Your search for "reporting requirements" matched 79 page(s).
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Lay summaries of Phase I trials in healthy volunteers pose a challenge because their endpoints are complex, the targeted indication may not be known when they are conducted, their results are often reported years after the trial ended, and the…
For most of us, medical writing is highly technical. We prepare regulatory or clinical documents or write materials targeted to medical doctors. Medical writing for lay audiences is different, and it does not come naturally to most of us because…
We medical writers have a unique and valuable skill set, which includes, most notably, the ability to understand and clearly communicate complex medical information. We are also experts at working with multifunctional teams, compiling detailed…
Paper-based questionnaires are in widespread use for patient-reported outcomes, but they can be an inefficient way of collecting patient data. Electronic patient-reported outcomes are of wide interest and have the potential to drastically change…
Professor Matthias Rose is Medical Director of the Psychosomatic Department at the Charité University Hospital in Berlin, Germany. In this interview, I discuss with him patient-reported outcomes and the Patient-Reported Outcomes Measurement…
Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…
The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession?…
Academics who have transitioned to medical communications (MedComms) find that there are many parallels between the two fields, leading to fulfilling and rewarding careers. Many of the skills honed in academia such as research, technical writing,…
According to the final rule on “Clinical Trials Registration and Results Information Submission”, clinical trial protocols and statistical analysis plans have to be published on ClinicalTrials.gov. The requirement affects all applicable clinical…
Regulatory writing has various facets to it with good writing skills as a preliminary requirement. Well written reports form the basis of all regulatory submissions for marketing approval and its success largely depends on the research information…
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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