This document provides guidance on reporting serious adverse events (SAEs) that occur during clinical trials in India. It outlines the key stakeholders involved in SAE reporting, including the investigator, sponsor/CRO, ethics committee, and Drug Controller General of India (DCGI). The timelines and process for initial and follow-up SAE reporting are defined. Requirements for the documents to be submitted in SAE reports, such as the checklist, case report form pages, and discharge summary, are also reviewed to ensure completeness and accuracy of the reports. Common errors made in SAE documentation are highlighted.

1. 1

2. OBJECTIVES
 SAE reporting timelines
 Familiarizing with the Checklist
 Documents to be submitted
 Adequacy of the documents
 Responsibilities of the stake holders
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3. Serious Adverse Event : Definition
An SAE or SAR is any untoward medical occurrence
that:
 Results in death
 Is life-threatening
 Requires inpatient hospitalization or prolongation of existing
hospitalization
 Results in persistent or significant Disability/incapacity
 Is a congenital anomaly/birth defect
 Is of medical importance
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4. SAE REPORTING –
PROCESS AND TIMELINES
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GSR 53 E dated 30 Jan 2013

5. SAE Occurrence
Initial
Report
Within 24 hours
of SAE occurrence
Investigator
DCGI
Chairman EC
Sponsor/CRO
Within 10 Calendar
Days of SAE
occurrence
Analyzed
Report
Head of
Institution
Chairman of EC
DCGI
Within 21 Calendar
Days of SAE
occurrence
Analyzed Report
& Compensation
recommendation
DCGI
Within 30 days of
Receiving report
From EC
Recommendation
on Compensation
Sponsor/CRO
Patient/Relative
Within 3 months of
Receipt of SAE
report
Order for
Compensation
Within 30 days of
Order of receipt
Final Compensation
to be paid
Chairman of Expert
Committee (DCGI)
Chairman of Expert
Committee (DCGI)
In case of Death
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6. SAE Reporting Requirement
Time lines..
 The timelines discussed is the maximum time limit to send the
information but the information should be send as early as
possible
 Clear and unequivocal information should be provided in the
SAE report.
 Keep adequate margins in the Left hand side
 The documents printed on both sides of a page, can be
submitted. However, one should take care that the information
is not obscured when the page is placed in a binder.
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7. Reporting of SAEs
PI/Designee will report the SAE to (in the SAE form)
• DCGI dci@nic.in
• Sponsor
• EC chairman
Please note to use the site letter head wherever required
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8. How to report? … completing the
Index page
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• Include a cover page
with every report
(Initial/follow ups).
• Please ensure that all
listed documents are
enclosed
• The SSE to assist the
Investigator to prepare
the SAE reports for
Submission to
CDSCO as per
Appendix XI of
Schedule-Y
• The set of documents
as per the checklist to
be arranged with
proper indexing and
page number
INDEX
Sl No Details Page No:
1 Checklist for submission of Serious Adverse Events
Report (SAE) occurring in Clinical Trials
1-2
2 Covering letter to DCGI 3-4
3 Filled Appendix XI 5-8
4 Lab reports/Discharge summary/Autopsy report 9-17
5 Additional Information 17-19
6 EC notification of SAE (initial/follow up) with
acknowledgement from the EC
20-21
7 DCGI approval letter /NOC 22-26
8 Blinded copy of signed ICF in patient’s native language 27-42
9 Blank copy of English ICF 43-63
10 Copy of eCRF pages 64-71

9. 1. Completed Checklist page 1
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All items mentioned in the checklist may not be applicable for all SAEs. The items not relevant to a
particular SAE should be marked “Not Applicable (NA)”.

10. Completed Checklist page 2
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11. 2. Covering letter to the DCGI
On the letter head of the PI/Institution
Date:
The Drug Controller General of India,
Directorate General of Health Services,
Ministry of Health & Family Welfare,
FDA Bhawan, ITO, Kotla Road,
Delhi – 110 002
Sub: Initial information of the Serious Adverse Event reported for a subject
participating in the trial mentioned
Ref: Trial ID: Protocol Name
Respected Sir,
With respect to the above mentioned study please find enclosed the documents related to
the SAE reported at <Name of the Hospital>. Please be informed that the above information
has been notified to the Sponsor, Institutional Ethic Committee and Head of the Institution
on <date>
Please find below the brief information of the event
Adverse Event
term
Date of Onset Subject No Relationship to the
Investigational
Product
Outcome
I request you to review the documents and provide the acknowledgement. In case you require
any further information please contact the undersigned
Thank you
Yours truly
Name of the PI/Designated person
Attachments:
As per the checklist
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12. ADEQUACY IN COMPLETING
THE DOCUMENTS
3. Appendix XI
 Check for the completeness and correctness
 SAE form should be filled only from the source
 Review Source, eCRF entry & Protocol before completion
Subject Details
Suspected Drug
Concomitant Drug History
Details of the Event
Outcome
Signed and Dated by the Investigator
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13. Narrating the Event
 Full description of the event (s)
 Body site
 Severity,
 criterion (or criteria ) for regarding the report as serious.
 description of the reported signs and symptoms,
 Describe a specific diagnosis for the reaction
 Event term may change during the follow up period
 Outcome: Follow up till resolution.
 All follow up reports to be notified to EC & Sponsor
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14. Causality Assessment
 SSE to provide all documents to the PI to make the
right assessment with reasoning for
Related/Unrelated/Possible/Probable .
 Source notes before/during/after the Event
 Relevant documents from other hospital (if
applicable).
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15. Analysis of SAE
The analyzed report should contain following information:
 Diagnosis/ConMed information if any.
 Whether the SAE was severe/moderate/mild
 SAE falls under which criteria of seriousness as per SAE
definition
 Whether the adverse events was serious and suspected or serious
and unexpected
 Causality assessment i.e. related to the study drug or not
 What action was taken with the study drug i.e. continued or
discontinued or interrupted for certain duration
 Whether the dose of the study drug was increased or decreased or
continued as previous dose
 Outcome of SAE i.e. resolved/not resolved/resolved with sequelae
 If SAE related to death/if Autopsy is performed -detailed Autopsy
report. 15

16. Common Errors Observed..
 Date of Birth discrepancy in the discharge summary/lab
report/Autopsy report etc.
 Units not mentioned for Height, Weight etc
 Writing the signs & Symptoms instead of mentioning the Event
name (e.g. abdominal pain instead of appendicitis)
 If the severity of the baseline illness/lab abnormality later
developed into an SAE, mismatch noticed in the start and stop
dates of AE & SAE
 Subject’s confidential information are not masked in the lab
report/discharge summary etc
 Discrepancy in the start date/stop date entry of Concomitant
medication and AE/SAE start/stop date
 Date and signature of the delegated person not present in the Lab
reports
Resolve the queries with adequate explanation, to avoid re-queries
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17. Adequacy of Documents contd..
4. Lab reports/Discharge summary
 Include lab reports showing baseline values of Investigations prior to
administration of IP & during the time of SAE (as required)
 Mask the subject identifiers (name, MRD/OP/IP no:, address etc)
 Ensure that PI/Sub I has reviewed the reports by confirming the date
and signature
5. Additional Information
 Protocol Title/Study No/Code
 CTRI Registration No
 Sponsor/CRO details
 Details about the Ethics Committee
 Site No:, Site Address
 Socio economic background of the subject viz qualification,
Occupation, monthly income
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18. Additional InformationAdditional information for Serious Adverse Event (SAE) reported for <protocol name>
1. Protocol Title:
2. Protocol study No./ID/Code:
3. Copy of clinical Trail Permission obtained from CDSCO:
Attached
4. CTRI Registration No: CTRI/2014/xx/xxxxxx
5. Sponsor (Address with contact no and Email):
Address
Telephone No Fax: Email:
6. CRO (Address with contact no and Email:
Address
Telephone No Fax: Email:
7. Initial/Follow-up (FU):
8. In case of follow-up: Date & Diary no of initial or recently submitted report information:
9. Details about the Ethics committee:
Name & Address:
Name of Chairman & Address:
Telephone/Mobile Number: Email:
10. Site No:
11. Socioeconomic Background of the subject:
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19. 6. EC Notification
Date:
To,
The Chairperson
Institutional Ethics Committee
Trial ID:
Protocol Title:
Subject: Initial/FUP information on serious adverse event reported for the <subject>on above
mentioned clinical study.
Dear sir/Madam,
The Institutional Ethics Committee has approved the referenced study in the meeting held on
<date> . We would like to inform you one SAE occurred at our site for the following subject.
Sl.No Adverse Event Term Date of Onset Subject no Relationship to
the trial drug as
per the
Investigator
Outcome
Please find the attached Appendix XI for the complete details of the event.
In case of any additional information required in this regard, please do contact undersigned.
Thanking you,
Yours faithfully,
Name & Address of the PI
Attachments: Copy of Appendix XI
Acknowledged By
Role in the EC ____________ Date:
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SSE to ensure the
initial reporting has
happened within 24
hours of
occurrence of the
event.
Confirm the date of
submission and
date of
acknowledgement
mentioned in the
Notification letter

20. Documents Required..
7. DCGI Approval Letter
8.Signed ICF
 Mask the subject identifiers except signatures (name, address,
name of the nominee address etc.)
9. English version of the ICF to be enclosed in case local
language ICF is used
10. eCRF pages
 Relevant eCRF pages where the details of the SAE are
captured
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21. SAE Reporting by Sponsor/CRO
 Upon receiving initial SAE report from Investigator,
Sponsor will perform analysis in consultation with PI
 Sponsor/ CRO will transform this information in
CIOMS Form and will submit this analyzed report
within 10 calendar days to DCGI, Chairman of EC and
Head of Institution where study is being conducted.
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22. SAE Reporting by Ethics
Committee
 The reports of SAEs of deaths should be prepared and
submitted in Red Cover.
 The reports of SAE of injury other than deaths should be
prepared and submitted in Blue Cover
 The SAE report other than death or injury is to be prepared
and submitted in White Cover. cover
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23. References
 www.cdsco.nic.in
 http://cdsco.nic.in/writereaddata/procedure%20for%20pre
screening%20and%20checklist%20_final%20on%2022-
04-2014.pdf
 System of Pre-screening for submission of reports of
SAEs for CDSCO
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24. Thank You
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