What needs to be done

The tasks that need to be undertaken before a trial is activated are shown in Box 7.1. An outline proposal may or may not have to be prepared and costed for the sponsor and other potential funders, but a protocol must always be written, and ethics approval obtained.

Underlying all these tasks is the need to plan and set up the trial in accordance with internationally agreed standards of practice. We therefore describe these first before considering the tasks in detail and who is responsible for fulfilling them.

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