Press Release (ePRNews.com) - NEW YORK, NY - Oct 27, 2016 - The CORE Reference recommendations are aimed to help medical writers develop clinical reports based on requirements of the ICH E3 guidance ‘Structure and Content of Clinical Study Reports’, which are applicable in the Russian Federation. Over 20 years passed from the time it was published and the regulatory environment and clinical trials industry has been actively developing.
Providing an open access to clinical trials results became one of the prioritized activities of the foreign regulatory authorities. Under current conditions report development appears to get more and more complex. The CORE Reference recommendations present a useful and efficient tool, as it summarizes the ICH E3 requirements as well as legislative statements on data openness in one document. It also includes the recommendations and advice made by the EMWA and AMWA specialists about the structure and content of different parts of clinical trial report.
We have found CORE Reference to be very useful and essential for work and we are currently in the process of incorporating its principles and recommendations in our internal standards and procedures. We are also pleased to announce that we have shared information about CORE Reference at the IV annual conference held by OCT “Clinical trials in and outside Russia” that took place in Moscow on the 14th of September 2016. We hope this will help distribute CORE Reference in Russia.
OCT team joined the CORE Reference project and is implementing its recommendations into internal standard operating procedures. OCT medical writer Eugenia Radkova made a presentation about this new tool at the ‘Clinical trials in and outside Russia’ conference.
On October 5-8, AMWA held a conference, where it announced support of the CORE Reference project by Russian medical writers. The essential role of the tool is also acknowledged by such companies as ICON Clinical Research, Clinipace Worldwide, Trilogy Writing and many others. The additional information is available on the site of the project.
OCT is presented by the largest medical writers team among Russian contact research organizations. Our specialists are active members of the EMWA and AMWA. Source :