Article
Clinical Data Readiness Playbook
June 10, 2025 · 12 min read
A practical readiness checklist to align model training, validation planning, and regulatory traceability.
Programs often move to training or evaluation with unresolved assumptions because timelines are tight and ownership is fragmented.
Readiness is not a milestone meeting. It is a repeatable quality condition that should be true before every major cycle.
Why readiness gates matter
A readiness gate protects against this by forcing explicit confirmation of core dependencies.
It also creates accountability because every gate result can be signed off and traced to responsible roles.
Without this discipline, teams usually pay the cost later in failed validation cycles and rushed documentation updates.
Readiness checklist
The checklist should stay concise and stable across cycles. The goal is repeatability, not complexity.
Teams should review the same categories every cycle so trend quality can be compared over time.
- Cohort and intended-use alignment verified.
- Protocol deviations reviewed and tagged.
- Metadata quality gate passed.
- Annotation consistency status approved.
- Subgroup evaluation definitions frozen.
- Traceability documents updated.
- Open risk register reviewed by clinical and technical leads.
- Escalation owners assigned for unresolved critical items.
After each cycle
A short retrospective should follow each cycle to capture what held, what failed, and what changed.
This creates cumulative process intelligence rather than repeating the same avoidable mistakes.
Over several cycles, teams can tune controls, reduce exception rates, and improve release predictability.
The outcome is a calmer operating model where quality and speed improve together.