Fred Hutchinson Cancer Research Center

Industry Sponsorship Formpage 1

Industry Sponsorship Form

Date: / Protocol #:
Name of Study: / IRB/IACUC File #:

Complete the following information and forward this form with your sign-off materials. Please attach a copy of the Protocol or Scope of Work and Budget for the Study.

Center Information

Principal Investigator:
Co-investigators:
P.I. Mailstop: / P.I. Telephone: / P.I. Facsimile:
Budget Coordinator/Project Manager:
Mailstop: / Telephone: / Facsimile:

Sponsor Information

Sponsor Name:
Technical Contact Name:
Address:
Telephone: / Facsimile: / E-mail address:
Business/Legal Contact Name:
Address:
Telephone: / Facsimile: / E-mail address:

Study Description

Is this a Sponsored initiated Study or PI initiated Study?
Is there an IND? / Yes / No / ListIND#:
Is there an IDE? / Yes / No / List IDE#:
If so, who holds the IND or IDE:
Has the FDA approved a waiver? / Yes / No
If so, please attach a copy of the written waiver.
What is the Sponsor providing? (Check all that apply)
Drug or Other Materials: / Funding: / Other:
Give the name of any drug, biologic or device being tested in the study:
Is it commercially available? / Yes / No
Is this an approved use or off-label use of the drug, biologic or device?
Is this Study being done to support the Sponsor's efforts to obtain approval of the drug, biologic or device from the Food and Drug Administration or similar government agency? Yes No

Patient Information

Where will the patients be treated for research related activities (other than standard of care)?
Has the Sponsor agreed to pay for study related injuries? / Yes No
Has the Sponsor agreed to pay for any items not covered by third party insurance? / Yes No
If so, what:

Type of Activity(Check one)

Data or sample collection / Epidemiological study
Minor data analysis / Major statistical study
Case report abstraction / Basic research
Clinical or Prevention trial
Phase I
Phase II
Phase III
Expected start date:
Expected duration:

Intellectual Property

What is the likelihood that there will be an invention or discovery arising from the Center’s activities in connection with this Study? (Check one)
High: / Moderate: / Low:
Does this study involve a pre-existing drug, biologic, method, software or device developed at the Center?
Yes / No
If Yes, has this been report to Tech Transfer?
If No, please contact Tech Transfer and, describe the invention or discovery, including a description of any related patent, patent application or license:

(Please attach separate page if necessary)

Deliverables

What deliverables will the Sponsor receive in connection with the Study?
Will the Sponsor receive human specimens collected by or under the control of the Center?
Yes / No

Capital Equipment

List any equipment that will be transferred or donated to the Center in connection with the Study.

Scientific/Budgetary Overlap with Other Study

Is this Study supported in whole or in part by funding or other support from any other source?
Yes / No
If yes, please identify any other source of support: (Attach an additional sheet if necessary)
Agency or Company Sponsor: / Program Budget #:
P.I.: / Type of Support:
Drugs or Other Material / Funding / Other
What patient related expenses are covered by this Agency or Company Sponsor?
Is this study funded by an agreement with another institution (UW, Children’s)?
If so, where?

Investigator Statement and Signature

The above information, to the best of my knowledge, accurately reflects the extent of commercial involvement in this project.

Principal Investigator Signature

Date