Ann: Change of Auditor-RAP.AX, page-33

The biggest delay in the start up phase of any clinical trial or human research study is getting the approvals from local human ethics committees. Even after a trial has been "announced", every institution at every trial site will want a say in whether they think the trial protocol meets it's own local ethical standards. This can happen in a matter of weeks or can sometimes drag on for months. Drug or device manufacturers often use "private" ethics approval providers to circumvent the snails-pace, inflexible hospital and university ethics committees. However, other trial preparation activities such as training can occur in parallel, while awaiting ethics approvals.