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Increase in o/h same sponsor same year in open label study that follows a core study.

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Any insights on this?  How would you justify an increase or would you just keep old o/h?

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New study, new budget.  You can use the original to help guide and learn from it, but site costs - salaries and clinical costs are reviewed and updated annually and are applicable with inflation based on the timeline of the study. If you are setting a budget to cover more than 3 years of work, I'd also add an inflation clause in the contract requiring a X% increase to all applicable study line items if no budget amendments have occurred within a set timeframe.

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Hi Brad and Clinical Trial Confidential Group, 

Does anyone know how to word the inflation clause in the contract?  Can you give an example? 

Thank you. 

 

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I don't know about you, but my annual inflation adjustment takes place on 13sep2022 every year.  coincidence that we're negotiating this on the 14th