CLINICAL TRIAL RISK TOOL CLINICAL TRIAL RISK TOOL

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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Clinical Trial Risk Tool data dictionary

Clinical Trial Risk Tool data dictionary

The Clinical Trial Risk Tool estimates top down cost and itemised site budgets using proprietary cost datasets of trial costs and procedure costs. These costs are assembled from publically available data. You can click below to view our data dictionary. Clinical Trial Risk Tool Trial cost data You can download the data dictionary used for cost estimation in the Clinical Trial Risk Tool Download data dictionary

Clinical Trial Data Lookup Google Sheets™ plugin

Clinical Trial Data Lookup Google Sheets™ plugin

Clinical Trial Data Lookup Google Sheets™ plugin Do you need to look up clinical trial data from the NCT ID? Fast Data Science has developed a Google Sheets™ add-on (plugin) which finds clinical trials data. The plugin uses the clinicaltrials.gov API. Clinical Trial Data Google Sheets™ Plugin Install plugin Install the free Google Sheets™ plugin for looking up clinical trial data Install Plugin The user will provide a number of NCT IDs in column A (or whichever one they choose) in the Google Sheet™, and the tool will look up those NCT IDs and retrieve information on those trials and populate that information into columns.

How to make a clinical trial site budget

How to make a clinical trial site budget

You may have been tasked with creating a clinical trial site budget. This is a budget itemising all the costs that will be incurred at the study site. The site budget may be needed To estimate the total cost of that site running part of the trial, as part of a bid to the CRO or sponsor To identify who needs to be reimbursed for each cost item To ascertain whether or not it is feasible to run the trial at that site To ensure that the site is reimbursed for the costs that they incur while running the trial If you are building a site budget, the most important document is the study protocol.