The Duke Office of Regulatory Affairs and Quality (ORAQ) will be hosting a one-hour workshop on IND forms. Forms FDA 1571, 1572 and 3674 will be reviewed, all of which are required for initial IND submissions for investigational drug studies. Recent changes in these forms will be emphasized and best practices will be reviewed. Discussion will be encouraged. This workshop is recommended for regulatory coordinators, study coordinators and anyone else who may be involved in the preparation of forms for IND submissions to the FDA.
Speaker: Daniel Tonkin, PhD, RAC