Trial master file structure, completeness and the quality checks that keep a study inspection ready.
4 sections · 12 lessons · 6h total
Trial master file structure, completeness and the quality checks that keep a study inspection ready.
Written for people already working near this topic who need sharper practice. You work through 4 sections built around the tasks the role actually asks for, each with a short worked example and a checkpoint so you can tell whether the material has landed.
This sits in Study operations: Start-up, budgets, vendors and project delivery. When you are ready to show the capability rather than describe it, the next step is Documentation quality domain evidence.
Where it leads
Documentation quality domain evidence. Completing a course builds capability. It does not by itself create Passport evidence: demonstrated work in Wonja Labs does.
Feasibility through green light: the path most studies lose time on, and where that time actually goes.
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Costing a protocol properly, negotiating a budget and reading the clauses that matter in a CTA.
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Timelines, budgets, vendors and risk across a study, for people moving from execution to accountability.
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