Subject Level 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.
- 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)
- Will invoicing be needed at the individual visit (and/or) as a summary across visits?
- 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)
- 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.
- Is it common for study event fees to vary across studies?
- 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.
- Are there any "one-time" per-study fees applicable from one patient to the next?
- Will there be a pre-determined stipend for patients involved in the study, or will patient stipends vary at each individual visit?
- During the collection process, will any one study event fee need custom modification at the time of the visit?
- 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 Level Fees-
Setup Fee Form, Sponsor invoicing and Reporting Needs(Per Study and Across Studies)
The following questions will help determine the customization necessary for per-study setup fees and pertinent data collection.
- What are the standard fees applied to each study startup?
- How and when will these standard fees vary from study to study?
- Will the setup invoice need to be modified after the study budgeting is determined? In most scenarios, setup fees should be finalized prior to study event budgeting.
- Is there a need for invoicing for across studies per sponsor? If so, what are the triggers for this to occur. (e.g. annual invoice)