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Contractual Agreements for Device Studies-Subject Injury Lynne M. Pecze 15 Mar 1996 17:33 EST

In our drug study agreements, we have been successful in having the company
agree to cover all reasonable expenses related to subject injusry.  I have
been recently negotiating some device agreements, however, and reimbursement
is limited to a clinical limited warranty  plus free replacement of the
device which we do not feel will cover all of the costs.  We have
successfully worked with one company to expand their reimbursement, but are
meeting a lot of resistence from a second company.  I would really
appreciate any feedback regarding what wording your institution finds
acceptable since I have not worked with many of these types of agreements.