Principal Investigators are responsible for properly administering the contractual and financial obligations of their clinical research projects.  These elements of administrative responsibilities include:

• Compliance with the Contractual terms
• Proper budget development for the costs associated with the trial  (The clinical trials office maintains a procedure cost list for patient costs associated with clinical research. 
• Completing the appropriate internal requisition form called a SPAF Form
• Financial management of the funds during the conduct of the trial
• Reconciliation of the Funds at the conclusion of a study

Mandatory Pre-Study Support Services- The investigator must work with the following offices when developing a research project

For Industry Funded Trials:  The Investigator must work with the Office of Clinical Trials for assistance with Private Industry Contracts and Budget Development Services.  The Office of Clinical Trials will manage the contract negotiations, evaluate and negotiate the budget proposal with the sponsor, establish the procedure costs at the University, and establish an internal grant account number.  At the conclusion of the study start up process the Office of Clinical Trials will disseminate the budget items to the investigator, hospital and practice plan representatives for billing purposes throughout the trial.  The Investigator and their support staff are then responsible for proper financial management of the funds and properly registering patients for study specific procedures during the course of the study.

For Grant Budget Development:  The Sponsored Projects Administration assists with the budget development for government funding proposals and foundation based research.  The Office of Clinical Trials will assist with identifying the correct patient specific costs (if applicable) included in the grant.  However all other budget assistance should be completed in consultation with the Sponsored Projects Administration.

Study Conduct and Reconciliation

The Investigator will work with their research coordinators and financial administrators to ensure appropriate costs and billing is performed throughout the trial.  The financial responsibilities must be properly administered to ensure the grant account is billed properly for study specific costs and patient procedures.  These study specific costs are identified in the budget at the start of a trial and must be properly billed during the conduct of the trial.  Study specific charges that are paid for by the study budget cannot be billed to a patients insurance or to Medicare.

 

Clinical Trial Contract Forms	Link to Blank Form	Miscellaneous/ Sample Form	Link to Policy/Info
University Information to Provide a Sponsor when considering a Trial
Confidentiality Agreement Information
Sample Clinical Trial Agreement Form
Subject Reimbursement Forms
Check Request Form
Cash Handling Policy and Application Forms
W-9 Forms for Subjects to complete
Clinical Trial Budget and Financial Management Forms
SPAF - Sponsored Projects Administration Form
Patient Account Set-Up and Billing Compliance Forms
Patient Billing and Registration Form (Patient Services)-ensure proper patient billing during the study
Hospital Account Registration Form- study start submit to hospital to request account with fee schedule