Polaris

SOP# SITE-007.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. The Investigator, Research Director, and Study Coordinator will work with theSponsor/CRO to develop a subject recruitment plan and ensure the budget reflectsthese activities.B. Using the eligibility criteria for the study, the Research Director or Study Coordinatorwill review records from the Investigator’s patient population to determine thesuitability and availability of candidates for the protocol. In addition, the Investigatorand staff will solicit study subjects through personal contacts in the community.C. The Investigator will review all advertisements and the mode of its communication,to determine that the procedure for recruiting subjects affords adequate protection.Advertisements include, but are not limited to, posters, flyers, form letters, publicservice announcements on local radio or TV stations (including community bulletinboards), newspaper ads, internet ads, and various electronic media.D. The Investigator and/or Study Coordinator will ensure that the advertisements arelimited to:1. The name and address of the clinical investigator2. The purpose of the research3. A summary of the eligibility criteria that will be used to admit subjects into thestudy4. A description of the benefits to the subject for participation in the study5. The location of the research6. The name and phone number of person to contact for further informationThey will also ensure that the advertisement makes no claims:1. That the drug or device is safe or effective for the purposes under investigation2. That the drug or device is in any way equivalent or superior to any other drug ordeviceE. When a potential subject is contacted concerning a specific study, the followinginformation will be entered on the Screening and Enrollment Log (Attachment A):1. Subject initials2. Date of birth3. Date screened4. If enrolled, subject number5. If not enrolled, the reasonSITE-007.0.doc© 2004 by CRC Press LLC