Questionnaire survey to clinical trial sponsors on the management organization of information on adverse events

In order to examine the efficient management method of the vast amount of information on adverse events, a questionnaire survey on the evaluation organization of adverse events in a clinical trial and the implementation of information technology for information management was given to 50 clinical trial sponsors. Of the sponsors, 64% has a evaluation criteria for the causal relationship of an investigational drug and adverse events, but the 84% is "internal original standard". With 56% of sponsors, a doctor permanently resides to perform causal relationship evaluation, and 44% of sponsors rely on "outsourcing". All sponsors with no permanent residence doctor and no evaluation criteria are Japanese companies. A delay in maintenance in information management organization, including the holding frequency of the evaluation committee, was observed in Japanese sponsor. Among sponsors, 88% replied that it would be useful to create a database of adverse events, presuming that sponsors can correspond with front electric formal data. However, the sponsors do not wish to meet the request from each individual institution, rather they want to offer by standard format; both the sponsor and the institution need to agree on standard data items.