Stage 6 · Toolkit 6.1
Phase I / First-in-Human Trial Management
Manage FIH operations, dose escalation, sentinel dosing, stopping rules, safety review, and cohort decisions.
What it helps control
Operational support
Helps teams establish the procedures, working records, trackers, and evidence needed for Phase I / First-in-Human Trial Management.
How it helps your team
Apply the right controls to the phase-specific decisions that matter most.
Designed for
Clinical Development, Clinical Operations, pharmacology, bioanalysis, statistics, safety review, and programme 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
- FIH Trial Management SOP
- Dose Escalation Plan
- Sentinel Dosing Plan
- Stopping Rules Template
- Safety Review Meeting Template
- Dose Escalation Decision Memo
Excel workbooks
- Cohort Escalation Tracker
- Dose Decision Log
- Sentinel Dosing Tracker
- Safety Review Tracker
- Emerging Safety Evidence Matrix
Related toolkits
Continue within stage 6
Phase I PK/PD & Bioanalysis Operations
Manage PK/PD sampling, bioanalysis handling, review, shipment, and evidence readiness.
6.3Phase II Proof-of-Concept & Dose-Finding
Govern dose-finding, interim analysis, efficacy endpoints, safety monitoring, and PoC decisions.
6.4Phase III Pivotal Trial Readiness
Prepare for pivotal trial scale-up, country/site readiness, risks, and operational governance.