Financial Management

Overview

Although not a formal component, StudyTRAX can be used to track study financial management-related information.  Tracking and invoicing study and subject level costs are a good fit, whereas limited functionality is available to support budget creation, milestone tracking and integration with financial management systems. 

Topics

• FM - Considerations
• FM - Initial Setup
• FM - New Study Steps
• FM - Procedures for New Study (Detailed Case Example)

How it Works

StudyTRAX captures financial management data just like any other variable, and then links these data to the reporting features.  Typically, financial data are captured at two levels:

1. Study-Related Fees.  Study-related fees (i.e., independent of the number of subjects), for example, 
   1. Start-up fee
   2. IRB review
   3. IRB addiional reviews
   4. Pharmacy setup
2. Subject Event-Related Fees.  Event fees related to subjects, typically per visit as applicable, for example,
   1. Physical exam
   2. Adverse event assessment
   3. Study drug administration
   4. Imaging and lab processing

To accommodate these fee levels, two projects are set up.  For the Study-Related Fees project, each "subject" is a sponsor company, and each encounter has a study fee form and a report to create the invoice.  The Subject Event-Related Fees (SERF) project acts as a template containing a form with a list of all fees, fields for tracking invoice payment and associated invoice reports.  Each new study added to StudyTRAX starts as a copy of the SERF project and the fee form is added to all planned encounters (e.g., baseline, week 1, week 2), as well as a "Serious Adverse Event (SAE)" encounter.

Examples