Updated Timelines for Reporting of SAE

Recent Changes SAE Reporting Timeline (Updated Oct-2016)

1. Timelines for R eporting of SAE India Updated on Oct 2016 By Naveen Kumar Upadhyay

2. 1 st Step

3. Initial Reporting by investigator The Investigator shall report all serious to the Licensing Authority , The Sponsor or his representatives , and the Ethics Committee within 24 hours of their occurrence . In case the Investigator fails to report any SAE within stipulated period, he shall furnish the reason for the delay to the satisfaction of Licensing Authority along with report of SAE.

4. 2 nd Step

5. Sponsor’s responsibility Sponsor to forward report of SAE of death after due analysis to The Chairman of the Ethics Committee , Chairman of the Expert Committee , Licensing Authority and Head of the Institution within 14 (previously 10 days) days of occurrence of the event. And report of SAE other than death after due analysis shall be forwarded by sponsor to Chairman of Ethics Committee , Head of the Institution where the trial has been conducted within 14 (previously 10 days) calendar days of occurrence of SAE .

6. Responsibilities of Investigator Any report of SAE of death occurring in CT after due analysis shall be forwarded by Investigator to Chairman of Ethics committee and Chairman of Expert Committee with a copy of report to Licensing Authority and Head of the institution where the trial has been conducted within 14 (previously 10 days) calendar days of occurrence of SAE of death. And report of SAE other than death after due analysis shall be forwarded by Investigator to Chairman of Ethics committee , Head of the institution where the trial has been conducted within 14 (previously 10 days) calendar days of occurrence of SAE.

7. 3 rd Step

8. Responsibilities of Ethics Committee In case of SAE of death occurring to CT subject Ethics committee shall forward its report after due analysis along with opinion on financial compensation, if any, to be paid by the sponsor or his representative who ever has obtained the permission from Licensing Authority to Chairman of Expert Committee with a copy of report to Licensing Authority within 30 (previously 21 days) calendar days of occurrence of SAE of death . In case of SAE other than death occurring to CT subject Ethics committee shall forward its report after due analysis along with opinion on financial compensation, if any, to be paid by the sponsor or his representative who ever has obtained the permission from Licensing Authority to The Licensing Authority within 30 (previously 21 days) calendar days of occurrence of SAE.

9. 4 th Step

10. Reporting to Expert committee In case of SAE of death occurring during Clinical trial to CT subject , the Licensing Authority shall forward the report of investigator, Sponsor or his representative who ever have obtained the permission from Licensing Authority for Conducting the CT and Ethics Committee to the Chairman of Expert Committee. The Expert Committee shall examine the report of SAE of death and give its recommendations to the Licensing Authority for the purpose of arriving at the cause of adverse event within 105 (Previously 30 days of receiving the report of the SAE) days of the occurrence of the adverse event.

11. 5 th Step

12. Order of Licensing Authority on the quantum of compensation to be paid The timeline for Licensing Authority to pass the final order to Sponsor is within 150 days of occurrence of adverse event (Previously 3 months of receiving the report of the SAE).

13. 6 th Step

14. Final compensation by Sponsor The sponsor or his representatives after getting the final order from Licensing Authority on the quantum of compensation to be paid will pay the said compensation to the subject within 30 days from the final order given by Licensing Authority and give report to Licensing Authority regarding compensation.

15. References http://cdsco.nic.in/html/D&C_Rules_Schedule_Y.pdf http://www.cdsco.nic.in/writereaddata/Notificatiohn%20on%20Compensation%20on%20clincial%20trial%20(1).pdf http://www.cdsco.nic.in/writereaddata/1Draft%20Rules%20on%20compensation.pdf