Medical Writing Post-Approval Regulatory Writing The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance
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Volume 23, Issue 4 - Post-Approval Regulatory Writing

The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance

Abstract

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the guidelines, and recent public disclosure requirements mean that review and revision of these guidelines is warranted. In May 2014, EMWA assembled a group of experts, called the Budapest Working Group (BWG), and initiated a 2-year collaboration with a variety of stakeholders to review the two guidelines. The resulting recommendations should address the needs of the widest possible community; incorporate developments since the guidelines were first issued; and facilitate responsible clinical trial data sharing. In this first of three planned open-access publications, we explain the objectives of this project, present our 2-year project plan, and report on progress to date.

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