Guidelines for Pharmacovigilance Clinical Trials Safety Reporting

1) Purpose

The purpose of this SOP is to outline procedures for the monitoring, evaluation, and reporting of safety data during clinical trials to ensure participant safety and regulatory compliance.

2) Scope

This SOP applies to personnel involved in pharmacovigilance activities related to clinical trials, including pharmacovigilance officers, clinical research associates (CRAs), medical monitors, and clinical trial managers.

3) Responsibilities

The Pharmacovigilance Clinical Trials Safety Officer is responsible for overseeing safety reporting throughout the clinical trial lifecycle. CRAs and medical monitors ensure accurate and timely reporting of safety data.

4) Procedure

4.1 Safety Data Collection

1. Collect safety data from clinical trial sites through ongoing monitoring, site visits, and protocol-specified safety assessments.
2. Ensure completeness and accuracy of adverse event and safety report data captured from investigators and study participants.

4.2 Safety Data Management

1. Review and assess collected safety data to identify potential safety signals, adverse events, and adverse drug reactions (ADRs).
2. Classify and prioritize safety events based on severity, frequency, and relationship to study drug.

4.3 Safety Reporting Requirements

1. Prepare and submit expedited safety reports (e.g., SUSARs – Suspected Unexpected Serious Adverse Reactions) to regulatory authorities and ethics committees according to regulatory timelines.
2. Follow protocol-specific procedures for reporting safety data, including periodic safety updates and final safety reports.

4.4 Data Coding and Standardization

1. Code adverse events and medical terms using standardized dictionaries (e.g., MedDRA – Medical Dictionary for Regulatory Activities) for consistency in safety data reporting.
2. Ensure compliance with coding guidelines and conventions to facilitate data analysis and regulatory submissions.

4.5 Investigator Communication

1. Communicate safety findings and updates to investigators and study teams, providing guidance on safety reporting requirements and timelines.
2. Address queries and requests for additional information related to safety events from investigators and regulatory authorities.

4.6 Safety Data Review and Analysis

1. Conduct ongoing review and analysis of cumulative safety data to detect trends, patterns, and potential safety concerns.
2. Prepare safety data summaries and reports for study teams, regulatory submissions, and safety monitoring committees.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CRA – Clinical Research Associate, SUSAR – Suspected Unexpected Serious Adverse Reaction, ADR – Adverse Drug Reaction

6) Documents, if any

Clinical trial safety reporting plan, safety report templates, adverse event coding guidelines, regulatory submission templates.

7) Reference, if any

ICH E6(R2) – Good Clinical Practice: Integrated Addendum to ICH E6(R1), ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, ICH E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting, MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization.

8) SOP Version

Version 1.0