FM - New Study Steps

Owned by john Putzke
Last updated: Jan 12, 2012 by Former user (Deleted)Version comment

Procedure Contact:  Budget Manager

Topic:  For the anticipated studyXXXXXX, create the associated Setup fees using the Administrative Setup Project.

Step #1:  Determine if this study is associated with an existing sponsor in the system, or, if a new sponsor must be created.

Step #2:  Create the Study Setup Fees

Topic:  Create a Budget for the anticipated study using the Master Budget Template spreadsheet. (put in link to spreadsheet)

Step #1:  Open the latest YYYYMMDD_Master Budget Template.xls spreadsheet, Rename and Save As StudyXXXXXX.xls.

Step #2:  Using the StudyXXXXXX.xls spreadsheet, modify (or) remove the number of columns, and rename the intervals(Encounters) per the study.

Step #3:  Use a Dark Gray Background Shade and color the rows that are not applicable at any interval in this study.

Step #4:  If necessary, adjust the default pricing rates where it makes universal sense .  (e.g. if a majority of the prices are different from the default rate, in any one row.)  Use a Dark Red Background Shade and color the default pricing rate cells, when a change is applied.

Step #5:  Begin adding pricing amounts to each cell where applicable to the budget.

Action:  Notify Study Administrator and await notification that StudyTRAX Financial Master has been updated in StudyTRAX.

Step #6:  Update Master Budget Template spreadsheet

Procedure Contact:  Study Administrator

Topic:  Upon receipt of the StudyXXXXXX.xls spreadsheet, Create a new study utilizing the financial component.

Step #1:  Click on the projects main menu item at the top of the screen.  Determine if Default price rates need to be updated.

Step #2:  A new study is created as a copy of the Financial Management Master.

Step #3:  Update the pricing of each interval according to the budget.

Step #4:  After all intervals are adjusted as necessary, double check your work.  When ready, delete the "Invoicing" interval.

Step #5:  Review the Unstructured Event Encounter

Next actions:  [ The Study Administrator is now ready to confirm with the Budget Manager that the Master Budget Template has been modified in StudyTRAX according to the StudyXXXXXX.xls spreadsheet template.   The financial components for this study have been implemented ]

  • At this point, the study can be developed with the appropriate CRF's as normal.  Patients can be enrolled into the study per the protocol.

NOTE:  As the study proceeds, when necessary, adjustments to the study pricing at any one subject encounter can be accomplished.