Polaris

CompanyInitial Submission Form (continued)For the Investigator or any of the Subinvestigators in this study, have any of the following everbeen, or are any currently in the process of being, voluntarily or involuntarily, denied, revoked,suspended, reduced, limited, placed on probation, not renewed, relinquished, or have you everwithdrawn, or failed to proceed with an application, for any of the following:Research privileges at this site….……………………………………... Yes NoMedical licensure in any state……………………………………..…...Other professional registration/license……………………………...…Membership on any hospital staff..…………………………………….Clinical privileges …………………………………………...………...Professional society membership or fellowship/board certification…...Any other type of professional sanction………………………………Provide documentation for all “yes” answers.YesYesYesYesYesYesNoNoNoNoNoNoStudy Site InformationType of research facility:Private practice (nonresearch)Psychiatric institutionCommercial laboratoryResearch facilityCorporate facilityHospitalClinicSchoolUniversity/CollegeOther (explain)_____________________Describe the on-site emergency equipment available:Emergency medicationsCrash cartOther (explain)_____________________Name of nearest hospital and distance from site:Does the Principal Investigator have admitting privileges at this facility? Yes NoHas the FDA, OHRP, or any other regulatory agency everaudited this site, Principal Investigator, or Subinvestigators?If “yes,” attach the audit findings including Form 483 and the response letter.How will the Investigator, pharmacist, and other study staff be trained for the study?Initial Sub.doc© 2004 by CRC Press LLC