Framework: Post-trial, Continued Access Responsibilities to Investigational Medicines

The Post-trial, Continued Access Responsibilities to Investigational Medicines Framework: Scenarios that Require Further Consideration comprise 5 milestones, specific scenarios, and considerations that organizations can utilize to make equitable and fair decisions related to continued access to an investigational medicine. A framework for investigational significant risk devices is also available. The frameworks are designed to be used in coordination with the Principles of Post-Trial Responsibilities, a set of 12 grounding principles that identify the shared responsibilities of post-trial, continued access.