Guidelines for Intake of Pharmacovigilance Cases

1) Purpose

The purpose of this SOP is to establish standardized procedures for the intake of pharmacovigilance cases to ensure timely and accurate initial data capture for adverse event reports and other safety information.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the intake of case reports, including data entry operators, safety specialists, and managers.

3) Responsibilities

The Case Intake Team is responsible for the initial handling and logging of pharmacovigilance cases. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Receipt of Case Reports

1. Receive case reports through various channels, such as email, fax, phone, or electronic reporting systems.
2. Acknowledge receipt of the case report promptly, confirming the sender’s details and the date of receipt.
3. Ensure all relevant information is included in the initial case report. If information is missing, contact the sender for clarification.

4.2 Initial Case Logging

1. Assign a unique case identifier to each new report for tracking and reference purposes.
2. Log the case details into the pharmacovigilance database, including patient information, adverse event details, and reporter information.
3. Verify the accuracy and completeness of the logged information.

4.3 Triage and Prioritization

1. Assess the case to determine its seriousness and urgency based on predefined criteria.
2. Prioritize cases that require immediate action, such as serious adverse events or events involving special populations (e.g., pregnant women, children).
3. Document the triage assessment and prioritization decision in the case file.

4.4 Preliminary Data Entry

1. Enter the initial case information into the pharmacovigilance database using standardized forms and coding systems.
2. Ensure accurate and consistent data entry to facilitate further case processing and analysis.
3. Perform a preliminary review to identify any obvious data discrepancies or missing information.

4.5 Follow-Up Information

1. Identify cases that require follow-up information to complete the initial report.
2. Send follow-up requests to the appropriate sources, documenting all communications.
3. Update the case file with any new information received and reassess the case as necessary.

4.6 Quality Control

1. Conduct regular quality control checks on case intake activities to ensure accuracy and completeness.
2. Address any issues or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.7 Documentation and Record Keeping

1. Maintain detailed records of all case intake activities, including initial case reports, follow-up logs, and quality control reports.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all data corrections and updates made during the case intake process.

4.8 Communication

1. Communicate case intake procedures and updates to all relevant staff members.
2. Provide training on case intake tools and methods to ensure consistency and accuracy.
3. Report any issues or challenges encountered during case intake to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Initial case reports, follow-up logs, quality control reports.

7) Reference, if any

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

8) SOP Version

Version 1.0