Acquisition of Safety Data

During the course of a clinical trial it is likely that most subjects will have some form of adverse events (AEs). The longer the study and the sicker the subjects are, the more AEs there will be. Since AEs do not actually have to be related to the treatment, the sites report everything from colds, to falls, to car accidents, to murder, as well as all the typical medical conditions that might be monitored by any doctor (Prokscha, 2007). Adverse events can be grouped into various categories. Two of these are  

In both cases, the investigator generally makes an assessment of  

The management of safety data requires not only all the care that management of every other type of data collected requires (recall Section 5.9) but also some extra considerations. The first of these is the process of coding. To facilitate the summarization of AE data that are collected in the subjects own words (or the investigators version of their words), and can therefore be heterogeneous, a degree of uniformity has to be introduced. For example, the terms headache,  

Serious adverse events that are seen in clinical trials and in the general use of marketed products need to be reported directly to a safety group or safety coordinator. Safety groups tend to operate and maintain their own databases for these SAE reports, or cases, because of the detailed information related to each case that they must collect (Prokscha, 2007). Each SAE case is initially entered in this system and then updated as follow-up information becomes available. 

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