P04
IND Annual Reporting at a Glance
Kristi Wiser, Quintiles, Inc.

An Investigational New Drug (IND) Application is an initial request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Continuing authorization is accomplished by submitting an IND Annual Report for each study, whether in progress or completed, until the final Clinical Study Report has been submitted to the FDA. An important component of the IND Annual Report is a summarization of deaths, adverse events, and discontinuations due to an adverse event. Among other things, for each study the IND Annual Report requires information on subject recruitment and demographics. This poster focuses on the provision of these components from the perspective of a statistical programmer, bu t also covers the IND Annual Report in general and its place in the overall drug development process.