Polaris

SOP# MON-009.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. Record RetentionAt the Study Initiation Visit, the Study Monitor should remind the Investigator that allstudy documents must be maintained for a period of two years following the date amarketing application is approved for the drug that is being investigated; or if theapplication is not approved for such indication, until two years after the investigationis discontinued and the sponsor notifies the FDA that the investigation isdiscontinued.B. General InstructionsEach section of the study file notebook should contain documentation or include amemo indicating that section is not applicable for that particular study, or a statementexplaining where the information can be found.Information within each section must be filed in chronological order so that the mostrecent document is at the front of the section.Each protocol requires its own separate notebook. If several protocols are beingconducted simultaneously, this may mean some documents should be copied so thatthey can be placed in both notebooks.No post-it notes or thermal fax documents should be present in the study filenotebook.No draft versions of documents should be in the notebook after a document has beenfinalized.Explanatory memos to the file are encouraged to ensure clarity.C. Physical Organization of the Site’s Study FilesAt the beginning of the study, the Monitor will provide the Investigator or StudyCoordinator with a study file binder or comparable system for organizing regulatorydocuments. To help with identification, each study file notebook should displayCompany name, IND number, protocol number, Investigator name, and site number.Certain documents are required before study drug or other supplies are shipped to thestudy site. As the study progresses, documentation of the study conduct will be addedto the files by study site personnel. At regular intervals while the study is ongoing,the Monitor will review the contents of the study binder to ensure it is current andcomplete. A thorough review of the study file notebook will be conducted at theStudy Termination Visit.MON-009.0.doc© 2004 by CRC Press LLC