What it is planned to cover
- The delivery chain from clinical data to SDTM, ADaM, outputs and submission, and who owns each handoff
- Programming craft versus programming operations: what a leader manages that a programmer does not
- The operating model: roles, standards, environments, QC and review, and how they interact
- Where friction concentrates: decisions, data, access, review and sign-off
- The readiness logic behind the Navigator: role, milestone, time, deliverable, dependency, risk, evidence
- A shared vocabulary for a cross-functional team
What you can use today
- CDOR framework · The readiness logic the Handbook builds on
- Glossary · Shared terminology
- Field Guide: Study Startup
Help shape this chapter
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