PROJECT PLANNING

Clinical study start-up three-point PERT

This three-point PERT chart estimates clinical study start-up while exposing uncertainty in regulatory review and site activation. A draft protocol begins ethics review and site selection. Selected sites are contracted, then training waits for both the ethics decision and signed site contracts. Enrollment opens only after training. Optimistic, likely and pessimistic durations give the team a way to plan around review timing and contract variability without treating them as fixed. Extend the network with budget approval, investigator meetings, data-system validation or drug supply release when those steps affect study activation.

UPDATED 2026-09-24
TYPEPert
EXAMPLEClinical study start-up three-point PERT
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CASE ANALYSIS

Scenario

A study team estimates regulatory and site-activation uncertainty.

Key decisions

  • Protocol gate: Ethics and site selection begin after the draft.
  • Site gate: Contracting follows selection.
  • Activation gate: Training needs ethics approval and contracts.

When to reuse this

Use for an early clinical study plan.

FAQ

Frequently asked questions

Why use three-point estimates?01
Review and contracting durations are uncertain.
What blocks training?02
Ethics review and site contracts.
When does enrollment open?03
After site training.
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