Guidelines for Entering Pharmacovigilance Data

1) Purpose

The purpose of this SOP is to establish the procedures for accurately and efficiently entering pharmacovigilance data into the database to ensure data integrity and facilitate timely safety monitoring and reporting.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in data entry activities, including data entry operators, safety specialists, and managers.

3) Responsibilities

The Data Entry Team is responsible for entering pharmacovigilance data into the designated database. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal policies.

4) Procedure

4.1 Data Entry Preparation

1. Ensure that all source documents are complete and available before data entry begins.
2. Review the source documents to understand the information that needs to be entered.

4.2 Data Entry Process

1. Log into the pharmacovigilance database using secure credentials.
2. Select the appropriate data entry form or module based on the type of data being entered.
3. Enter data accurately and completely into the designated fields.
4. Use standardized coding systems (e.g., MedDRA) where applicable.
5. Save the data entry at regular intervals to prevent data loss.

4.3 Data Verification

1. Perform initial verification of entered data by cross-checking with the source documents.
2. Identify and correct any discrepancies or errors found during verification.
3. Document any changes made during the verification process.

4.4 Quality Control Checks

1. Conduct regular quality control checks on data entries to ensure accuracy and completeness.
2. Randomly select a sample of data entries for detailed review by a second team member.
3. Address any issues or errors identified during quality control checks.

4.5 Data Security and Confidentiality

1. Ensure all data is entered in a secure environment to prevent unauthorized access.
2. Maintain the confidentiality of all entered data in accordance with privacy regulations.
3. Implement data encryption and access control measures to protect data integrity.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all data entry activities, including source documents and verification 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 verification and quality control processes.

4.7 Communication

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

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Data entry forms, source documents, verification 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