GCP

  • From Numbers to Narrative: Learning to Understand Clinical Data as a Medical Writer  By ‘Femi Fajimi | 22 May 2025  One of the most valuable skills I’m developing as a regulatory medical writer is the ability to interpret clinical data clearly and accurately. I’m learning that writing about trial outcomes isn’t just about listing results

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  • Writing the Participant Information Sheet: A Practical Introduction By ‘Femi Fajimi | 15 May 2025 The Participant Information Sheet (PIS) is one of the most important documents a medical writer may help prepare during the early phases of a clinical trial. In plain and respectful language, it explains what the study is about, what participation

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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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  • 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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  • Understanding Informed Consent Forms (ICFs)  By ‘Femi Fajimi | 24 April 2025  Informed Consent Forms (ICFs) are at the heart of ethical clinical research. They represent the intersection between science, ethics, and patient communication. As I learn and grow in regulatory medical writing, I appreciate the depth and responsibility of developing these documents.  Although I’m

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