Stage 5 · Toolkit 5.11
Clinical Safety / SAE / SUSAR Management
Control SAE capture, reporting, SUSAR assessment, escalation, reconciliation, and safety decisions.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Clinical Safety / SAE / SUSAR Management.
How it helps your team
Connect trial execution, evidence, and decisions across sponsor, CRO, and site responsibilities.
Designed for
Clinical Operations, Clinical Development, Data Management, Biostatistics, Safety, Quality, and vendor oversight 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
- Clinical Safety Management SOP
- SAE Reporting SOP
- SUSAR Assessment Guide
- SAE Form Template
- Safety Escalation Pathway
- Safety Review Committee Charter
- Clinical Safety Decision Memo
Excel workbooks
- SAE Tracker
- SUSAR Tracker
- Safety Query Tracker
- Safety Reconciliation Tracker
- Safety Review Decision Log
- Safety Evidence Matrix
Related toolkits
Continue within stage 5
Clinical Development Plan & Study Governance
Govern clinical development plans, studies, decisions, risks, and cross-functional actions.
5.2Protocol Development & Amendment Management
Develop, review, approve, amend, and control clinical protocols.
5.3Study Startup & Site Activation
Manage startup, essential documents, investigator packages, site activation, and green-light approval.