27 January, 2026
Author : Dr Vijaykumar Gawali

Topic : DOCUMENTS REQUIRED FOR SUGAM PORTAL SUBMISSION OF SAE REPORTS

1 Regulatory Background

Under NDCT Rules 2019, all SAEs occurring in clinical trials in India must be reported to CDSCO via the SUGAM portal within:

• 24 hours – initial report
• 14 days – detailed follow-up report

The CRC must coordinate with the PI to ensure correct document submission.

2 Documents Required for Initial SAE Reporting (within 24 hours)

2.1Form SAE-F (Table-5)

• Mandatory regulatory format
• Includes event details, initial treatment, PI’s causality
• Must be fully completed and signed by PI

2.2 Ethics Committee Registration Certificate

• Confirms that EC reviewing the trial is registered with CDSCO
• Required for regulatory compliance
• Must be the latest valid certificate

2.3 CDSCO NOC / Clinical Trial Approval Letter

• Required for all DCGI-approved trials
• Confirms that the trial has regulatory authorization

Additional recommended uploads (if available):

• Initial medical case summary
• Key lab values or diagnostics
• Sponsor-provided template summary (if applicable)

3 Documents Required for Day-14 SAE Follow-Up Report

3.1 Signed Informed Consent Form (ICF)

• Proof that the participant was properly consented
• Must match the EC-approved version valid at enrollment

3.2 Protocol Version Active at Time of SAE

• Confirms procedural compliance
• Helps assess if protocol-driven interventions contributed

3.3 Updated Form SAE-F (Table-5)

• Expanded clinical data
• Causality explanation
• Management summary
• Total cost of care (for compensation assessment)

3.4 Standard of Care (SOC) Records

• Hospitalization records
• Treatment summary
• Prescriptions
• Physician notes

3.5 CIOMS Form (if provided by sponsor)

• Harmonized international safety reporting format
• Often required for documentation consistency

4 CRC Step-by-Step Workflow for SUGAM Submission

4.1 For Initial 24-Hour Submission

• Receive notification of event
• Inform PI immediately
• Collect preliminary medical records
• Complete Table-5
• Obtain PI signature
• Upload:
• Table-5
• EC Registration Certificate
• CDSCO NOC
• Inform sponsor & EC

4.2 For Day-14 Follow-Up Submission

• Collect full medical records
• Update Table-5 with complete clinical data
• Attach signed ICF, protocol version, SOC records
• Prepare CIOMS (if required)
• Obtain PI signature
• Upload documents to SUGAM
• File copies in ISF & site safety binder