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

1. Review the initial case report to identify missing or unclear information that requires follow-up.
2. Determine the priority of the follow-up based on the seriousness and potential impact of the adverse event.
3. Document the identified follow-up needs and the rationale for follow-up.

4.2 Initiation of Follow-up

1. Contact the reporter or healthcare professional who submitted the initial case report to request additional information.
2. Use standardized follow-up forms or questionnaires to ensure consistency and completeness of information.
3. Document all follow-up requests and communications in the pharmacovigilance database.

4.3 Follow-up Data Collection

1. Collect the requested information from the reporter or healthcare professional, ensuring clarity and accuracy.
2. Record the follow-up information in the pharmacovigilance database, updating the case file accordingly.
3. Verify the completeness and accuracy of the collected follow-up data.

4.4 Follow-up Data Assessment

1. Review the follow-up information to assess its impact on the overall case evaluation.
2. Update the seriousness, expectedness, and causality assessment of the case based on the new information.
3. Document the follow-up assessment and any changes to the case evaluation in the pharmacovigilance database.

4.5 Continuous Monitoring and Further Follow-up

1. Monitor the case for any additional information or changes in the patient’s condition that may require further follow-up.
2. Initiate additional follow-up requests as needed to obtain comprehensive and current case information.
3. Document all further follow-up activities and updates in the pharmacovigilance database.

4.6 Quality Control

1. Conduct regular quality control checks on follow-up 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 follow-up activities, including follow-up requests, responses, and assessments.
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 follow-up process.

4.8 Communication

1. Communicate follow-up procedures and updates to all relevant staff members.
2. Provide training on follow-up tools and techniques to ensure consistency and quality.
3. 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