First of all, do not be afraid to renegotiate portions of the budget. In order to renegotiate the budget, it is important to have justification of why an item should be added into the budget or a price should be increased. The justification can be as simple as study activity taking twice as long as expected, requiring a budget that more accurately reflects the cost. If justification is provided, then most sponsors are amenable to renegotiating a portion of the budget. In our renegotiation experience, the sponsor/CRO has already seen similar requests from other sites. A common area for renegotiation is screen fails. If the sponsor caps screen fails, we often add language into the budget stating that after the screen fail cap is reached the site may renegotiate the budget to include additional screen failures.
