Polaris

CompanyInitial Submission Form (continued)General InformationHow many subjects are expected to enroll in this study?How many subjects are expected to enroll at this site?When is recruitment expected to begin?When is recruitment expected to end?What is the expected duration of the subject’s participation(number of hours, days, weeks)?Will the subjects pay for any study-related procedures or articles(i.e., visits, tests, drug, etc.)? If “yes,” describe: Yes NoResearch ProceduresList all tests and procedures which will be performed for research purposes only (i.e., that fall outsithe standard of care and may not be billable to third party payers).RecruitmentWho will perform the screening evaluation of the potential subjects to determine if they areeligible for the research study?Will advertisements, posters, television or radio announcements, websites,etc. be used to recruitment purposes? (If “yes,” copies must be provided forreview.)Which of the following will be recruited for this study? (Check all that apply.)Existing patientsReferral patientsPrivate Practice patientsOut-patientsIn-patientsPaid volunteersIlliteratesHomeless/ShelterPoor/uninsuredTerminally illEmployees of SponsorEmployees of InvestigatorYesNoPregnant womenPrisonersPediatric patientsGeriatric patientsMentally retarded/disabledStudents to be recruited in their educational settingMilitary personnel to be recruited by military personnelOther (explain) __________________________________Initial Sub.doc© 2004 by CRC Press LLC