[Erica]

Hi this is a challenging situation to our site, we also receive most of the protocols in final stage, although ocassionally we have an optoni of having a site specific addendum if there some areas, where the site can not comply or study on that particular area (for example, recruiting transgenders as is a rare or even unknown to our societies). At least the site is able to modify few areas, otherwise the CAB are most of the time engaged in review of the Informed consent and other recruitment materials.