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Aug 28, 2017
Post-Trial Responsibilities Framework Released
We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) .
This framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. An international multi-stakeholder workgroup, convened by the MRCT Center, developed this framework.
The foundation of this framework is summarized in 12 principles