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This Concept Map, created with IHMC CmapTools, has information related to: Phase 3 - Cooperative Group041711.cmap, Group Desease Committee (GDC) does not approve Next Steps?, FDA and Industry (if appropriate) Submits Comments in 21 day Comment Clarification (30 Days of Concept Submission), Final Protocol approved Activation, Protocol Authoring (90 days) submitted to CTEP, Terminated Next Steps?, Industry Partner resolves issues and revise concepts (completed within 60 days) Final Concept, trial idea to Group Desease Committee (GDC), coordinated response on issues and revisions resolves issues and revise protocol (within an additional 90 days) Final Protocol, Final Protocol disapproved Terminated, trial idea to alternatively, PI submits Concept document, CTEP/DS-SSC PI/Group, PI/Group prepares protocol, Principal Investigator (PI) submits trial idea, CTEP provides Feedback (within 30 days), Industry Partner CTEP/DS-SSC, CTEP/DS-SSC coordinated response on issues and revisions, CTEP/DS-SSC provides Feedback, Disease-Specific Scientific Steering Committee (DS-SSC) Task Force approves PI, Feedback (within 30 days) resolves issues and revise protocol (within an additional 90 days) Final Protocol