Investigator Site Audits and GCP Compliance<br /><ul><li>Shehnaz Vakharia
Principal Consultant
Theraverity</li></li></ul><li>Disclaimer<br /><ul><li>The views and opinions expressed in the following PowerPoint slides ...
Where do we stand ?<br />
Awareness Vs Documented Training<br />Investigator sites audited<br />
Awareness / Documented Training<br />Investigator sites audited<br />
% of Investigator sites<br />Institutional Ethics Committee Vs Independent Ethics Committee<br />
Ethics Committee compliance to Schedule Y requirements<br />Investigator sites<br />Ethics Committee<br />
Compliance to EC requirements<br />Investigator sites<br />During Study<br />
SOP & Compliance<br />Investigator sites<br />
SOP Training<br />Investigator sites<br />
Inherent Issues<br />Lack of Past Medical Records<br />
Inherent Issues<br />Documentation Practice & Data Reliability<br />
Documentation Practice<br />File Notes<br />Changes<br />Insertions<br />Cancellations<br />Back-dating<br />Inadvertently...
Documentation Issues<br />The source document and the CRF showed the test was performed on 06-Jul-09 <br />The film of the...
Documentation Issues<br />Source data supporting the Inclusion Criteria<br />
Documentation Issues<br />Qualifying ECG in a Cardiology study<br />
Documentation Issues<br />Report supporting the primary efficacy parameters of the study<br />CRF had recorded the initial...
Ethics Committee-Documentation Issues<br /><ul><li>Version numbers and Version dates
Date of signatures
Different letters issued on same dates
Missing links</li></li></ul><li>Registration System<br />Investigator sites audited<br />
Unique Identifier<br />Investigator sites audited<br />Practically impossible to cross check past visits<br />
Temperature Monitoring Documentation<br /><ul><li>Do we identify the storage location on the Temperature Monitoring Logs ?
Do we identify the monitoring device on the Temperature Monitoring Logs ?
Calibration of Temperature Monitoring Device?</li></li></ul><li>Sample Storage & Documentation<br /><ul><li>Do we have sys...
Do we have systems, processes & documentation for storage of clinical laboratory samples?
Do we have documentation of shipment of clinical laboratory samples?  </li></li></ul><li>Facility<br />100<br />90<br />In...
Calibration Records<br /><ul><li>Filed in the Investigator Site File?  Yes
Comparable to the instruments?  Not always</li></li></ul><li>HOWEVER, ON A POSITIVE NOTE…..<br />
US FDA Inspections -India<br />Investigator sites<br />INDIA<br />
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Investigator site audits and gcp compliance shehnaz v2.0

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Investigator site audits and gcp compliance shehnaz v2.0

  1. 1. Investigator Site Audits and GCP Compliance<br /><ul><li>Shehnaz Vakharia
  2. 2. Principal Consultant
  3. 3. Theraverity</li></li></ul><li>Disclaimer<br /><ul><li>The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. </li></ul> <br /><ul><li>These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. </li></li></ul><li>Investigator site audits<br />Background<br />
  4. 4. Where do we stand ?<br />
  5. 5. Awareness Vs Documented Training<br />Investigator sites audited<br />
  6. 6. Awareness / Documented Training<br />Investigator sites audited<br />
  7. 7. % of Investigator sites<br />Institutional Ethics Committee Vs Independent Ethics Committee<br />
  8. 8. Ethics Committee compliance to Schedule Y requirements<br />Investigator sites<br />Ethics Committee<br />
  9. 9. Compliance to EC requirements<br />Investigator sites<br />During Study<br />
  10. 10. SOP & Compliance<br />Investigator sites<br />
  11. 11. SOP Training<br />Investigator sites<br />
  12. 12. Inherent Issues<br />Lack of Past Medical Records<br />
  13. 13. Inherent Issues<br />Documentation Practice & Data Reliability<br />
  14. 14. Documentation Practice<br />File Notes<br />Changes<br />Insertions<br />Cancellations<br />Back-dating<br />Inadvertently!!!!!!<br />
  15. 15. Documentation Issues<br />The source document and the CRF showed the test was performed on 06-Jul-09 <br />The film of the scan however, showed that the scan had been performed on 08-Jul-09<br />The subject had been source verified!!!!!!<br />
  16. 16. Documentation Issues<br />Source data supporting the Inclusion Criteria<br />
  17. 17. Documentation Issues<br />Qualifying ECG in a Cardiology study<br />
  18. 18. Documentation Issues<br />Report supporting the primary efficacy parameters of the study<br />CRF had recorded the initial lesion measurement<br />
  19. 19. Ethics Committee-Documentation Issues<br /><ul><li>Version numbers and Version dates
  20. 20. Date of signatures
  21. 21. Different letters issued on same dates
  22. 22. Missing links</li></li></ul><li>Registration System<br />Investigator sites audited<br />
  23. 23. Unique Identifier<br />Investigator sites audited<br />Practically impossible to cross check past visits<br />
  24. 24. Temperature Monitoring Documentation<br /><ul><li>Do we identify the storage location on the Temperature Monitoring Logs ?
  25. 25. Do we identify the monitoring device on the Temperature Monitoring Logs ?
  26. 26. Calibration of Temperature Monitoring Device?</li></li></ul><li>Sample Storage & Documentation<br /><ul><li>Do we have systems, processes & documentation for collection of clinical laboratory samples?
  27. 27. Do we have systems, processes & documentation for storage of clinical laboratory samples?
  28. 28. Do we have documentation of shipment of clinical laboratory samples? </li></li></ul><li>Facility<br />100<br />90<br />Investigator sites<br />80<br />70<br />60<br />50<br />Institutions<br />40<br />Clinics<br />30<br />20<br />10<br />0<br />Storage<br />Archival<br />Power Back-<br />Fire<br />up<br />Protection<br />
  29. 29. Calibration Records<br /><ul><li>Filed in the Investigator Site File? Yes
  30. 30. Comparable to the instruments? Not always</li></li></ul><li>HOWEVER, ON A POSITIVE NOTE…..<br />
  31. 31.
  32. 32. US FDA Inspections -India<br />Investigator sites<br />INDIA<br />
  33. 33.
  34. 34. US FDA Inspection Results<br /><ul><li> 09 of 17 Investigator Sites had ‘NAI’</li></ul>No Action Indicated.  No objectionable conditions or practices were found during the inspection. <br /><ul><li>07 of 17 Investigator Sites had ‘VAI’</li></ul> Voluntary Action Indicated.  Objectionable conditions were found but the problems do not justify further regulatory action. Any corrective action is left to the investigator to take voluntarily. <br /><ul><li>01 of 17 Investigator Sites had ‘VAI2’</li></ul> No response requested. <br /><ul><li>None of them resulted in ‘OAI’ </li></li></ul><li>US FDA Inspection Results<br />Investigator sites<br />Deficiency codes <br />04:Inadequate drug accountability<br />05:Failure to follow investigational plan <br />06:Inadequate and inaccurate records <br />Deficiency Code<br />
  35. 35. If we are able to overcome our documentation deficiencies we can certainly take clinical research in India to a different level!!<br />
  36. 36. Thank You<br />
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