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Medical writers maintain a fine balance between data transparency obligations and personal data protection in clinical reports. Hence, we must stay informed of data protection requirements outlined in the EU General Data Protection Regulation (GDPR)…
The Clinical Trials Regulation (EU) No 536/2014 (CTR) came in force on January 31, 2022, specifying requirements for performing clinical trials in the EU and the European Economic Area (EEA). The CTR and the Clinical Trials Information System (CTIS)…
With scientific advances during the COVID- 19 pandemic and expansion of artificial intelligence (AI) in research, there has been a simultaneous increase in misinformation about data collection, privacy, and sharing in clinical trials. This increase h…
Current practice requires clinical and regulatory documents to be created and updated manually by medical writers throughout a product’s development. Conventionally, document content is unstructured, with freeform text, figures, and tables that the…
Clinical trial transparency is beneficial for patients, researchers, and the general public. However, rapidly evolving regulatory requirements for transparency have increased the information that will be published. Medical writers can play a key…
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…
Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…
The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…
Uri Kartoun (PhD in robotics, Ben Gurion University of the Negev, Israel) is a Staff Research Scientist and an IBM Master Inventor, co-developer of technologies such as MELD-Plus, EMRBots, Memory-memory (M2) Authentication, and Subpopulation-based…
CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…
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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