[Erica]

Hi Charles, our site is similar to yours, in most cases we receive protocols in final stage very rarely the stakeholder/site have a room to make minor changes in the Site Specific Addendum where the trial is multi-sited. Responding to the situation about mothers being excluded, I guess here is where the higher levels in health such as Ministry of Health or Department of health   or any other authority  depending on the set up in your country, should intervene and  discuss with  sponsors and if necessary make it one of the necessary requirement for that study to be conducted in your area.