You’ve received the draft clinical trial budget for your study. Is that when your negotiation begins? It shouldn’t. Negotiation for your clinical trial budget should begin with the feasibility questionnaire review and completion, continue through the pre-study visit and be reinforced through communications.
Lay the groundwork prior to site selection and it will pay off during budget negotiation.
What can be done pre-selection?
First, be meticulous when you complete your feasibility questionnaire.
There’s always a variation of this question in the FQ: “Where will the site find participants for the study?”
If you simply answer, “the clinic’s database”, you may find yourself unable to justify an advertising budget (or an increase in the budget provided). Instead, the answer to this feasibility question should encompass all potential sources of candidates for the study.
Review the provided protocol synopsis and any materials very carefully. I’ve seen many times over the years a sentence buried in a synopsis or pre-study slide that can create significant expense to the site. Use your magnifying glass to carefully read the footnotes to the protocol’s table of procedures.
Plan communications to the sponsor or CRO prior to site selection so they can be used to back up budget modifications during the negotiation process.
Keeping the budget negotiation process in mind during feasibility and site selection will benefit your site as you progress through the study.
Clinical Research 
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