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

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“headline”: “SOP for Safety Data Management across E2A/E2B (ICSRs) and E2F (DSUR) Specifics”,
“description”: “This SOP describes standardized procedures for managing safety data in compliance with ICH E2A, E2B, and E2F guidelines. It ensures accurate collection, validation, reporting, and archiving of ICSRs and DSURs for regulatory submissions and global pharmacovigilance obligations.”,
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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

Table of Contents

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.

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).

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

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

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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