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Brief title: RASCAL PT-TrakID #:
What's this?
Location: Columbia University IRB #:
Dept chair:
Principal Investigator
UNI: Name:
Telephone: Cell or pager: E-mail:
Clinical Coordinator
UNI: Name:
Telephone: Cell or pager: E-mail:


1. Funding: Is the research sponsored (either directly or with flow-thru funds) by either federal, state, or local government?

(If "Yes", go to question 8. Otherwise, go to question 2.)
No Yes
2. The following questions relate to clinical trials and drug or device studies only.
2a. Is the research a clinical trial being done for FDA approval for marketing of a new drug, or for the approval for a new indication for an already-approved drug? No Yes
2b. Will the research provide direct benefit to the participants that would not be available outside of the research?

If the answer to "2a" is "Yes" and "1" is "No", go to Number 8.
If the answer to "2a" is "No", go to Number 3.
No Yes
3. Does the work require scientific expertise on the part of the Columbia University Investigator as opposed to repetitive work or routine testing? No Yes
4. Does the testing add knowledge within a scientific field (verses testing for quality control for certification purposes)? No Yes
5. Is the research scientific in nature?

Check "Yes" if EITHER question 3 or question 4 is "Yes".
Otherwise check "No".
No Yes
6. Is the scientific research conducted for the public interest (complete items 6a through 6e)?
6a. Research results will be made available to the public? No Yes
6b. Research aids in discovering a cure to a disease? No Yes
6c. Research aids in developing or retaining industry in the area / community? No Yes
6d. Research is directed toward benefiting the public? No Yes
6e. Research aids in scientific education of university students or house staff? No Yes
7. If any item within Number 6 is marked YES, please provide a brief statement explaining "WHY" or "HOW" the research is scientific and in the public interest. (Please do not describe what the research is).
8. Thank you for your time and efforts in completing this form.

I understand that this form is used as a decision tool to help distinguish whether sponsored research activities are related or unrelated taxable business income. I also understand that the initial decision regarding the classification of the sponsored research will be made relying upon the conveyed through this form. However, the decision made could be refuted by the IRS. I certify that all information provided above is accurate and complete to the best of my knowledge.
Disagree Agree
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