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Published on 21/12/2025

SAE and DSUR Reporting SOP

Department	Clinical Research
SOP No.	CS/HC-SAF/167/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to establish clear, regulatory-compliant processes for the identification, assessment, documentation, and reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and Development Safety Update Reports (DSURs) to Health Canada. It ensures timely communication, protects subject safety, maintains sponsor obligations under Division 5 of the Food and Drug Regulations, and aligns with ICH-GCP and ICH E2A/E2F guidelines.

Scope

This SOP applies to all interventional clinical trials sponsored or managed by the organization that involve investigational products submitted to Health Canada under a Clinical Trial Application (CTA). It applies to sponsor pharmacovigilance (PV), clinical research, regulatory affairs, investigators, and site staff responsible for adverse event capture, documentation, and reporting.

Responsibilities

• Principal Investigator (PI): Ensures all SAEs are documented and reported to the sponsor within 24 hours of awareness, provides causality assessment, and supports follow-up requests.
• Clinical Research Coordinator (CRC): Assists in SAE data collection, verifies source records, and maintains SAE site files.
• Pharmacovigilance (PV) Team: Performs medical review, causality assessment, prepares case narratives, and submits expedited reports to Health Canada.
• Regulatory Affairs (RA): Coordinates DSUR preparation, ensures timely submission, and files acknowledgments in the TMF.
• Quality Assurance (QA): Audits SAE/SUSAR/DSUR processes and verifies compliance with SOP and regulations.

Accountability

The Sponsor’s Qualified Safety Officer is accountable for ensuring all expedited reports and DSURs are submitted within Health Canada timelines. The Head of Clinical Research is accountable for oversight of compliance across all active trials.

Procedure

1. SAE Reporting Workflow

1. All SAEs must be recorded on the SAE Report Form within 24 hours of investigator awareness.
2. The PI must assess severity, causality, and expectedness based on the Investigator’s Brochure or Reference Safety Information (RSI).
3. Forward SAE documentation to sponsor PV team and REB as required.
4. File source documentation and completed SAE forms in Investigator Site File (ISF).

2. SUSAR Expedited Reporting

1. Fatal or life-threatening SUSARs: Report to Health Canada within 7 calendar days, followed by a complete report within 8 additional days.
2. All other SUSARs: Report within 15 calendar days of sponsor awareness.
3. Submissions must use ICH E2B format through Health Canada electronic gateway with certified translation if required.
4. Maintain SUSAR Submission Log with case ID, subject ID, event, submission date, and acknowledgment.

3. DSUR Submission

1. Prepare annual DSUR covering cumulative safety data, case listings, signal analyses, and benefit-risk evaluations.
2. Submit DSUR in CTD/eCTD format within 60 days of the data lock point.
3. Provide copies to REBs as required by institutional policies.
4. File submission receipts, acknowledgments, and DSUR archival copies in the TMF.

4. Documentation and Record-Keeping

1. Maintain SAE Case Files, SUSAR Submission Logs, and DSUR Submission Logs in TMF.
2. Archive safety documents for minimum of 25 years or until product registration is completed, whichever is longer.
3. Ensure audit trails are complete and ALCOA+ principles are met.

5. Communication with Health Canada

1. All RFIs from Health Canada must be acknowledged within 2 working days.
2. Assign responsibility to PV/RA staff for drafting responses, reviewed by QA prior to submission.
3. Document all communications in the Regulatory Communication Log.

Abbreviations

• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• DSUR: Development Safety Update Report
• REB: Research Ethics Board
• PV: Pharmacovigilance
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• RSI: Reference Safety Information

Documents

1. SAE Reporting Form (Annexure-1)
2. SUSAR Submission Log (Annexure-2)
3. DSUR Submission Log (Annexure-3)

References

• Health Canada — Clinical Trial Guidance
• Food and Drug Regulations, Part C, Division 5
• ICH E2A: Clinical Safety Data Management
• ICH E2F: Development Safety Update Report

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: SAE Reporting Form

Subject ID	Event	Onset Date	Outcome	Investigator Assessment	Date Reported
SUB-101	Severe Allergic Reaction	15/08/2025	Recovered	Related	16/08/2025

Annexure-2: SUSAR Submission Log

Case ID	Subject ID	Event	Report Type	Date Submitted	Acknowledgment
SAE-2201	SUB-102	Anaphylaxis	7-day Expedited	17/08/2025	Received

Annexure-3: DSUR Submission Log

Period	Data Lock Point	Submission Date	Acknowledgment	Submitted By
01/08/2024 – 31/07/2025	31/07/2025	25/08/2025	Yes	Sunita Reddy

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for SAE, SUSAR, and DSUR reporting.	New SOP developed for compliance with Division 5.	Head of Clinical Research

For more SOPs visit: Pharma SOP.