28 January, 2026
Author : Dr Vijaykumar Gawali

Topic : SAFETY REPORTING – SAE SUBMISSION WORKFLOW

1 Definition

A Serious Adverse Event (SAE) is any untoward medical occurrence that:

• results in death
• is life-threatening
• requires hospitalization or prolongation of hospitalization
• results in persistent or significant disability/incapacity
• results in congenital anomaly/birth defect
• or any other medically significant event

SAEs require 24-hour reporting to:

• Sponsor
• Ethics Committee
• CDSCO (via SUGAM portal, if applicable)
• PI oversight

India’s NDCT Rules 2019 provide strict timelines for SAE reporting.

2 CRC Responsibilities in SAE Reporting

2.1 Initial 24-Hour Notification

CRC must coordinate with PI to:

• Complete Form SAE-F (Table-5)
• Gather initial medical records
• Notify sponsor within 24 hours
• Upload required documents to SUGAM (if applicable)

CRC prepares:

• initial narrative
• causality signed by PI
• event summary

2.2 Detailed Day-14 Report

Within 14 days:

• Updated SAE-F
• CIOMS form (if sponsor provides)
• Signed ICF
• Protocol version active at time of event
• Standard of care documentation (SOC)
• Updated medical records
• Treatment cost if applicable (compensation assessment)

2.3 Ongoing Follow-Up

CRC tracks:

• Additional medical reports
• Lab updates
• Clinical progress notes
• Follow-up imaging
• PI updated causality

Filed in:

• ISF SAE section
• Safety logs

3 Documentation Requirements (Critical for CRC)

• Source notes clearly documenting onset, severity, PI assessment
• ECGs, labs, discharge summaries
• Copies of all submissions
• EC/Sponsor acknowledgements

4 Compliance Requirements

• Strict adherence to 24-hour and 14-day timelines
• PI must sign all medical causality statements
• No SAE should be kept pending for CRA review
• Maintain transparency and accuracy