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CORE Reference - Clarity and Openness in Reporting: E3 based

Level:
Foundation
Area:
Drug Development
Code:
DDF38b
Duration:
03:30:00
Workshop profile:
Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of ICH reporting guidelines.
Objective:
The current ICH guidance on CSR authoring is ICH E3 (1995) and the 2012 Questions and Answers (Q & A) Revision document. Inconsistencies in interpretation require clarification, and indeed this is recognised specifically for ICH E3 in the 2012 Q & A document. CORE Reference (see http://www.core-reference.org/) launched on 03 May 2016, provides interpretational guidance on CSR authoring that incorporates regional (EU and US) and real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Participants will acquire the knowledge and skills required to author or review fit-for-purpose CSRs that belong in the modern drug development arena.
Content:
· Background to CORE Reference· Description of CORE Reference complete web-based resource · Common inconsistencies in ICH guideline interpretation and how CORE Reference addresses these issues · Background to transparency and public disclosure requirements · How CORE Reference deals with the challenges of responsible clinical trial data sharing.