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The unique nature of patient-reported outcome (PRO) measures presents unique challenges for translation. Regulators emphasise the importance of maintaining conceptual equivalence across all languages in multilingualand multinational trials, while…
In recent years, a myriad of software has revolutionised the translation sector. This article presents a series of translation tools commonly used in the translation industry, depicting their main features and the way they have transformed the…
In a follow-up to the excellent article from Douglas Fiebig on how to use your review cycle effectively, this issue presents an extremely insightful article from Diana Radovan on how to help reviewers to communicate better with writers. Diana…
With the growth of information technology over the past decade, digital identifiers have been introduced for the unique and stable identification of digital objects in cyberspace. Digital identifiers have applications in many contexts, including…
The complexity of modern-day clinical trials has propelled trial design from being a consideration to now becoming what some experts believe is a science in and of itself. The United States Food and Drug Administration (FDA) sees immense potential…
This article presents an overview of open access initiatives by researchers, journals, government bodies, and regulatory authorities. Open access initiatives are valuable to the scientific community and have increased the amount of clinical research…
Plagiarism damages the biomedical academic publication domain. Artificial intelligence (AI) is a rising hope in academic plagiarism hunting. However, new AI-based tools are available online to assist with plagiarising! This article presents…
The skill of giving and receiving feedback. Medical writing requires a wide array of scientific and technical skills, the so-called hard skills of our trade. This issue spotlights another set of skills that are often underestimated – the so-called “s…
The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…
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…
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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