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Subject Fees-

Invoicing and Internal Reporting Needs (Per Visit and Across Visits)

While none of the responses to the questions below diminish the feasibility of utilizing StudyTRAX as a financial tracking component, it will better gauge the custom development needs.

  1. Will study fees be tracked based on the patients collection schedule only?  Will there be a chance for unscheduled event fees?  ( e.g. Adverse Events)
  2. Will invoicing be needed at the individual visit (and/or) as a summary across visits?
  3. Will invoicing need to be rolled into a select number of visits?  (e.g. visit 2 3 and 4 only, for a study that includes a total of 8 visits)
  4. Are there a large number of study events universal to each new study initiated?  If not, how much variety in study related events are possible.
  5. Is it common for study event fees to vary across studies?
  6. Is it common for study event fees to vary between intervals?

Financial Event Tracking Form (Per Visit and Per Patient)

The following questions will help determine the customization necessary for study-event fees and pertinent data collection.

  1. Are there any "one-time" per-study fees applicable from one patient to the next?
  2. Will there be a pre-determined stipend for patients involved in the study, or will patient stipends vary at each individual visit?
  3. During the collection process, will any one study event fee need custom modification at the time of the visit?
  4. During the collection process, will study staff hourly rates and fees be collected.  Will the fees be variable at any time during the study or across studies.

Study Fees-

Setup Fee Form and Reporting Needs(Per Study)

The following questions will help determine the customization necessary for per-study setup fees and pertinent data collection.

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Overview:

Since the deployment of a financial management component in StudyTRAX depends heavily on the customers needs, the following will explain the universal components included for each institution.

Projects needed:

Administrative Financing Master

  • Subject Variable Group:  Address and additional contact information for the sponsor(s).  Custom Sponsor related information.
  • Encounter Variable Group:  A form which captures per-study setup fee information, with built in summations for grand total.
  • Intervals: A single Non-Fixed encounter called "study setup".
  • Reports:  Invoice per study setup, as well as a potential invoice that rolls up across studies.

Financial Management Master

  • Subject Variable Group: N/A
  • Encounter Variable Group:  A form which captures universal study events, with customizable pricing and dependent driven summations.
  • Intervals:  A dummy invoicing interval with the purpose of driving the study event defaults for each interval added to the study.
  • Reports:  Patient Level invoice for each visit.  For each patient enrolled, an optional summary invoice across all visits.