We stress the importance of quality reporting, which is done in the field spontaneously by health care professionals. We also encourage them to use the CIOMS V form, which is an internationally accepted standard for reporting. We believe the use of that form, by the very nature of the structure of that template, is going to help them provide the type of information the companies will require in order to make an assessment of the risk of the association between the noted adverse event vis-à-vis the drug.
The fact that an adverse event is reported per se is not as important as all the information that is required to assess the relationship of the causality between the drug and the adverse event.