Pre-study activities
Clinical Research Administration facilitates key components of the study start-up process depicted in this diagram:
Confidentiality disclosure agreement
The Industry-Sponsored Agreements team will negotiate the agreement with study sponsors on behalf of the institution and obtain the appropriate signatures.
Coverage analysis
The Clinical Research Finance team works in a way that is consistent with institutional policies on clinical trial billing compliance to create a coverage analysis and a billing grid for use in budgeting, invoicing and claims review. In addition, this tool is designed to serve as a guideline for claims processing instructions when billing sponsors and third-party payers for clinical services provided.
Study budget development
The Clinical Research Finance team has tools, templates and training are available for study teams as they works on budget development.
Contract negotiation
Under the guidance of the Office of Legal Affairs, the Industry-Sponsored Agreements team will negotiate contracts with the study sponsor and obtain the appropriate signatures.
Sponsor invoicing
The Clinical Research Finance team creates invoicing grids for data collection that will be used once the study is open to generate invoices to sponsors and follow-up until collection on industry-sponsored accounts receivable.
Synchronization
The Clinical Research Core completes an internal review of all study documents prior to institutional endorsement to ensure our informed consent documents for research subjects are consistent with the coverage analysis, budget, and what was negotiated in the contract with the study sponsor.
Account setup
Once a clinical trial agreement has been executed, an email from the Research Portal to the Office of Corporate Finance - Fund Accounting initiates the setup of the research study account. Once Sponsor Invoicing generates the final invoice for the study an email is sent from the Research Portal to inform the Office of Corporate Finance that the account can be closed.