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On the heels of TransCelerate’s successful roll-out of the common protocol template (CPT), the organization’s common clinical study report (CSR) template was first publicly released in December 2018 and is being adopted across the industry. An updated technology-enabled version was publicly released December 2019 and CSR considerations for studies disrupted by the COVID-19 pandemic were released in May 2020. Learn the story behind this thoughtfully designed CSR template, including the collaborative development process and key decisions of the template design. Also discussed are how the template encourages adoption of a lean authoring approach, the advantages of the TransCelerate CSR template, and how to implement the template for the next CSR you write.
This webinar is based, in part, on the popular session at the 2019 AMWA Medical Writing & Communication Conference.
At the conclusion of this webinar, participants should be able to
·Discuss the collaborative approach that created this innovative CSR template based on best practices across the pharma industry
·Identify the advantages of the TransCelerate CSR template and structured authoring
·Implement the Common CSR template in the next CSR he or she writes
Learning Level: Regulatory writers of clinical study reports (CSRs) at all levels of experience
Content Areas: Regulatory writing, technology
About the Presenter
Elizabeth Brown, MS, PMP, is a Managing Medical Writer at Merck & Co, Inc. She started in the pharmaceutical industry nearly 2 decades ago as a laboratory scientist, continued into clinical research, and ultimately became one of the pioneering leaders of Merck’s Medical Writing department. She enjoys writing, managing, and leading teams to create efficient, effective, and quality documents. As a CSR SME and Lean Authoring expert, Elizabeth successfully led Merck’s CSR template redesign initiative. Building on the success of implementing this streamlined internal template, she was selected as Merck’s representative to the TransCelerate workstream tasked with developing the Common CSR Template.