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Understanding Protocol Amendments: A Beginner’s Perspective By ‘Femi Fajimi | 14 May 2025 As I continue developing my skills in regulatory medical writing, I’m learning that clinical trial protocols don’t always remain fixed. In practice, they often need to be revised, and that’s where protocol amendments come in. Understanding amendments has helped me see how…
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Understanding the ICH Guidelines: E3, E6, and E8 from a Medical Writer’s Perspective By ‘Femi Fajimi | 05 May 2025 Becoming confident in regulatory medical writing involves more than understanding clinical content; it also means becoming familiar with the guidelines that shape how studies are conducted and reported. The International Council for Harmonisation (ICH) issues…
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Basic Results and Trial Disclosure Reporting: Transparency in Action By ‘Femi Fajimi | 30 April 2025 As I continue developing as a regulatory medical writer, one key area that stands out is the importance of trial transparency. Clinical research does not end when a study closes; it extends to how results are reported and shared…
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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…
