Más contenido relacionado Similar a Investigator site audits and gcp compliance shehnaz v2.0 (20) Investigator site audits and gcp compliance shehnaz v2.07. % of Investigator sites Institutional Ethics Committee Vs Independent Ethics Committee 15. Documentation Issues The source document and the CRF showed the test was performed on 06-Jul-09 The film of the scan however, showed that the scan had been performed on 08-Jul-09 The subject had been source verified!!!!!! 18. Documentation Issues Report supporting the primary efficacy parameters of the study CRF had recorded the initial lesion measurement 25. Do we identify the monitoring device on the Temperature Monitoring Logs ? 27. Do we have systems, processes & documentation for storage of clinical laboratory samples? 35. If we are able to overcome our documentation deficiencies we can certainly take clinical research in India to a different level!!