London School of Hygiene & Tropical Medicine, University of London

MSc Clinical Trials by Distance Learning

CT103 Clinical Trials in Practice

CTP02 Before the Trial Starts

Key Components of the Proposal
Diagram illustrating Stage 2 in the process of setting up a trial.

Figure 3b. Key components of the trial

A study proposal often includes a summary version of a study protocol, and may follow the same outline as the protocol. Details of what might go into a study protocol are summarised in the Session 4 of this unit, and how to write a protocol is more fully detailed in the advanced unit CT 201 (Protocol Development). In this session, therefore, we will focus only on the key components of the proposal that need to be stated early in the trial development as they have implications in the setting up of the trial.

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