2. Principal Consultant

4. Where do we stand ?

5. Awareness Vs Documented Training Investigator sites audited

6. Awareness / Documented Training Investigator sites audited

7. % of Investigator sites Institutional Ethics Committee Vs Independent Ethics Committee

8. Ethics Committee compliance to Schedule Y requirements Investigator sites Ethics Committee

9. Compliance to EC requirements Investigator sites During Study

10. SOP & Compliance Investigator sites

11. SOP Training Investigator sites

12. Inherent Issues Lack of Past Medical Records

13. Inherent Issues Documentation Practice & Data Reliability

14. Documentation Practice File Notes Changes Insertions Cancellations Back-dating Inadvertently!!!!!!

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!!!!!!

16. Documentation Issues Source data supporting the Inclusion Criteria

17. Documentation Issues Qualifying ECG in a Cardiology study

18. Documentation Issues Report supporting the primary efficacy parameters of the study CRF had recorded the initial lesion measurement

20. Date of signatures

21. Different letters issued on same dates

23. Unique Identifier Investigator sites audited Practically impossible to cross check past visits

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?

32. US FDA Inspections -India Investigator sites INDIA

35. If we are able to overcome our documentation deficiencies we can certainly take clinical research in India to a different level!!

36. Thank You