Polaris

CompanyInitial Submission Form (continued)Drugs If this study involves a drug, complete this section.This study is: Phase I Phase II Phase III Phase IV TreatmentIND # (if applicable):______________Is there a washout period associated with this study? Yes NoWill placebo be used during the washout period? Yes No Not applicableIf “yes,” will subjects be monitored during this period? Yes NoDescribe: ______________________________________________________________Devices If this study involves a device, complete this section.Class of device: Class I Class II Class III UnclassifiedThis device is: Investigational MarketedIDE # (if applicable):______________ or 510(k) clearanceThis is a significant risk non-significant risk study.FinancialDoes the Investigator, Subinvestigator, or Study Coordinator havea financial or commercial interest in the study being conducted?(If “yes,” this information must be disclosed on the consent form.)If “yes,” explain: _____________________________________________________________YesNoSponsor InformationIs the research investigator initiated? Yes No (If “yes,” skip this section.)Sponsor company:Sponsor contact name:Sponsor contact mailing address:Sponsor contact phone:Sponsor contact fax:Sponsor contact e-mail:Initial Sub.doc© 2004 by CRC Press LLC