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Joanne Wincup

Hi Leanne,

I am adapting it to suit the needs of the CRO I work with. To do this I am keeping the same structure and adding a line next to to artifact names to state what our equivalent named document would be.
There are always going to be a zone/section/sub-section that wont be required in a particular study so adapting it to the study should be a discussion with the sponsor too. In my opinion I don’t agree with having empty sections with a file note to say it is not in use for this study – if you will never use it don’t put it in.