Contractual Requirements & Guidelines

	Contractual Requirements
	Contractual Guidelines
	Financial Guidelines
	Execution of Confidential Disclosure Agreement
	Master Agreements

Contractual Requirements

The CCS negotiates all agreements for trials conducted at Washington University and its affiliated hospitals, with no charge to the investigator. The information listed here is intended to provide the Clinical Investigator with an understanding of the contractual issues which must be addressed in these agreements.

 The following Contractual Requirements reflect School of Medicine policy:

• The sponsor must provide full indemnification for the performance of the study and the University requires full protection from any third-party commercialization claims from the sponsor or the funding source of the clinical study.
• The Sponsor must provide evidence of adequate insurance to cover its indemnification promise. 
• The Investigator's ability to publish must be protected. 
• Washington University must be a party to the agreement. Only a properly designated person may sign a contract on behalf of the University.
• All payments from the Sponsor should be made payable to WASHINGTON UNIVERSITY and sent to:

Washington University
Center for Clinical Studies
660 South Euclid Avenue - CB8009
St. Louis, MO 63110
Tax ID: 43 0653611

(Study # and PI name should be indicated on check stub.)

Questions regarding the contract should be addressed to:
Melanie Roewe, J.D.
Campus Box 8009
IWJ, Room 301
tel: 314-362-6988
fax: 314-747-1404
email: roewem@msnotes.wustl.edu

Supporting documentation regarding the contract should be addressed to:
Beth Blumfelder
Campus Box 8009
IWJ, Room 301
tel: 314-362-6953
fax: 314-747-1404
email: ccscontracts@msnotes.wustl.edu

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Contractual Guidelines

Financial Guidelines

The following financial guidelines will help ensure reasonable remuneration for the study:

• The Budget must include the appropriate overhead rate. Please contact a CCS Contract Specialist for the appropriate overhead rate before negotiating a budget with a Sponsor.
  
• Our institution has an IRB initial and continuing review fee (plus the appropriate overhead) that needs to be included in the budget. As of July 1, 2008 the initial fee is $2,000 (plus the appropriate overhead) and a continuing review fee (Full Board) of $1,250 a year (plus the appropriate overhead).
  
• Progress payments should be requested, with an initial payment sufficient to cover start up costs. Normally the IRB fee plus 20% -25% of targeted budget is required.
  
• The agreement should provide payments for screen failures and drop outs.
  
• The budget for the clinical study is to be prepared on a cost per patient, cost per procedure, or fixed price basis. The IRB fee, and pharmacy initiation fee should be listed separately and not calculated on a per patient or per procedure basis. A clinical study budget should not list a percentage of effort similar to a grant proposal.
  
• The department business manager should be consulted to determine if there is departmental overhead for the study.

Execution of Confidential Disclosure Agreement

Washington University has negotiated a number of Master Agreements. Please review the list to determine whether your study is sponsored by one of these companies. If it is the CCS can quickly negotiate a letter agreement under the Master Agreement, thereby reducing the time required for contract negotiation. The process may be further expedited if the investigator informs their contact at the company of the existence of the Master at the time they decide to conduct the study.

Alexion Pharmaceuticals Inc. American College of Radiology (ACRIN) Amgen Bayer Corporation Biogen Inc. Bristol-Myers Squibb Pharmaceutical Research Institute Co Censys Cook DuPont Eli Lilly and Company G.D. Searle & Co.

Genzyme Guidant Hoffman-La Roche Inc. Mallinckrodt Inc. Medtronic Inc. Merck & Co. , Inc. Novartis Pharmaceuticals Corporation Pfizer Inc. Roche Laboratories Inc. Schering-Plough Wyeth

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