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As part of the Clinical Trials Transformation Initiative, The Clinical Trials Support Office (CTSO) and Clinical Research Calendar Review & Analysis Office (CRAO) have partnered to document financial best practices, gather resources and develop the tools that will support the following goals :

Optimize and standardize the process of cost recovery and related negotiation practices in order to support operational excellence throughout the life cycle of clinical trials


Address bottlenecks that prevent timely initiation of clinical trials and increase the ability of University of Michigan clinical researchers to compete with peer institutions in trial initiation and recruitment, with the ultimate goal to enhance the culture of clinical research


Eliminate waste and reduce administrative burden for faculty, finance staff and study coordinators





Many thanks to Dr. Lok for all of her help in developing and coordinating the many facets of this knowledge base.


This resource would also not be possible without the incredible help of our collaborators from a variety of departments and units. Sincere thanks to all of you who shared the examples, documentation and knowledge that are the meat & potatoes of this knowledge base, including Kate Hoffman, Mariella Wells, Amy Oliver, Marilyn Cramer, Linda Beekman and the entire CRAO team.

Please note that knowledge base access is restricted by default; to request access, report an issue, submit feedback or just say hi, please direct all correspondence to thefunk-admins@umich.edu . Thank you!

  Looking for something specific?

We recommend using the search box below ( this will limit your search to the Knowledge Base, while the search bos in the upper right corner of the page will return results from any / all confluence spaces ) :

   

  Information and resources are grouped into three main categories :

  A. Best Practice Presentations

The Basics : Slides and supplemental materials pertaining to the three-part 'Best Practices' training sessions, offered for CTSU Administrators, Financial Personnel and Study Coordinators over the course of the summer ( 2016 ); see the brief summaries below for additional details on content covered in each presentation

  B. Justification Guidance and Standard Definitions

A library of standard justifications for common / anticipated budget line-items or expenses, provided as a resource to facilitate the negotiation process. Rate suggestions are given as a jumping-off point for budgeting.

  C. Case Studies and Historical Justification Documents 

Further reading for those who wish to drill deeper into the nuances of the sponsor negotiation process. Each case study is an email chain beginning with the initial UM-sponsor contact for a specific trial and ending with a successfully negotiated budget. Helpful for anyone interested in the ebb and flow of the negotiation process, how specific rebuttals have been used to push back on sponsors with success, common clarifications requested by sponsors, odd situations that come up, etc.


  Additional Nav Tools

  Quick Links and FAQs

  Site-Map & Search 



I. Protocol Analysis & Billing Calendar Training

Training session originally presented by CRAO on 6.2.16.

Follow the link for presentation slides, as well as supplemental details, examples and other resources. if there are questions about any of this information, please don't hesitate to contact CRAO for clarification. 

II. Budget Creation, Negotiation and Finalization

Training session originally presented by CRAO on 6.22.16.
 
Follow the link for presentation slides, as well as supplemental details, examples and other resources. if there are questions about any of this information, please don't hesitate to contact CRAO for clarification.

III. Award Management

Training session originally presented by CRAO on 7.27.16. 
 
Follow the link for presentation slides, as well as supplemental details, examples and other resources. if there are questions about any of this information, please don't hesitate to contact CRAO for clarification. 





A library of standard justifications for common / anticipated budget line-items or expenses, provided as a resource to facilitate the negotiation process. Rate suggestions are given as a jumping-off point for budgeting, and each entry includes notes, tips and advice regarding usage / other factors to consider when budgeting and negotiating. Entries are grouped into one of the following categories :

  • Other Invoicable Fees : Other considerations that will be applicable on a case-by-case basis; includes the ever-important screen failure line-item ( beware of screen failure caps! )
  • Study Visit Costs : Costs that factor into each visit total as well as the overall per-patient amount





Further reading for those who wish to drill deeper into the nuances of the sponsor negotiation process. Each case study is an email chain beginning with the initial UM-sponsor contact for a specific trial and ending with a successfully negotiated budget. Helpful for anyone interested in the ebb and flow of the negotiation process, how specific rebuttals have been used to push back on sponsors with success, common clarifications requested by sponsors, odd situations that come up, etc.




Roles & Responsibilities : A Comprehensive Overview

A task-list that provides helpful detail to consider when determining specific staff responsibilities, calculating effort or determining study logistics.

Where can I find an internal budget template?

A current (suggested) template can be downloaded from the Budgeting Tools & Tips page

Resources Galore

A wide selection of links to relevant details housed on other University sites (ORSP, FinOps, MICHR, etc.)

Beware of Screen Failure Caps!

Sponsor insisting on a screen failure cap?This case study illustrates how to work with the sponsor to reach an agreement amenable to everyone.

Indirect Costs

ORSP's page on indirects ( also known as Facilities & Administrative,  F&A, or IDC ) features a comprehensive overview as well as current rate information.

Budget Tools, Tips & Templates

Resources for effort calculation, CPT selection and more

Account Reconciliation Help and Charge Correction Overview

Advice from the CRBI ( Clinical Research Billing Issues ) experts

Q. How often should a study account be reconciled?
A. On (at least) a monthly basis

Need help getting started / un-stuck? Check out the Clinical Research Billing Issues (CRBI) team's latest  reconciliation recommendations and handy tips for navigating MiChart here, or contact the experts directly @ CRBIssues-help@med.umich.edu



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