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As a final support, we have set up a financial resource, a research revenue cycle (RRC) primer. Although experienced research professionals may not require an explanation, many seek out ideas and options for refining their current tools. We hope this primer will help provide a high-level perspective and fill in the gaps for less-experienced research professionals. We always appreciate help from store associates when we go into a home improvement store because we often have no idea where the item we need is located in the store or how to best use it. And like hardware, research spreadsheets and templates can be modified to fit the purpose of the job.

This RRC primer is organized into process sections so you can see how the financial activities are directly connected to what is happening with the clinical trial processes. We hope you find it useful as we pull the relevant information and templates together and explain their purpose and uses.

OVERVIEW

Starting with an overview of the research revenue cycle (see Form A.1), we see financial activities for contracting, the investigator’s study feasibility assessment, and sponsor payments. One way to demonstrate the financial work stream within clinical trials is to separate the activities into three phases. For our purposes, we will call these phases the pre-study, the contracting period, and the reconciliation phases. Each of the financial work stream activities is connected to what is happening with the clinical trial activities, and we’ll reference these clinical activities during the explanation of the financial phases.

FORM A.1

Research Revenue Cycle (E2E View)

Time is a factor, but activities in the phases are not always time dependent. For example, reconciliation and report activities should be ongoing once the contract and regulatory approvals are final; they should not be delayed until the end of the study. Take a look at the flow diagram titled “Research Revenue Cycle (E2E View)” (Form A.1). You will notice that while the activities on the top half of the page have a linear component, progressing from the appearance of the clinical trial agreement (CTA) to feasibility and monthly finance management, the lower half of the page shows the two perspectives, one from the investigator and the other at a department level for the research enterprise.

THE PRE-STUDY PHASE

At this point, the investigator may be conducting trials, but no new trial is imminent. Experienced research professionals know that it’s only a matter of time before a new trial is started and a new trial is prepared for the contract and regulatory approval process.

ESSENTIAL DOCUMENTS

Investigators should have financial infrastructure that supports a standardized process for the intake of new studies. Creating a standardized checklist of documents and process steps with essential ...

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