The Art of Storytelling in Clinical Research, or: Adverse Event Narratives and their Pitfalls

In Clinical Study Reports (CSR), a short description (“narrative“) of all Serious Adverse Events (SAE) must be provided. In addition, all Adverse Events (AEs) leading to discontinuation, and AEs of special interest, must be included. Such narratives should provide a concise yet comprehensive overview of each case [...]

By |June 13th, 2018|Categories: Safety|Tags: , , , |

A hitchhiker’s guide to data review in an ongoing (“live”) study – part 1: data review for pharmacovigilance purposes

In a way, data review for pharmacovigilance purposes is the simplest and yet most demanding kind of data review, as time is a pressing matter in this context. The data are reviewed in different time frames according to the potential risks that arise from them [...]

By |November 8th, 2017|Categories: Data, eCRF & Technical, Safety|Tags: , , , , |
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