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Lay Summaries in Clinical Trials: A Beginner’s Perspective on Making Research Understandable By ‘Femi Fajimi | 29/ April/2025 As a beginner regulatory medical writer, I am learning that writing clinical trial documents involves more than technical precision. Increasingly, regulatory requirements demand that clinical research results be communicated to the public in a clear, factual, and…
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Clinical Trial Protocols and Clinical Study Reports (CSRs): A Beginner’s Perspective By Femi Fajimi | 28 April 2025 As I continue developing my skills in regulatory medical writing, I am learning how essential two key documents are to the clinical trial lifecycle: the protocol and the clinical study report (CSR). Protocols define a study’s blueprint,…
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Investigator’s Brochure and Updates: A Beginner’s Guide By Femi Fajimi | 26 April 2025 When I first heard “Investigator’s Brochure,” I assumed it was a patient-facing document, perhaps a summary leaflet. However, I soon discovered that the IB is one of the most essential internal documents in a clinical trial. The Investigator’s Brochure (IB) is…
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Writing Patient Narratives in Clinical Trials: A Beginner’s Guide By Femi Fajimi | 22 April 2025 When I started exploring regulatory medical writing, one document type I kept coming across was the patient narrative. At first, I thought it would be a simple case summary, but I quickly discovered that writing a good narrative is…
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Starting Somewhere By Femi Fajimi | 21 April 2025 Every journey begins somewhere, and for me, this is it.Welcome to my blog. I’m a healthcare professional with a medical, public health, and oral health education background. Over the years, I’ve worked in both clinical and community-based roles, but what has remained consistent is my interest…