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Both the federal Plain Writing Act and the mission of the US Centers for Disease Control and Prevention (CDC) to protect and promote people's health require CDC to communicate clearly so that people can understand and act on the important health…
This article discusses the challenges and quality assurance measures implemented by the authors when translating medical reports. In particular, the authors discuss the challenges posed by acronyms, handwritten and scanned text, and desktop…
Background: The European Union Clinical Trials Regulation 536/2014 (EU CTR) requires sponsors to submit summaries of clinical trial results in plain/lay language (Plain Language Trial Summaries [PLTS]). A multidisciplinary working group developed…
The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of…
Community and networking activity can really help when you are a freelancer. Who do you turn to when it all gets too much? Can someone, anyone, who understands your challenges, offer a sympathetic ear and help to work out a solution? Where do…
While there is ultimately no “secret sauce” to mentoring, in this article I outline my nonnegotiables, which, although not rocket science, often take the mentor’s concerted effort to implement. Firstly, everyone is different. While hardly…
The vast majority of investigator brochures lack sufficient information to systematically appraise the strength of the supporting pre clinical findings
Preparing clear, convincing scientific manuscripts is a challenge. In my experience, the biggest problem for most writers is not an inability to write well in English but rather a lack of clarity regarding what their article is supposed to be about.…
Abstract Clinical evaluation is a structured ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. The clinical data include current knowledge of the condition to be treated, published literature about the…
Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.
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