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The demand for greater transparency in financial relationships between the healthcare industry and healthcare professionals is increasing globally, and has led to establishing government regulations and professional guidelines for detailed reporting…
Bioanalytical reports are usually written by bioanalysts. Medical writers offer a valuable contribution to bioanalytical reporting, increasing the efficiency of document development and improving the quality of data presentation. This article…
At present, there are no specific requirements for the reporting of preclinical research, and many studies, particularly those with negative results, never get published. Despite the huge advances in communication opportunities, things have not…
Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in…
Several initiatives have been taken to standardise the reporting of animal studies in peer-reviewed scientific journals, such as the ARRIVE (Animal Research: Reporting of In Vivo Experiments) and GSPC (Gold Standard Publication Checklist)…
Sharing of deidentified/anonymised individual participant data is rapidly becoming the norm. The International Committee of Medical Journal Editors recently implemented requirements for data sharing as a condition for considering publication of…
The 2 year EMWA-AMWA CORE Reference project resulted in the publication of the open-access CORE Reference at http://www.core-reference.org on 03 May 2016. The full peer-reviewed publication supporting the launch of CORE Reference: Hamilton S,…
International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the…
A clinical investigation plan for a medical device must outline and justify all objectives of the clinical investigation, present and justify the investigational design and methodology, and state principal features of the statistical analysis. A…
The quest for transparency in the relationships between life sciences companies and healthcare professionals is quickly becoming a global movement. Reporting requirements for financial interactions have been prevalent in the United States for many…
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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