The Sponsor-Investigator and central coordinating trial team should spend time planning their trial early. Depending on the complexity of the trial, it may take months of planning before the first participant can be recruited. During this period there are many activities that can be undertaken by the trial team.
This investment will facilitate a well-written protocol with built-in processes to manage trial conduct and together with early engagement with supporting departments (eg pharmacy, medical imaging, local laboratory), will reduce delays in the ethics approval/governance authorisation process.
Key questions to consider at the planning stage