PV Modules

MODULE 10: QUALITY REVIEW (SECOND-LEVEL REVIEW)

Quality Review (often called QA Check or Case Quality Review) is the final internal verification step before an Individual Case Safety Report (ICSR) is submitted to regulatory authorities. The purpose is to ensure the case is accurate, consistent, compliant, complete, and audit-ready.

1. Purpose of Quality Review

QA review ensures that the case file:

· Reflects accurate medical and administrative information

· Follows all PV Standard Operating Procedures (SOPs)

· Meets global regulatory requirements (ICH, EMA, FDA)

· Is consistent across all sections of the case

· Is complete and ready for submission

It acts as the final checkpoint for quality and compliance.

2. What QA Ensures

A. Accuracy

QA verifies that all:

AE details
Drug details
Dates
Seriousness criteria
Medical coding (MedDRA, WHO-DD)
Narrative information

…are correct and match the source document.

Example:
If CIOMS lists the AE onset as 12 Jan 2025, the case must also show this date consistently in narrative, coding, and chronology.

B. Consistency

QA checks that:

No contradictions exist across the case sections
Timeline is logical
Causality aligns with narrative
Expectedness assessment matches labelling
Seriousness matches documented criteria

Example:
If the case is marked “non-serious,” the narrative should not describe “patient was admitted”, which implies seriousness.

C. Alignment with SOPs & Regulatory Guidelines

QA ensures compliance with:

ICH E2B guidelines
EU/US reporting rules
Company SOPs for case processing
Data privacy policies
MedDRA/WHO-DD coding guidelines
Good Pharmacovigilance Practices (GVP Module VI)

D. Formatting Correctness

QA checks formatting such as:

Proper template use
Date formats (e.g., DD-MMM-YYYY)
Structured narrative
Correct section completion
Use of accepted medical abbreviations
Completion of mandatory fields

Proper formatting ensures the case is readable and acceptable to health authorities (EMA, MHRA, FDA).

3. Key QA Checklist Items

A typical QA review includes:

Ø Minimum 4 criteria present

Patient
Reporter
Suspect drug
AE

Ø Seriousness criteria justified and accurate

Ø Expectedness correctly evaluated

Ø Timeline correct and logical

Ø Proper medical coding

Ø Narrative completeness & clarity

Ø Causality justified

Ø No missing mandatory fields

Ø Follow-up required or not indicated clearly

Ø Final sign-off recorded

4. Audit Trail Requirements

A complete audit trail must be maintained for:

Ø Case receipt

Ø Data entry

Ø Medical coding changes

Ø Narrative edits

Ø Seriousness updates

Ø Causality revisions

Ø QA corrections

Ø Final submission

The audit trail ensures traceability, allowing regulators or auditors to see who made which change and when.

5. Outcome of QA Review

After QA check:

• Case is approved for submission

• Case is sent back for correction (queries raised)

Only after QA approval can the case move to:

Regulatory submission
E2B XML generation
Transmission to EMA/FDA/NCA

6. Example QA Findings (Common Issues Identified)

❌ Incorrect MedDRA PT selected

→ Corrected by QA reviewer

❌ Narrative missing vital medical history

→ Case returned for medical reviewer follow-up

❌ Inconsistent dates between source and database

→ Corrected before submission

❌ Seriousness marked incorrectly

→ Updated based on ICH criteria

❌ Expectedness mismatch with SmPC

→ Corrected during QA

7. Importance of QA Review

Quality Review ensures:

Ø Regulatory compliance

Ø Zero data errors

Ø High-quality ICSRs

Ø Reduced EMA/FDA rejection rate

Ø Consistency across global case processing teams

Ø Strengthening company’s safety governance

It protects both patients and the company.