SAE Reporting Project Plan Now Available
April 6, 2009
CTTI is pleased to make available the plan for the following project:Improving the System of Reporting and Interpreting Unexpected Serious Adverse Events (SAEs) to Investigators conducting research under an Investigational New Drug Application (IND. The project will generate empirical evidence and consider potential modifications of the current reporting system to more efficiently and effectively inform investigators of these events, thus optimizing protection of study participants.