Guidelines for Processing Pharmacovigilance Cases

1) Purpose

The purpose of this SOP is to define the procedures for processing pharmacovigilance cases to ensure timely and accurate reporting of adverse events and other safety information.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the case processing activities, including case intake, assessment, and reporting.

3) Responsibilities

The Case Processing Team is responsible for handling pharmacovigilance cases. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal policies.

4) Procedure

4.1 Case Intake

1. Receive and acknowledge all incoming case reports promptly.
2. Log each case into the pharmacovigilance database with a unique identifier.
3. Verify the completeness of the initial case information and request additional information if necessary.

4.2 Case Assessment

1. Conduct a preliminary assessment to determine the seriousness and expectedness of the adverse event.
2. Perform a detailed review of the case report to identify any potential safety signals.
3. Document the assessment findings and any actions taken in the case file.

4.3 Data Entry

1. Enter all relevant case information accurately into the pharmacovigilance database.
2. Use standardized coding systems (e.g., MedDRA) for data entry to ensure consistency.
3. Verify the accuracy and completeness of the data entry before finalizing the case record.

4.4 Follow-up Procedures

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

4.5 Case Reporting

1. Determine the reporting requirements for each case based on regulatory guidelines and internal policies.
2. Prepare and submit case reports to regulatory authorities and other stakeholders within the required timelines.
3. Maintain a record of all submitted reports and any correspondence with regulatory authorities.

4.6 Quality Control

1. Conduct regular quality control checks on processed cases 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 processing activities, including case files, assessment findings, and reporting logs.
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 processing.

4.8 Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance
MedDRA – Medical Dictionary for Regulatory Activities

6) Documents, if any

Case reports, case files, follow-up logs, quality control reports, regulatory submissions.

7) Reference, if any

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

8) SOP Version

Version 1.0