Polaris

SOP# MON-009.0CompanyEffective Date: DD/MMM/YY17. Operations ManualsTo provide evidence that Company Monitors have fulfilled their obligation totrain the study staff, copies of all training reference materials should be includedin the study file notebook. This includes the Study Procedures or OperationsManual (if there is one), and/or guidelines for completion of CRFs, handlingadverse events, handling subject deaths, handling premature subject or studydiscontinuation, and handling, storing, and/or shipping biological samples (ifappropriate).18. Laboratory Certifications and Normal Rangesa. A clinical laboratory should be certified or licensed by at least one of threeauthorizing bodies: a state regulatory agency, the Communicable DiseaseCenter, and/or the College of American Pathologists. (Certifications for studysites outside the United States will differ.)b. Due to the raised seal, photocopies of laboratory certificates often make thedate of certification illegible. When this happens, the Monitor should writethe date of the certification on the copy.c. If certification expires during the study, an updated certification or letter ofinspection should be obtained.d. As the study progresses, the Monitor should ensure that the certificationscover the entire time interval of the study and are renewed or updated asnecessary.e. If the lab is certified on a test-by-test basis, the Monitor should ensure that thelaboratory is certified for all of the tests required by the study protocol.f. If more than one laboratory will be used, normal ranges for each test fromeach participating laboratory must be obtained.g. As the study progresses, the Monitor should ensure that the normal ranges arevalid for the entire time interval of the study and are renewed or updated asnecessary.h. If biological samples are sent to a lab that was not listed on the FDA Form1572, the Form must be updated and normal ranges for the second lab must beobtained.i. A copy of the Laboratory Director’s CV may be included in the file, but is notrequired.19. Screening and Enrollment Log (if applicable)During the Periodic Site Visits, the Monitor will ensure that the informationincluded in the Screening and Enrollment Log remains current (Attachment B).20. Study Responsibilities Forma. At the Study Initiation Visit, the Monitor must ensure that the StudyResponsibilities Form is completed to show who may perform specific studyrelatedtasks (Attachment C).b. The Study Responsibilities Form must be signed and dated by the Investigatorto reflect that he has authorized the delegation of the tasks to the peopleindicted.MON-009.0.doc© 2004 by CRC Press LLC