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Trial planning

Clinical trial project plan

A clinical trial project plan outlines the management and operational aspects of conducting a clinical trial.

Before you start your clinical trial, there are a number of things you need to consider, such as:

  • rationale and scope
  • trial design and methodology
  • trial feasibility
  • project operations
  • regulatory oversight.

These elements all form part of your clinical trial project plan. The project plan is an overall documentation of all management and operational aspects necessary to conduct your clinical trial.

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