In May 2016 at the Munich conference the European Medical Writers Association (EMWA) announced the publication of the latest version of the Clarity and Openness in Reporting: E3-based (CORE) Reference user manual developed in collaboration with the American Medical Writers Association (AMWA).
The CORE Reference manual is aimed to help medical writers develop clinical study reports based on the ICH E3 Guideline: Structure and Content of Clinical Study Reports, which is applicable in the Russian Federation. It has been more than 20 years since the publication of the guideline. The regulatory and clinical trial environment has been developed actively. Clinical trial result transparency became a priority for international regulatory agencies. Today, the development of clinical study reports tends to be more and more complicated process. The CORE Reference is a useful and efficient tool as it summarizes the ICH E3 and EU legislative requirements on data transparency in one document. It also incorporates recommendations and advice of EMWA and AMWA members about the structure and content of different parts of a clinical study report.
OCT team joined the CORE Reference and uses its recommendations in practice by incorporating them into the company’s internal standard operating procedures. OCT medical writer Eugenia Radkova made a presentation about this new tool at the conference “Clinical Trials In and Outside Russia”.
At the recent AMWA conference in Denver (October 5-8), the company’s representatives announced the support of CORE Reference project by Russian medical writers. The essential role of this tool is also recognized by ICON Clinical Research, Clinipace Worldwide, Trilogy Writing and many other companies. Visit the project website to get more information about CORE Reference.
OCT employs the region’s largest team of medical writing experts who are members of AMWA and EMWA, and who always strive for improvement.