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Standard Operating Procedure for DSUR/PSUR Preparation and Submission

Purpose

The purpose of this SOP is to provide step-by-step procedures for preparing and submitting Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs). These reports ensure systematic evaluation of cumulative safety data, regulatory compliance, and effective risk-benefit monitoring.

Scope

This SOP applies to sponsors, pharmacovigilance teams, and CROs responsible for DSUR and PSUR preparation and submission. It covers data collection, analysis, drafting, review, approval, and submission to regulatory authorities such as FDA, EMA, CDSCO, and WHO.

Responsibilities

• Pharmacovigilance Officer: Collects and analyzes cumulative safety data for DSUR/PSUR preparation.
• Sponsor/CRO: Ensures accurate preparation, quality review, and timely submission to authorities.
• Principal Investigator (PI): Provides clinical input and site-specific safety data for inclusion in DSUR/PSUR.
• QA Officer: Reviews DSUR/PSUR for accuracy, completeness, and compliance with global standards.

Accountability

The sponsor is accountable for ensuring DSUR and PSUR preparation and submission are completed within mandated timelines and meet all global regulatory requirements.

Procedure

1. Data Collection
Collect cumulative safety data from clinical trials, spontaneous reports, and literature.
Ensure data integrity, completeness, and adherence to ALCOA+ principles.

2. Data Analysis
Perform trend analysis, case-by-case review, and cumulative evaluation of AEs/SAEs.
Identify emerging safety signals and update risk-benefit assessment.

3. Report Preparation
Prepare DSUR as per ICH E2F format.
Prepare PSUR as per ICH E2C(R2) format.
Include executive summary, cumulative safety data, signal evaluation, and conclusions.

4. Internal Review
Draft DSUR/PSUR reviewed by PV team, medical experts, and QA.
Ensure sponsor sign-off before submission.

5. Submission
Submit electronically to regulatory portals: FDA (ESG), EMA (EudraVigilance), CDSCO (SUGAM).
Retain submission receipts and acknowledgments.

6. Archiving
Maintain DSUR/PSUR reports, supporting data, and regulatory correspondence in TMF and ISF.
Archive records for at least 10 years post-submission or as per regulations.

Abbreviations

• SOP: Standard Operating Procedure
• DSUR: Development Safety Update Report
• PSUR: Periodic Safety Update Report
• PI: Principal Investigator
• PV: Pharmacovigilance
• AE: Adverse Event
• SAE: Serious Adverse Event
• CRO: Clinical Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. DSUR Preparation Checklist (Annexure-1)
2. PSUR Template (Annexure-2)
3. DSUR/PSUR Submission Log (Annexure-3)

References

• ICH E2F – Development Safety Update Report Guidelines
• ICH E2C(R2) – Periodic Benefit-Risk Evaluation Report (PBRER)
• US FDA – DSUR and PSUR Guidance
• EMA – Pharmacovigilance Guidelines
• CDSCO – Safety Reporting Requirements

Version: 1.0

Approval Section

Annexures

Annexure-1: DSUR Preparation Checklist

Annexure-2: PSUR Template

Annexure-3: DSUR/PSUR Submission Log

Revision History

For more SOPs visit: Pharma SOP