Guidelines for Pharmacovigilance Signal Detection

1) Purpose

The purpose of this SOP is to describe the process for detecting signals from pharmacovigilance data to identify new adverse reactions or changes in the frequency or severity of known adverse reactions.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in signal detection activities, including data analysis and reporting.

3) Responsibilities

The Signal Detection Team is responsible for conducting signal detection activities. The Pharmacovigilance (PV) Manager is responsible for overseeing the process and ensuring timely review and action on detected signals.

4) Procedure

4.1 Data Collection and Preparation

1. Collect adverse event data from various sources, including clinical trials, spontaneous reports, literature, and databases.
2. Ensure the data is clean, accurate, and formatted consistently for analysis.

4.2 Signal Detection Methods

1. Apply statistical methods and algorithms to identify potential signals from the data.
2. Utilize data mining techniques such as disproportionality analysis (e.g., PRR, ROR) and Bayesian data mining.
3. Review the data manually to identify any potential signals that may not be detected by statistical methods.

4.3 Signal Evaluation

1. Evaluate the clinical relevance and significance of detected signals.
2. Review the medical literature and other relevant information to support the evaluation.
3. Determine if further investigation is required based on the initial evaluation.

4.4 Signal Management

1. Document detected signals and the evaluation process in a signal management system.
2. Discuss significant signals in a signal review meeting with relevant stakeholders, including the PV Manager and medical experts.
3. Develop action plans for signals that require further investigation or regulatory reporting.

4.5 Communication and Reporting

1. Communicate detected signals to relevant internal and external stakeholders, including regulatory authorities if necessary.
2. Prepare and submit signal detection reports as required by regulatory guidelines.
3. Maintain records of all communications and reports related to signal detection activities.

5) Abbreviations, if any

PV – Pharmacovigilance
PRR – Proportional Reporting Ratio
ROR – Reporting Odds Ratio

6) Documents, if any

Signal detection reports, evaluation records, meeting minutes, action plans.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module IX.

8) SOP Version

Version 1.0