SAE reporting (Serious Adverse Event) On SUGAM portal effective from 14/Mar/2021

1. SAE Reporting on SUGAM
Portal
( For Studies Registered Online and Offline)
Anupam H. Bendre
Regulatory Consultant
05/Mar/2021

2. AGENDA
01. What is SAE?
02. General SAE Reporting Policy
04. SAE Reporting (Online)
02-1. Timeframe for initial SAE reports submission
02-2. Recipients of SAEs reports
04-1. SAE Reporting (24 Hours)
04-2. SAE Reporting (14th Day due Analysis Report)
05. SAE Reporting (Offline)
02-3. Process Flow of SAEs Reporting
04-3. SAE Reporting (14th Day Report by Sponsor)
04-4. SAE Reporting (30th Day Report)
05-1. SAE Reporting (24 Hours)
05-2. SAE Reporting (14th Day due Analysis Report)
05-3. SAE Reporting (14th Day Report by Sponsor)
05-4. SAE Reporting (30th Day Report)
06. E-Vartalaap
03. Process Flow for Adding Sites and SAEs Reporting

3. 1. Death
2. Life-threatening adverse drug experience
3. Inpatient hospitalization or prolongation of existing
hospitalization (for >24 hours)
4. Persistent or significant incapacity or substantial
disruption of the ability to conduct normal life functions
5. Congenital anomaly/birth defect
6. Important Medical Event (IME) that may not result in
death, be life threatening, or require hospitalization may be
considered a serious adverse drug experience.
01. What is SAE?

4. Any adverse experience that places the subject, in the view of the
investigator, at immediate risk of death from the reaction as it
occurred, or it is suspected that the use or continued use of the
product would result in the patient’s death
Life Threatening Adverse Drug Experience
Congenital Anomaly
Exposure to a medical product prior to conception or during
pregnancy resulting in an adverse outcome in the child.

5. 02.General SAE Reporting Policy
02-1. Timeframe for initial SAE reports submission
Responsible Time
Frame
Reporting
Investigator 24 hrs Sponsor or CRO, EC and
CDSCO
Investigator
(After due analysis)
14 days Head of Institution, EC and
CDSCO
Sponsor Or CRO 14 days CDSCO, Head of Institution
and EC
Ethics Committee (Report) 30 days CDSCO

6. 02.General SAE Reporting Policy
02-2. Recipients of SAEs reports
Site Principal Investigators (PI), who confirmed that SAEs
occurred in their trial, are required to report the SAEs to
CDSCO and also to their Trial Sponsor and Ethics Committees.

7. 03 & 04. Process Flow for Adding Sites and
SAE Reporting (Online)
After obtaining CT-NOC from CDSCO and registering at CTRI,
the sponsor may initiate and monitor trial
Sponsor to follow below steps to report SAE on SUGAM Portal
1. Add Site Investigator
2. Site Investigator Mapping
3. Initiate Clinical Trial
4. SAE Reported

8. 03 & 04. Process Flow for Adding Sites and
SAE Reporting (Online)
Clink on below link:
https://youtu.be/Fb75yIOEBpA
https://youtu.be/3C6jjr3ZdyU

9. 05. SAE Reporting (Offline)
Clink on below link:
https://youtu.be/CyePlJimM0o

10. 06. E-Vartalaap
To communicate with official, Applicant can use e-vartalaap facility

11. After clicking on chat icon, a communication box has open for entering the remarks.
Applicant can enter their remarks and uploaded the supported document(if any) as shown in
below:

12. After sending the message to the official, Applicant can view their previous communication
on clicking on same chat icon as shown in figure below.

13. If Applicant can again communicate with official after clicking on the “Write to Officials”
button as shown below:

14. THANK YOU