This document outlines the responsibilities and timeline for reporting serious adverse events (SAEs) that occur during clinical trials. It states that the investigator must report any SAEs to the relevant authorities within 24 hours. The sponsor then has 14 days to analyze the SAE and forward the report. For an SAE of death, the investigator must send the report to various committees within 14 days. The ethics committee then has 30 days to analyze SAE reports and provide their opinion on compensation. SAEs of death are also sent to an expert committee, who has 105 days to examine the report and provide recommendations. Finally, the licensing authority has 150 days to issue a final order on compensation, which the sponsor must then pay within 30 days

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.

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.

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.

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.

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).

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%20Com
pensation%20on%20clincial%20trial%20(1).pdf
 http://www.cdsco.nic.in/writereaddata/1Draft%20Rules%20on%20co
mpensation.pdf