K.L.E. Academy of Higher Education and Research, Belagavi

Standard Operating Procedures of Ethics Committee

DCGI Registration No.: ECR/211/Inst/KA/201 3/RR-2016

  1. Writing, Reviewing, Distributing and Amending SOPs
  2. Constitution of an IEC
  3. Confidentiality/Conflict of  Interest Agreement
  4. Training Personnel and Ethics Committee Members
  5. Selection and Responsibilities of Independent Consultants
  6. Management of Protocol Submissions
  7. Expedited Review / Revised
  8. Initial Review of submitted Protocol
  9. Vulnerable Population
  10. Audio Visual (AV) Recording of Informed Consent Process
  11. Review of  Resubmitted  Protocols
  12. Review of Protocol Amendments SOP
  13. Continuing Review of Study Protocols
  14. Review of Final Report
  15. Review of Serious Adverse Events (SAE) Reports
  16. Intervention in Protocol Deviation
  17. Rights and Responsibilities of Research Participants
  18. Management of Study Termination
  19. IEC Members Site Monitoring Visit
  20. Agenda Preparation, Meeting Procedures and Minutes 
  21. Maintenance of Active Study Files
  22. Archives and Retrieval of Documents
  23. Maintaining Confidentiality of IEC Documents
  24. Audit and  Inspection of the IEC