Study Planning, Scope, and Schedule Management
The core idea
Planning translates a protocol into an executable study. You must understand the study startup sequence: feasibility and site selection, regulatory and IRB/IEC submissions, contract and budget execution, site initiation, then enrollment. Know the components of a work breakdown structure (WBS) and how deliverables decompose into activities that can be sequenced and estimated.
Concepts to master
Understand dependencies (mandatory, discretionary, external) and the difference between a milestone (zero duration, e.g., first patient in) and a task. Know critical path reasoning: the longest dependent sequence determines minimum duration, and float (slack) exists only off the critical path. Recognize schedule compression techniques-crashing (adding resources, usually costs more) versus fast-tracking (overlapping activities, increases risk). Understand rolling wave planning and the value of a detailed near-term schedule with a higher-level long-term plan. Enrollment forecasts, screen-failure assumptions, and recruitment timelines are schedule drivers unique to trials.
Traps
Questions often present a schedule slip and offer "add staff" as a distractor when the real issue is an unresolved dependency or an unapproved amendment. Watch for confusing fast-tracking with crashing. Another trap: treating a milestone as a task with duration. Also beware assuming all delays are the site's fault-sponsor-held activities (drug supply, central lab setup) are common external dependencies.
Rule of thumb
Before compressing a schedule, confirm the activity is on the critical path. Compressing non-critical work consumes resources without shortening the study.
Worked example
A site initiation is delayed because the contract is unsigned, which blocks IRB approval, which blocks first patient in. These are mandatory, sequential dependencies on the critical path. Adding coordinators (crashing) will not help; resolving the contract is the only lever that moves the milestone.