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The budget must total the estimated per-participant costs plus all other fees
Calculate cost per visit – and total cost per participant
STEP 2: Assess feasibility
Compare the total trial budget with projected income. Do you have enough funds to cover the cost of your trial from the beginning to the end? How feasible is your protocol?
If not, need an achievable plan to source additional funding to cover the shortfall. Note the sponsoring institution may request to see this before agreeing to sponsor the trial.
STEP 3: Finalise budget
Finalise agreement/contracts with participating sites.
Note fee negotiation is common with international sites that are taking on additional responsibilities such as reporting to international regulatory agencies, facilitating lead ethics submission for a country on behalf of other sites.