_response_exception_1" targetRef="ethics_amendment_response_exception_2"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_13" sourceRef="ethics_amendment_response_exception_2" targetRef="ethics_amendment_response_alternate"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_14" sourceRef="ethics_amendment_response_success_1" targetRef="ethics_amendment_response_success_rest_1"></bpmn:sequenceFlow>
<bpmn:sequenceFlow id="ethics_amendment_response_flow_15" sourceRef="ethics_amendment_response_success_rest_1" targetRef="ethics_amendment_response_complete"></bpmn:sequenceFlow>
</bpmn:process>
<bpmn:collaboration id="ethics_amendment_response_collaboration"><bpmn:participant id="ethics_amendment_response_party" name="Principal investigator"/><bpmn:participant id="ethics_amendment_response_pool" name="Ethics amendment clarification under review deadline" processRef="ethics_amendment_response_process"/><bpmn:messageFlow id="ethics_amendment_response_request" sourceRef="ethics_amendment_response_party" targetRef="ethics_amendment_response_start"/><bpmn:messageFlow id="ethics_amendment_response_response" sourceRef="ethics_amendment_response_party" targetRef="ethics_amendment_response_wait"/></bpmn:collaboration>
<bpmndi:BPMNDiagram id="ethics_amendment_response_diagram"><bpmndi:BPMNPlane id="ethics_amendment_response_plane" bpmnElement="ethics_amendment_response_collaboration">
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<bpmndi:BPMNShape id="ethics_amendment_response_lane_0_di" bpmnElement="ethics_amendment_response_lane_0" isHorizontal="true"><dc:Bounds x="50" y="180" width="2390" height="260"/></bpmndi:BPMNShape>
<bpmndi:BPMNShape id="ethics_amendment_response_lane_1_di" bpmnElement="ethics_amendment_response_lane_1" isHorizontal="true"><dc:Bounds x="50" y="440" width="2390" height="260"/></bpmndi:BPMNShape>
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<bpmndi:BPMNShape id="ethics_amendment_response_start_di" bpmnElement="ethics_amendment_response_start"><dc:Bounds x="162" y="292" width="36" height="36"/><bpmndi:BPMNLabel><dc:Bounds x="108" y="335" width="144" height="40"/></bpmndi:BPMNLabel></bpmndi:BPMNShape>
<bpmndi:BPMNShape id="ethics_amendment_response_intake_1_di" bpmnElement="ethics_amendment_response_intake_1"><dc:Bounds x="325" y="272" width="130" height="76"/></bpmndi:BPMNShape>
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<bpmndi:BPMNEdge id="ethics_amendment_response_flow_1_di" bpmnElement="ethics_amendment_response_flow_1"><di:waypoint x="198" y="310"/><di:waypoint x="325" y="310"/></bpmndi:BPMNEdge>
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