There are many factors to look for while preparing schedule and budget for clinical trials.

1. Start-Up Fees:
This Start-Up Fee includes all of the Internal Committee and IRB application preparations, budget negotiations, regulatory document preparation as well as on-site visits and study protocol training. It may also include the Pharmacy Start-Up, Pharmacy Close-Out, Record Storage and overall Study Close-Out.

2. Research Test Costs:
Even though the sponsor attaches a budget spreadsheet with the contract, you may be able to submit your own spreadsheet or add inline items not included in the budget spreadsheet the sponsor submits with the contract, ask the sponsor what format they require the budget in.

3. Personnel Time Expense to Conduct Study:
Consider the amount of time that a research team member will utilize in order to complete a visit. (informed consent, Inclusion/Exclusion Criteria Review, collecting vital signs, dealing with the sponsor,prepping for visits, prepping forms, subject visit contact, processing/shipping labs, Adverse Event review, Concomitant Medication Review, completing case report forms and entering data into the study electronic data base) and that research team member’s current hourly rate based on salary including fringe.