Hey guys here is small presentation for SAE reporting timelines and compensation as per New Drugs and Clinical Trials Rules 2019 for India. Suggestions are welcome.

1. SAE
Within 24
Hours of
occurrence
Investigator
Sponsor EC DCGI
If not reported within
24HRs of occurrence then
reason for delay.
SAE
Report
(Initial)
SAE reporting timelines and compensation as per New Drugs and Clinical Trials Rules 2019

2. Analyzed
report
Within 14 Days of
knowledge of occurrence
(death cases)
Investigator Sponsor
DCGI
Within 14 Days of
reporting of SAE (non-
death cases)

3. Within 30 days of receiving
SAE report from Investigator
Due analysis and
opinion on
compensation
DCGI
EC

4. DCGI
Expert Committee
chairperson (death
cases)
Reports from Sponsor, EC and Investigator
60 days from the
receipt of SAE report
Expert committee
recommendations

5. DCGI ( with
recommendation of
expert committee)
Order for
compensation
Sponsor
Within 30days of receipt
of order
Pay compensation
(if related to trial)
Within 90days of
receipt of SAE report