vigilance Archive - CliNFo.EU - ideas, tools, knowledge & best practices in clinical research

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 Dr. Alexandre Patchev|2019-07-24T17:37:23+02:00November 8th, 2017|Categories: Data, eCRF & Technical, Safety|Tags: data review, eSAE, safety, safety reporting, vigilance|

SAE reporting in the age of digitalisation (eSAE)

The use of electronic data capture (EDC) and electronic case report forms (eCRF) is becoming the gold standard in clinical research. Today, the dream of a paperless (or at least near-paperless) study seems within reach [...]

By Dr. Alexandre Patchev|2019-07-24T17:38:23+02:00May 11th, 2017|Categories: Safety|Tags: digitalization, eCRF, EDC, eSAE, safety reporting, vigilance|

Choosing the right safety reporting workflow for your study

Safety comes first. Always. When planning a clinical project, one of the most sensitive, and coincidentally most important issues, is the establishment of a secure, feasible, functional and effective safety reporting workflow.

By Dr. Alexandre Patchev|2019-07-24T18:00:32+02:00November 17th, 2016|Categories: Safety|Tags: eSAE, notification process, safety reporting, vigilance|