#5083
Caroline
Member

First of all, the trick is to send a draft (not final) protocol to a trial site for review and feed-back.

I would ask the site to review it first based on their knowledge and experience from other (similar) trials. If there is anything new and not explored in previous trials, I would ask the site to consult with community stakeholders to 1) inform the community about the upcoming study and planned design and 2) ask their FB and comments/concerns/questions.

After the site has consolidated this information from all different angles, I would ask to return to the sponsor so the protocol can be finalized benefiting from all stakeholder FB.

Obviously, if the protocol had been finalized and comments/FB still needs to be addressed, an amendment is due. We have experienced this before – with long turnaround times as the consequence for review and approvals.