Start Up Fees
This mandatory meeting occurs occurs before trial launch to train site investigators on protocol
What is an IM or SIV
This file tracks all the essential documents and requires dedicated archiving resources
What is the Investigator Site File or Trial Master File
This type of procedure-based site funding reimburses the site for actual tests, labs and visits performed
What is activity-based or per-patient funding
This expensive event happens when a patient signs the consent form but fails to meet clinical eligibility
What is a screen fail
This fee is paid to ensure we maintain good relationships with our fellow sites
What is a referral fee
This start-up cost involves processing of regulatory documents and submitting them to the IRB
What is an Ethics Fee
This institution regulates research studies in Canada
What is Health Canada
This non-clinical percentage is added to every study budget to cover facility infrastructure
What is overhead (or Indirect cost)
Modifications to the Study Protocol during the study triggers these costly events
What are protocol amendment fees
These costs are used when ad hoc events occur or additional assessments are required
What is Invoiceable items
This line item allows for handling investigational product, accountability and requires dedicated budget allocation
What is the Pharmacy Set up fee
This staff member spends the most time on the study
Who is the Clinical Research Coordinator
This economic factor must be added to multi-year budgets to account for rising costs
What is inflation
This cost can easily be overlooked when a CT scan for assessment of AE, is required, and the CT is usually sent to a Central Vendor.
What is the local over-read and reporting cost
Negotiating this type of fee protects the site against losses when reviewing a patient database.
What is a pre-screening Fee
This entity holds the ultimate regulatory and data integrity of the study
Who is the Sponsor
This fee is charged to manage the review of regulatory and source documents
What is Monitoring Visit Fee
This factor should be added to Coordinator costs to account for operational costs
What is Employment Benefits
These items were an unexpected new cost during 2020 that had to be rapidly negotiated
What is PPE or COVID testing
What term is used for costs that are to be paid even when the contract is not executed.
What is Non-refundable cost
This version is the most recently Health Canada approved Good Clinical Practice Guideline
What is ICH E6(R3)
This is the average increase % between intial budget from Sponsor and final
What is 35%
This is a fee that is often insufficiently offered on inital budget and is a regulatory requirement by all academic institutions
What is archiving costs
This invoiceable item should be remembered in order to support new staff and returning staff
What is a retraining/reaccrediting fee