Polaris

SOP# SITE-007.0CompanyEffective Date: DD/MMM/YYF. When a subject is enrolled in a study, the following information will be entered on theMaster Subject Log (Attachment B):1. Subject number2. Subject name and address3. Contact information (i.e., home and work phone numbers and e-mail address)4. Date of birth5. Social security number6. Date enrolled7. Dates completed and discontinued (may be entered later)This is an internal document for Company. It will not be shared with theSponsor/CRO.IV.References21 CFR 50.20 – General Requirements for Informed Consent21 CFR 50.25 – Elements of Informed Consent21 CFR 56.107 – IRB Membership21 CFR 56.109 – IRB Review of Research21 CFR 56.111 – Criteria for IRB Approval of Research21 CFR 56.115 – IRB Records21 CFR 312.60 – General Responsibilities of Investigators21 CFR 312.62 – Investigator Record Keeping and Record RetentionICH Guidelines for Good Clinical Practice (E6) section 3.1 – ResponsibilitiesICH Guidelines for Good Clinical Practice (E6) section 4.3 – Medical Care of TrialSubjectsICH Guidelines for Good Clinical Practice (E6) section 4.4 – Communication withIRB/IECFDA Information Sheets, Screening Tests Prior to Study Enrollment, December 1999FDA Information Sheet, Recruiting Study Subjects, December 1999FDA Information Sheet, Payment to Research Subjects, December 1999V. AttachmentsAttachment A – Master Subject LogAttachment B – Screening and Enrollment LogSITE-007.0.doc© 2004 by CRC Press LLC