Your search for "clinical study protocol" matched 14 page(s).
Showing results 1 to 10.
The characteristics of the clinical study protocol (CSP) are discussed with regard to (i) its structure and (ii) its development process. The benefits of medical-writing involvement into both aspects are highlighted. In particular, medical writers…
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…
Clinical trial protocols must provide a clear trial design to meet the study objectives. Medical writers must understand and be ready to review and discuss aspects of the trial design with the protocol development team, in order to write a clear and…
The clinical research landscape is gradually changing as we enter the era of big data. Big data sources are multiplying as existing sources collide to create expanded platforms that serve wider areas of expertise. Clinical study designs…
Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been…
Data disclosure requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) mandate that protocols be shared on designated clinical trial websites. As a visual medium, theinternet is transforming the way these…
Biostatisticians and medical writers are among the key people who develop important documents for clinical trials. These documents include clinical study protocols, statistical analysis plans, statistical outputs, and clinical study reports. This…
Medical writers are increasingly involved in designing and documenting overall plans in paediatric drug development, e.g. EU PIPs (Paediatric Investigation Plans) and individual components, e.g. protocols and study reports. It is essential to…
Impact of protocol amendments, bias and quality in industry-funded trials, and rethinking authorship criteria Amendments to clinical trial protocols are widespread, but can result in increased costs and delays in study implementation.
The growing need for drug safety documents When I first started in regulatory writing (over a decade ago now, how time flies when you’re a medical writer), the types of document that I would be involved in were typically clinical study reports,…
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.
Medical Writing is listed in the following indexes:
Deputy Managing Editor
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Medical Communications/Writing for Patients
My First Medical Writing
News from the EMA
Out on Our Own
Regulatory Public Disclosure
Teaching Medical Writing
The Crofter: Sustainable Communications
Lay out Designer