SOP for Safety Data Management across E2A/E2B (ICSRs) and E2F (DSUR) Specifics

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SOP for Safety Data Management across E2A/E2B (ICSRs) and E2F (DSUR) Specifics

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Published on 21/12/2025

Standard Operating Procedure for Safety Data Management across E2A/E2B (ICSRs) and E2F (DSUR) Specifics

SOP No. CR/OPS/156/2025
Supersedes NA
Page No. X of Y
Issue Date 26/08/2025
Effective Date 01/09/2025
Review Date 01/09/2026

Purpose

The purpose of this SOP is to establish a

standardized framework for managing safety data in clinical trials in alignment with ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E2B(R3) (Electronic Transmission of Individual Case Safety Reports), and E2F (Development Safety Update Report – DSUR) requirements. This ensures accurate and timely adverse event reporting to regulatory authorities, ethics committees, and global PV databases.

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Scope

This SOP applies to sponsors, CROs, pharmacovigilance (PV) teams, investigators, QA, and regulatory affairs staff engaged in safety data collection, management, reporting, and archiving. It covers SAE/SUSAR reporting, ICSR preparation and electronic submission, and DSUR compilation and submission.

Responsibilities

  • Sponsor: Ensures compliance with ICH E2A/E2B/E2F reporting standards and oversees PV systems.
  • CRO: Supports operational aspects of safety data collection and reporting.
  • Investigator: Reports SAEs/SUSARs promptly and provides complete safety data.
  • PV Department: Prepares, validates, and submits ICSRs and DSURs.
  • QA: Audits safety data management processes for compliance with ICH guidelines.

Accountability

The Sponsor’s Pharmacovigilance Head is accountable for compliance with ICH E2A/E2B/E2F requirements and for ensuring data integrity across all safety submissions.

Procedure

1. Safety Data Collection
1.1 Investigators collect SAE/SUSAR data at sites and submit within regulatory timelines.
1.2 Data is entered into the sponsor’s safety database.
1.3 Record in Safety Data Collection Log (Annexure-1).

2. ICSR Preparation (E2A/E2B)
2.1 PV team validates and codes safety data using MedDRA.
2.2 ICSRs are prepared in compliance with ICH E2A definitions.
2.3 ICSRs are transmitted electronically in E2B(R3) format to regulatory authorities.
2.4 Record submission details in ICSR Submission Log (Annexure-2).

3. DSUR Preparation (E2F)
3.1 Prepare annual DSUR covering cumulative safety data.
3.2 Include global safety database analyses, cumulative exposure data, and benefit-risk assessment.
3.3 Submit to regulators, ethics committees, and WHO PV centers as required.
3.4 Document in DSUR Submission Log (Annexure-3).

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4. Quality Control
4.1 QA reviews safety reports for completeness and accuracy.
4.2 Discrepancies are documented and resolved.
4.3 Record in Safety QC Log (Annexure-4).

5. Archiving
5.1 Safety data, ICSRs, and DSURs must be archived in TMF and PV databases.
5.2 Archiving is documented in Safety Archiving Log (Annexure-5).

Abbreviations

  • SOP: Standard Operating Procedure
  • PV: Pharmacovigilance
  • ICH: International Council for Harmonisation
  • SAE: Serious Adverse Event
  • SUSAR: Suspected Unexpected Serious Adverse Reaction
  • ICSR: Individual Case Safety Report
  • DSUR: Development Safety Update Report
  • CRO: Contract Research Organization
  • QA: Quality Assurance
  • TMF: Trial Master File
  • MedDRA: Medical Dictionary for Regulatory Activities

Documents

  1. Safety Data Collection Log (Annexure-1)
  2. ICSR Submission Log (Annexure-2)
  3. DSUR Submission Log (Annexure-3)
  4. Safety QC Log (Annexure-4)
  5. Safety Archiving Log (Annexure-5)

References

Version: 1.0

Approval Section

Prepared By Ravi Kumar, PV Specialist
Checked By Sunita Reddy, QA Officer
Approved By Dr. Anil Sharma, Head Pharmacovigilance

Annexures

Annexure-1: Safety Data Collection Log

Date Subject ID Event Reported By Status
01/09/2025 SUB-501 Fever & Headache Investigator Collected

Annexure-2: ICSR Submission Log

Date ICSR ID Submitted To Submitted By Status
02/09/2025 ICSR-2025-01 EMA EudraVigilance PV Specialist Submitted
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Annexure-3: DSUR Submission Log

Date DSUR ID Submitted To Prepared By Status
05/09/2025 DSUR-2025-01 FDA, EMA, CDSCO PV Manager Submitted

Annexure-4: Safety QC Log

Date Document Reviewed Reviewed By Status
07/09/2025 ICSR-2025-01 QA Officer Verified

Annexure-5: Safety Archiving Log

Date Document Type Archived By Location Status
10/09/2025 ICSR-2025-01 QA TMF Archived

Revision History

Revision Date Revision No. Revision Details Reason for Revision Approved By
26/08/2025 00 Initial version New SOP creation Head Pharmacovigilance

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