Guidelines for Pharmacovigilance Follow-up Procedures
1) Purpose
The purpose of this SOP is to establish standardized procedures for conducting follow-up activities for pharmacovigilance cases to ensure comprehensive data collection and accurate case assessment.
2) Scope
This SOP applies to all pharmacovigilance personnel involved in follow-up activities, including safety specialists, case handlers, and managers.
3) Responsibilities
The Follow-up Team is responsible for initiating and managing follow-up activities for pharmacovigilance cases. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.
4) Procedure
4.1 Identification of Follow-up Needs
- Review the initial case report to identify missing or unclear information that requires follow-up.
- Determine the priority of the follow-up based on the seriousness and potential impact of the adverse event.
- Document the identified follow-up needs and the rationale for follow-up.
4.2 Initiation of Follow-up
- Contact the reporter or healthcare professional who submitted the initial case report to request additional information.
- Use standardized follow-up forms or questionnaires to ensure consistency and completeness of information.
- Document all follow-up requests and communications in the pharmacovigilance database.
4.3 Follow-up Data Collection
- Collect the requested information from the reporter or healthcare professional, ensuring clarity and accuracy.
- Record the follow-up information in the pharmacovigilance database, updating the case file accordingly.
- Verify the completeness and accuracy of the collected
4.4 Follow-up Data Assessment
- Review the follow-up information to assess its impact on the overall case evaluation.
- Update the seriousness, expectedness, and causality assessment of the case based on the new information.
- Document the follow-up assessment and any changes to the case evaluation in the pharmacovigilance database.
4.5 Continuous Monitoring and Further Follow-up
- Monitor the case for any additional information or changes in the patient’s condition that may require further follow-up.
- Initiate additional follow-up requests as needed to obtain comprehensive and current case information.
- Document all further follow-up activities and updates in the pharmacovigilance database.
4.6 Quality Control
- Conduct regular quality control checks on follow-up activities to ensure accuracy and completeness.
- Address any issues or errors identified during quality control checks promptly.
- Document all quality control activities and any corrective actions taken.
4.7 Documentation and Record Keeping
- Maintain detailed records of all follow-up activities, including follow-up requests, responses, and assessments.
- Ensure all documentation is securely stored and easily accessible for audits and inspections.
- Keep a log of all data corrections and updates made during the follow-up process.
4.8 Communication
- Communicate follow-up procedures and updates to all relevant staff members.
- Provide training on follow-up tools and techniques to ensure consistency and quality.
- Report any issues or challenges encountered during follow-up activities to the PV Manager.
5) Abbreviations, if any
PV – Pharmacovigilance
6) Documents, if any
Initial case reports, follow-up forms, follow-up communications, quality control reports.
7) Reference, if any
ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VI.
8) SOP Version
Version 1.0