Polaris

SOP# MON-008.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. On-Site Review of CRFsTo ensure that the data captured in the CRFs are accurate and complete, the Monitorwill verify that all data captured in the CRF are supported by source documentationand will check the CRF to determine the following:1. Are all pages present and in the correct order?2. Do all blanks for data have complete entries?3. Is the subject identifier on each page?4. Are the data legible?5. Are the dates present and is the sequence of dates logical?6. Are the data logical and consistent?7. Are errors properly corrected?a. Cross out with single lineb. Initial and date the errorc. Record the new data correctlyd. “White-out” not usede. Overscribes not used8. Are times recorded using a 24-hour clock system?9. Does the subject fit entry criteria for the study?10. Are required tests being recorded?11. If a procedure has not been performed, has the Investigator explained this on theCRF?12. Is the schedule of patient visits correct?13. Are procedures and tests accomplished on schedule?14. Are the CRFs complete and consistent with the source documents?15. Are the appropriate units of measure being used for weight, height, lab values, etc.?16. Are all calculations and scoring correct?17. Is the dose of drug given to the subject correct?18. Are the blinding procedures intact?19. Has the investigator commented on clinically abnormal laboratory values?20. Has the CRF been signed and dated by the Investigator?21. Is there the possibility that some data may be missed due to comments on theCRF such as “See page 40” or “See reverse”?22. Is there acceptable documentation in the CRF fora. Missing medications?MON-008.0.doc© 2004 by CRC Press LLC