When considering a clinical trial budget, it is important to consider following factors like to determine full cost of study do not depend solely on protocol’ study flow chart .other costs should be considered like cost related with shipping. Always take into account the hidden costs like time and cost related to CRF completion or reporting adverse events. Remember start-up costs, e.g WIRB fee for initial review, Research Pharmacy setup fee, etc. Identify which procedures are standard of care and billable to third party payors, and which procedures are study specific and billable to the sponsor. Compare your trial cost estimate with the funding first offered by the trial sponsor. Negotiate with the sponsor to address shortfalls. In order to prepare schedule consider the length of the protocol, What is projected study startup timeframe, deadlines for items such as IRB reviews, enrollment activities . Team member availability for each tasks and about the communication details.