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  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.

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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.

  1. What are the standard fees applied to each study startup?
  2. How and when will these standard fees vary from study to study?
  3. 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.
  4. 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)