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Building clinical trial budgets from the schedule of events: white paper

Building clinical trial budgets from the schedule of events: white paper

Are you wondering how you can build a detailed clinical trial budget from the protocol, whether for a site, CRO, or sponsor?

This may appear an intimidating task. You have to read the protocol carefully, find the schedule of events, calculate how many times each activity occurs during the trial, and slowly create an itemised budget spreadsheet. There are cost items buried in footnotes that you need to look for.

The documents that you will need to review include

  • Study protocol
  • Informed Consent form
  • Clinical Trial Agreement, or contract (CRA)
  • Lab manuals
  • Charge Master or Fee Schedule
  • Any information about what costs are covered by the health system or Medicare or Medicaid
  • Sponsor budget

Upload your clinical trial protocol and create a budget with AI

Protocol to budget

Upload your clinical trial protocol in PDF form to the Clinical Trial Risk Tool and create an itemised per-patient and fixed costs budget using our charge masters, or upload your own charge master.

The Clinical Trial Risk Tool provides a solution. You can upload the protocol or synopsis and it will generate an itemised spreadsheet from the schedule of events, showing the fixed and per-subject costs in different sheets. It will even create separate sheets per site for multi-site trials.

You can find out more in our white paper.

References

  1. Pfeiffer, JoAnn and Windshciegl, Marilyn with guest author Garhan, Hailey, Managing Clinical Trial Budgets & Contracts, 2nd edition, LAD Custom Publishing, Inc. ISBN #: 9 780840 174000
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How can we create a clinical trial budget from the synopsis?

How can we create a clinical trial budget from the synopsis?

A number of documents are needed to produce a complete and accurate clinical trial budget. The necessary documents typically include: the study protocol (generally the most important document for building a budget) the informed consent form the clinical trial agreement or sponsor contract any laboratory and pharmacy manuals the charge master or schedule of fees the sponsor’s budget. However, sometimes a sponsor will send only the synopsis to a CRO when requesting a quote.