Stage 9 · Toolkit 9.5
Aggregate Reporting
Manage PSUR/PBRER/DSUR planning, data contributions, QC, submission, and tracking.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Aggregate Reporting.
How it helps your team
Connect day-to-day safety operations with visible ownership, evidence, and inspection readiness.
Designed for
QPPVs, Heads of Pharmacovigilance, Drug Safety, PV Operations, Medical Safety, Quality, and affiliate teams.
Included files
Know exactly what the toolkit contains
The file names below show what is included. File contents become available only after purchase.
Word documents
- Aggregate Reporting SOP
- PSUR/PBRER Template
- DSUR Template
- Aggregate Report QC Checklist
- Data Lock Point Checklist
- Aggregate Report Decision Memo
Excel workbooks
- Aggregate Report Calendar
- Report Development Tracker
- Data Contribution Tracker
- QC Comment Tracker
- Aggregate Evidence Matrix
Related toolkits
Continue within stage 9
ICSR Case Management
Manage adverse event case intake, processing, QC, medical review, reporting, follow-up, and closure.
9.2Literature Surveillance & Review
Manage literature search, screening, medical review, reportability, and evidence of surveillance.
9.3Signal Management
Detect, validate, prioritise, assess, escalate, document, and close safety signals.