Guidelines for Pharmacovigilance Clinical Trials Safety Reporting

1) Purpose

The purpose of this SOP is to outline procedures for the monitoring, evaluation, and reporting of safety data during clinical trials to ensure participant safety and regulatory compliance.

2) Scope

This SOP applies to personnel involved in pharmacovigilance activities related to clinical trials, including pharmacovigilance officers, clinical research associates (CRAs), medical monitors, and clinical trial managers.

3) Responsibilities

The Pharmacovigilance Clinical Trials Safety Officer is responsible for overseeing safety reporting throughout the clinical trial lifecycle. CRAs and medical monitors ensure accurate and timely reporting of safety data.

4) Procedure

4.1 Safety Data Collection

1. Collect safety data from clinical trial sites through ongoing monitoring, site visits, and protocol-specified safety assessments.
2. Ensure completeness and accuracy of adverse event and safety report data captured from investigators and study participants.

4.2 Safety Data Management

1. Review and assess collected safety data to identify potential safety signals, adverse events, and adverse drug reactions (ADRs).
2. Classify and prioritize safety events based on severity, frequency, and relationship to study drug.

4.3 Safety Reporting Requirements

1. Prepare and submit expedited safety reports (e.g., SUSARs – Suspected Unexpected Serious Adverse Reactions) to regulatory authorities and ethics committees according to regulatory timelines.
2. Follow protocol-specific procedures for reporting safety data, including periodic safety updates and final safety reports.

4.4 Data Coding and Standardization

1. Code adverse events and medical terms using standardized dictionaries (e.g., MedDRA – Medical Dictionary for Regulatory Activities) for consistency in safety data reporting.
2. Ensure compliance with coding guidelines and conventions to facilitate data analysis and regulatory submissions.

4.5 Investigator Communication

1. Communicate safety findings and updates to investigators and study teams, providing guidance on safety reporting requirements and timelines.
2. Address queries and requests for additional information related to safety events from investigators and regulatory authorities.

4.6 Safety Data Review and Analysis

1. Conduct ongoing review and analysis of cumulative safety data to detect trends, patterns, and potential safety concerns.
2. Prepare safety data summaries and reports for study teams, regulatory submissions, and safety monitoring committees.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, CRA – Clinical Research Associate, SUSAR – Suspected Unexpected Serious Adverse Reaction, ADR – Adverse Drug Reaction

6) Documents, if any

Clinical trial safety reporting plan, safety report templates, adverse event coding guidelines, regulatory submission templates.

7) Reference, if any

ICH E6(R2) – Good Clinical Practice: Integrated Addendum to ICH E6(R1), ICH E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, ICH E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting, MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Risk Management Activities

1) Purpose

The purpose of this SOP is to establish procedures for the identification, assessment, and management of risks associated with pharmaceutical products throughout their lifecycle.

2) Scope

This SOP applies to personnel involved in pharmacovigilance risk management, including pharmacovigilance officers, risk managers, safety scientists, and regulatory affairs professionals.

3) Responsibilities

The Pharmacovigilance Risk Manager is responsible for overseeing risk management activities. Pharmacovigilance officers and safety scientists contribute to risk assessment, mitigation, and communication.

4) Procedure

4.1 Risk Identification

1. Identify potential risks associated with pharmaceutical products based on clinical trial data, post-marketing surveillance, literature review, and regulatory feedback.
2. Classify risks according to severity, frequency of occurrence, and impact on patient safety.

4.2 Risk Assessment and Analysis

1. Conduct thorough risk assessments using quantitative and qualitative methodologies to evaluate the likelihood and consequences of identified risks.
2. Analyze risk factors, including patient demographics, product characteristics, and usage patterns, to understand risk profiles.

4.3 Risk Mitigation Strategies

1. Develop risk minimization strategies and measures to reduce identified risks, including changes to product labeling, implementation of Risk Management Plans (RMPs), and educational initiatives.
2. Collaborate with cross-functional teams (e.g., clinical development, regulatory affairs) to integrate risk mitigation strategies into product development and commercialization processes.

4.4 Risk Communication

1. Communicate identified risks and risk mitigation strategies to internal stakeholders, including pharmacovigilance teams, regulatory authorities, and senior management.
2. Prepare Risk Management Plans (RMPs) and update safety-related product information (e.g., package inserts, patient information leaflets) as necessary.

4.5 Risk Monitoring and Evaluation

1. Establish systems for ongoing monitoring and evaluation of implemented risk management strategies to assess effectiveness and adapt as needed.
2. Conduct periodic reviews of risk profiles based on new safety data, regulatory requirements, and emerging risk factors.

4.6 Continuous Improvement

1. Review and update risk management processes and procedures in response to changing regulatory requirements, scientific knowledge, and internal feedback.
2. Participate in pharmacovigilance audits and inspections to ensure compliance with SOPs and regulatory guidelines related to risk management.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, RMP – Risk Management Plan

6) Documents, if any

Risk assessment reports, Risk Management Plans (RMPs), risk communication documents, regulatory submissions related to risk management.

7) Reference, if any

ICH E2E – Pharmacovigilance Planning, ICH E2E(R2) – Pharmacovigilance Planning: ICH E2E Guideline in Context with E2C and E2D Guidelines, ICH E2C – Pharmacovigilance Safety Data Management: Definitions and Standards for Expedited Reporting, ICH E2D – Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting, ICH E2F – Pharmacovigilance Planning: Human Safety Guidelines.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Safety Signal Investigation

1) Purpose

The purpose of this SOP is to outline procedures for the investigation and evaluation of safety signals identified during pharmacovigilance activities.

2) Scope

This SOP applies to personnel involved in pharmacovigilance signal detection, including pharmacovigilance officers, safety scientists, medical reviewers, and risk management specialists.

3) Responsibilities

The Pharmacovigilance Safety Scientist is responsible for initiating and conducting safety signal investigations. Pharmacovigilance officers and medical reviewers contribute to signal evaluation and decision-making.

4) Procedure

4.1 Signal Detection and Prioritization

1. Receive and review potential safety signals identified through spontaneous reports, literature review, clinical trials, and post-marketing surveillance.
2. Prioritize signals based on seriousness, potential impact on patient safety, and regulatory reporting requirements.

4.2 Signal Investigation Planning

1. Formulate an investigation plan outlining objectives, methodologies, and timelines for signal evaluation.
2. Assign roles and responsibilities for signal investigation team members, including data collection, analysis, and decision-making.

4.3 Data Collection and Analysis

1. Gather relevant data sources, including adverse event reports, clinical trial data, epidemiological studies, and published literature.
2. Analyze quantitative and qualitative data to assess the strength of association between the drug or medical product and the identified safety signal.

4.4 Signal Evaluation and Assessment

1. Evaluate the clinical relevance and potential causality of the safety signal based on available evidence and medical judgment.
2. Conduct thorough risk-benefit assessments to determine the need for further action, including regulatory reporting, risk minimization measures, or product labeling updates.

4.5 Decision-Making and Action Planning

1. Document findings and recommendations from the safety signal investigation team.
2. Develop risk management strategies and action plans to address identified safety concerns, collaborating with regulatory affairs and product teams as necessary.

4.6 Communication and Reporting

1. Communicate investigation outcomes and recommendations to internal stakeholders, including pharmacovigilance management, regulatory authorities, and external partners.
2. Prepare and submit regulatory reports (e.g., Periodic Safety Update Reports, Risk Management Plans) as required by regulatory guidelines.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Signal investigation plan, signal evaluation reports, risk management strategy documents, regulatory submission templates.

7) Reference, if any

ICH E2E – Pharmacovigilance Planning, ICH E2D – Post-Approval Safety Data Management, ICH E2C – Pharmacovigilance Signal Detection, MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Medical Device Reporting

1) Purpose

The purpose of this SOP is to establish procedures for reporting adverse events associated with medical devices in compliance with regulatory requirements.

2) Scope

This SOP applies to personnel involved in pharmacovigilance activities related to medical devices, including pharmacovigilance officers, medical device safety specialists, and regulatory affairs professionals.

3) Responsibilities

The Pharmacovigilance Medical Device Safety Specialist is responsible for overseeing medical device adverse event reporting. Pharmacovigilance officers and safety scientists ensure accurate and timely reporting of medical device adverse events.

4) Procedure

4.1 Medical Device Adverse Event Identification

1. Receive adverse event reports associated with medical devices from healthcare professionals, consumers, clinical studies, and post-market surveillance.
2. Assess reported adverse events to determine potential association with medical device use.

4.2 Medical Device Reporting Requirements

1. Classify adverse events according to severity, impact on patient safety, and regulatory reporting criteria.
2. Follow regulatory guidelines (e.g., FDA, EU MDR) for reporting requirements, including timeframes for initial and follow-up reports.

4.3 Adverse Event Documentation and Coding

1. Document detailed adverse event information, including patient demographics, medical device details, adverse event description, and clinical outcomes.
2. Assign appropriate coding (e.g., MedDRA, ICD) to adverse events for standardized reporting and data analysis.

4.4 Reporting to Regulatory Authorities

1. Prepare and submit initial and follow-up adverse event reports to regulatory authorities (e.g., FDA, EMA) as per regulatory requirements.
2. Ensure completeness and accuracy of adverse event reports to facilitate regulatory review and decision-making.

4.5 Follow-up and Communication

1. Follow up with stakeholders (e.g., healthcare providers, consumers) to obtain additional information or clarify adverse event details as needed.
2. Communicate adverse event reporting updates and outcomes internally and externally as required by regulatory authorities.

4.6 Quality Assurance and Compliance Monitoring

1. Conduct quality assurance checks on medical device adverse event reports to verify compliance with SOPs and regulatory guidelines.
2. Monitor and evaluate compliance with regulatory reporting requirements through internal audits and assessments.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, FDA – Food and Drug Administration, EU MDR – European Union Medical Device Regulation, MedDRA – Medical Dictionary for Regulatory Activities, ICD – International Classification of Diseases

6) Documents, if any

Medical device adverse event reporting forms, adverse event coding guidelines, regulatory reporting templates.

7) Reference, if any

FDA Medical Device Reporting (MDR) Regulations, EU MDR (2017/745), MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance ICH Guidelines Compliance

1) Purpose

The purpose of this SOP is to ensure compliance with International Conference on Harmonization (ICH) guidelines related to pharmacovigilance activities, including safety reporting, risk management, and regulatory submissions.

2) Scope

This SOP applies to personnel involved in pharmacovigilance operations, including pharmacovigilance officers, safety scientists, medical reviewers, and regulatory affairs professionals.

3) Responsibilities

The Pharmacovigilance Compliance Officer is responsible for overseeing compliance with ICH guidelines. Pharmacovigilance officers and safety scientists ensure adherence to guidelines in safety reporting, risk management, and regulatory submissions.

4) Procedure

4.1 ICH Guidelines Familiarization

1. Review and familiarize with relevant ICH guidelines applicable to pharmacovigilance activities, including but not limited to ICH E2E, E2D, E2F, E6, and E9.
2. Understand the requirements and recommendations outlined in each guideline related to safety surveillance, risk management, clinical safety data management, and pharmacovigilance systems.

4.2 Implementation of ICH Guidelines

1. Integrate ICH guidelines into pharmacovigilance processes, procedures, and workflows to ensure standardized practices across safety surveillance activities.
2. Implement specific requirements for safety reporting timelines, expedited reporting, periodic safety update reports (PSURs), and signal detection and management as per ICH guidelines.

4.3 Documentation and Record Keeping

1. Maintain comprehensive documentation of ICH guideline implementation, including policy documents, standard operating procedures (SOPs), and procedural guidelines.
2. Document deviations from ICH guidelines, corrective actions taken, and any updates to procedures or practices to ensure continuous compliance.

4.4 Compliance Monitoring and Auditing

1. Conduct regular audits and compliance assessments to monitor adherence to ICH guidelines in pharmacovigilance activities.
2. Collaborate with internal audit teams, quality assurance units, and regulatory affairs to address findings from audits and implement corrective actions.

4.5 Training and Development

1. Provide training sessions and workshops on ICH guidelines to pharmacovigilance staff, including updates on guideline revisions, new requirements, and best practices.
2. Ensure ongoing competency and awareness among pharmacovigilance professionals regarding ICH guidelines through continuous education and training initiatives.

4.6 Continuous Improvement

1. Monitor updates and revisions to ICH guidelines and regulatory requirements affecting pharmacovigilance operations.
2. Implement improvements in pharmacovigilance practices, procedures, and systems to align with evolving ICH guidelines and industry standards.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICH – International Conference on Harmonization, PSUR – Periodic Safety Update Report

6) Documents, if any

ICH guideline documents, SOPs for ICH compliance, audit reports, training materials.

7) Reference, if any

ICH E2E – Pharmacovigilance Planning, ICH E2D – Post-Approval Safety Data Management, ICH E2F – Development Safety Update Report, ICH E6 – Good Clinical Practice, ICH E9 – Statistical Principles for Clinical Trials.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance MedDRA Coding

1) Purpose

The purpose of this SOP is to establish standardized procedures for the coding of adverse events and medical conditions using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in pharmacovigilance.

2) Scope

This SOP applies to personnel responsible for MedDRA coding in pharmacovigilance, including pharmacovigilance officers, safety scientists, and medical coding specialists.

3) Responsibilities

The Pharmacovigilance MedDRA Coder is responsible for accurately assigning MedDRA codes to adverse events and medical conditions reported in pharmacovigilance databases. Safety scientists and medical reviewers utilize coded data for safety assessment and regulatory reporting.

4) Procedure

4.1 Adverse Event Identification

1. Receive adverse event reports from pharmacovigilance stakeholders, clinical trials, spontaneous reports, and post-marketing surveillance.
2. Review adverse event descriptions and medical narratives to identify relevant medical terms and symptoms requiring MedDRA coding.

4.2 MedDRA Coding Process

1. Access MedDRA dictionaries and coding tools to select appropriate MedDRA terms based on the reported adverse event description.
2. Assign MedDRA preferred terms (PTs), high-level terms (HLTs), and/or system organ class (SOC) codes to accurately represent the adverse event or medical condition.

4.3 Coding Accuracy and Consistency

1. Ensure consistency and accuracy in MedDRA coding by following standardized coding conventions and guidelines.
2. Verify MedDRA codes against coding guidelines, conventions, and regulatory requirements to maintain data quality and integrity.

4.4 Quality Assurance Checks

1. Perform quality assurance checks on coded data to validate accuracy, completeness, and adherence to MedDRA coding standards.
2. Document coding discrepancies or queries and collaborate with pharmacovigilance stakeholders to resolve coding issues.

4.5 Documentation and Reporting

1. Document MedDRA coding details, including assigned codes, coding rationale, and coding guidelines used for reference.
2. Generate MedDRA coding reports for adverse event data sets, regulatory submissions, and safety signal assessments.

4.6 Continuous Training and Improvement

1. Participate in ongoing training sessions and updates on MedDRA terminology, coding updates, and best practices in pharmacovigilance coding.
2. Implement feedback and lessons learned from coding audits, regulatory inspections, and internal quality assessments to improve coding efficiency and accuracy.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, MedDRA – Medical Dictionary for Regulatory Activities, PT – Preferred Term, HLT – High-Level Term, SOC – System Organ Class

6) Documents, if any

MedDRA coding guidelines, coding rationale templates, coding query logs, coding quality assurance reports.

7) Reference, if any

MedDRA MSSO – Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization, ICH E2E – Pharmacovigilance Planning.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Database Query Management

1) Purpose

The purpose of this SOP is to establish procedures for managing queries in the pharmacovigilance database to ensure accurate and timely data retrieval for safety assessment and regulatory reporting.

2) Scope

This SOP applies to personnel responsible for querying pharmacovigilance databases, including pharmacovigilance data managers, safety scientists, and database administrators.

3) Responsibilities

The Pharmacovigilance Data Manager is responsible for overseeing database query operations. Safety scientists and pharmacovigilance officers utilize query results for safety assessment and regulatory reporting.

4) Procedure

4.1 Query Formulation and Submission

1. Receive query requests from pharmacovigilance stakeholders, including safety assessors, medical reviewers, and regulatory affairs personnel.
2. Formulate database queries based on predefined criteria, such as adverse event type, patient demographics, and product-specific parameters.

4.2 Query Execution and Data Retrieval

1. Execute formulated queries in the pharmacovigilance database management system (DBMS) to retrieve relevant safety data and adverse event reports.
2. Ensure accuracy and completeness of query results by validating data integrity and adherence to query specifications.

4.3 Data Review and Analysis

1. Review retrieved data sets to identify relevant safety signals, adverse event trends, and patient population characteristics.
2. Analyze query results for completeness of adverse event information, consistency with source documents, and compliance with regulatory reporting requirements.

4.4 Query Resolution and Follow-up

1. Resolve discrepancies or data anomalies identified during query execution through data reconciliation and verification processes.
2. Follow up with pharmacovigilance stakeholders to address query-related inquiries, provide additional data clarification, or revise query parameters as necessary.

4.5 Documentation and Reporting

1. Document query formulation, execution details, and query results in query management logs or database query history.
2. Generate query summary reports for safety assessment meetings, regulatory submissions, and internal quality assurance reviews.

4.6 Continuous Improvement

1. Conduct periodic reviews of database query processes to identify opportunities for process optimization, efficiency enhancements, and training needs.
2. Implement updates to query management procedures based on feedback, lessons learned, and evolving pharmacovigilance database technologies.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, DBMS – Database Management System

6) Documents, if any

Query management logs, query execution reports, data reconciliation summaries.

7) Reference, if any

EMA Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Pharmacovigilance Data Management.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Signal Evaluation and Prioritization

1) Purpose

The purpose of this SOP is to define procedures for the systematic evaluation, prioritization, and management of pharmacovigilance signals to ensure timely identification and assessment of potential safety concerns.

2) Scope

This SOP applies to personnel involved in pharmacovigilance signal detection, assessment, and risk management, including pharmacovigilance scientists, medical reviewers, and safety assessors.

3) Responsibilities

The Pharmacovigilance Signal Review Team is responsible for conducting signal evaluations. Medical reviewers provide clinical expertise and contribute to signal prioritization and risk assessment.

4) Procedure

4.1 Signal Detection and Identification

1. Utilize pharmacovigilance databases, literature sources, and regulatory databases to identify potential signals based on adverse event reports, epidemiological studies, and safety-related data.
2. Screen and prioritize signals for further evaluation based on predefined criteria, such as seriousness, unexpectedness, and potential public health impact.

4.2 Signal Assessment and Analysis

1. Conduct comprehensive assessment of identified signals, including review of case reports, clinical trial data, literature reviews, and previous safety assessments.
2. Evaluate clinical relevance, causal relationship, and potential mechanisms underlying identified signals.

4.3 Medical Review and Expert Consultation

1. Engage medical reviewers and therapeutic area experts to provide clinical assessment and expert opinion on signal characteristics, including severity, patient demographics, and clinical outcomes.
2. Collaborate with medical experts to prioritize signals for further investigation or risk management actions based on clinical significance and potential patient harm.

4.4 Signal Prioritization and Risk Assessment

1. Prioritize signals based on risk-benefit considerations, regulatory requirements, and potential impact on product safety profiles.
2. Perform quantitative and qualitative risk assessments to determine the need for additional data collection, regulatory reporting, or risk mitigation strategies.

4.5 Signal Management and Decision Making

1. Develop risk management plans or signal management strategies for signals requiring further investigation or regulatory action.
2. Document signal evaluation outcomes, decisions, and recommendations for risk communication, regulatory submissions, or product labeling updates.

4.6 Continuous Monitoring and Follow-up

1. Monitor evolving safety signals and update risk assessments based on new data, emerging trends, and regulatory feedback.
2. Implement proactive measures to address signal-related concerns, including additional studies, post-marketing commitments, or safety communication initiatives.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Signal detection reports, signal assessment summaries, risk management plans, expert consultation logs.

7) Reference, if any

EMA Guideline on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management, FDA Guidance for Industry – Best Practices in Drug and Biological Product Postmarketing Safety Surveillance.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Aggregate Report Approval

1) Purpose

The purpose of this SOP is to establish procedures for the review, approval, and submission of pharmacovigilance aggregate reports to regulatory authorities.

2) Scope

This SOP applies to personnel responsible for reviewing and approving pharmacovigilance aggregate reports, including pharmacovigilance managers, medical assessors, and regulatory affairs professionals.

3) Responsibilities

The Pharmacovigilance Aggregate Report Reviewer is responsible for conducting comprehensive assessments of aggregate reports. Regulatory affairs personnel coordinate submission activities and ensure compliance with regulatory timelines.

4) Procedure

4.1 Aggregate Report Compilation

1. Compile pharmacovigilance data from various sources, including adverse event reports, clinical trials, and post-marketing surveillance studies, to generate aggregate reports.
2. Ensure accuracy, completeness, and consistency of data included in aggregate reports based on predefined reporting periods and regulatory requirements.

4.2 Report Review and Assessment

1. Review aggregate reports to verify data integrity, statistical analysis methodologies, and adherence to pharmacovigilance guidelines (e.g., ICH E2C).
2. Assess the clinical relevance and significance of safety signals, adverse event trends, and risk-benefit evaluations presented in aggregate reports.

4.3 Medical Review and Sign-off

1. Engage medical assessors and therapeutic area experts to provide clinical and medical review of aggregate report findings and conclusions.
2. Obtain medical sign-off and endorsement of aggregate reports to validate clinical interpretations and ensure accuracy of safety assessments.

4.4 Quality Assurance Checks

1. Conduct quality assurance checks to verify accuracy of data coding, consistency of report formatting, and compliance with internal standards and regulatory guidelines.
2. Document findings and observations from quality assurance reviews, and address any identified discrepancies or areas for improvement.

4.5 Report Approval and Authorization

1. Approve finalized aggregate reports based on review outcomes, medical assessments, and regulatory compliance.
2. Obtain necessary approvals and authorizations from pharmacovigilance management and regulatory affairs personnel prior to report submission to regulatory authorities.

4.6 Submission and Compliance

1. Coordinate submission logistics and timelines with regulatory affairs team to ensure timely and compliant delivery of aggregate reports to regulatory authorities.
2. Monitor regulatory updates and requirements related to aggregate reporting obligations to ensure ongoing compliance and adherence to submission deadlines.

4.7 Archival and Documentation

1. Maintain records of approved aggregate reports, including version control, submission dates, and regulatory correspondence.
2. Archive aggregate report documentation in accordance with internal archiving procedures and regulatory retention requirements.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure, ICH – International Conference on Harmonisation

6) Documents, if any

Aggregate report templates, review checklist, medical sign-off forms, submission logs.

7) Reference, if any

ICH E2C(R2) – Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, FDA Guidance for Industry – Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.

8) SOP Version

Version 1.0

Guidelines for Pharmacovigilance Case Narratives Review

1) Purpose

The purpose of this SOP is to define procedures for reviewing and assessing pharmacovigilance case narratives to ensure accuracy, completeness, and compliance with regulatory requirements.

2) Scope

This SOP applies to personnel responsible for reviewing pharmacovigilance case narratives, including pharmacovigilance scientists, medical reviewers, and quality assurance professionals.

3) Responsibilities

The Pharmacovigilance Case Reviewer is responsible for conducting thorough assessments of case narratives. Medical reviewers provide clinical expertise and oversight during review processes.

4) Procedure

4.1 Case Narrative Submission

1. Receive pharmacovigilance case narratives from data entry personnel or case processors for review.
2. Verify completeness of narrative content, including patient demographics, medical history, adverse event details, and clinical outcomes.

4.2 Narrative Review Criteria

1. Evaluate case narratives for accuracy, clarity, and adherence to pharmacovigilance guidelines and reporting requirements.
2. Assess consistency between narrative content and source documents, including adverse event reports, medical records, and investigator notes.

4.3 Medical Review and Assessment

1. Engage medical reviewers to provide clinical evaluation and interpretation of case narrative information, including causality assessment and clinical significance of adverse events.
2. Collaborate with medical reviewers to resolve discrepancies, clarify medical terminology, and ensure comprehensive understanding of case details.

4.4 Quality Assurance Checks

1. Conduct quality assurance checks to verify completeness of narrative data, accuracy of data coding, and compliance with standard operating procedures.
2. Document findings, observations, and recommendations for corrective actions or further investigation as necessary.

4.5 Narrative Approval and Documentation

1. Approve reviewed case narratives based on assessment outcomes and regulatory compliance.
2. Prepare and maintain documentation of narrative review activities, including reviewer comments, revisions, and approval status.

4.6 Compliance Reporting

1. Report any identified non-compliance issues, discrepancies, or adverse findings related to case narratives to pharmacovigilance management and regulatory authorities as required.
2. Implement corrective actions and preventive measures to address compliance gaps and improve narrative review processes.

4.7 Continuous Improvement

1. Conduct periodic reviews and audits of narrative review procedures to identify opportunities for process improvement, efficiency enhancements, and training needs.
2. Implement enhancements based on lessons learned, best practices, and regulatory updates to optimize narrative review and quality assurance practices.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Case narrative review checklist, reviewer comments log, quality assurance reports.

7) Reference, if any

EMA Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products.

8) SOP Version

Version 1.0