A strong ICSR workflow is not just about processing cases—it is about maintaining accuracy, traceability, timely review, and regulatory control at every stage.
A controlled workflow helps ensure that safety information is consistently captured, medically assessed, quality reviewed, reported within timelines, and retained with a complete audit trail.
Key Workflow Stages
- Case receipt and book-in
- Validity assessment
- Duplicate check
- Data entry and coding
- Seriousness and causality assessment
- Quality review
- Medical review
- Client / PVOIC review, where applicable
- Regulatory reporting
- Case locking
- Archival and retrieval
Key Controls
- Clear roles and responsibilities
- Defined review stages
- MedDRA and drug coding consistency
- Follow-up management
- Reporting timeline tracking
- Complete case narrative
- Audit trail maintenance
- Submission acknowledgment tracking
Common Gaps
Unclear workflow ownership, missed review steps, inconsistent coding, incomplete narratives, delayed follow-up, weak timeline tracking, and uncontrolled case closure can affect case quality and compliance.
Practical Approach
Receive | Assess | Process | Review | Approve | Report | Lock | Archive
Each stage should be clearly defined, documented, and traceable within the safety system.
How MGS Can Support
MGS supports organizations with:
- ICSR Case Management
- Safety Database Management
- Quality Review
- Medical Review
- Regulatory Reporting Support
- Workflow Configuration Support
- PV SOP Development
- PV Quality & Compliance