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DRUG STUDY QUESTIONNAIRE PROGRAM DIRECTOR:______________________________________ DATE:_____________________________
 

Summary: DRUG STUDY QUESTIONNAIRE
PROGRAM DIRECTOR:______________________________________ DATE:_____________________________
DEPARTMENT:_____________________________________________ ACCOUNT CODE:___________________
SPONSOR:________________________________________________ SPONSOR NO:_____________________
YES NO
1. Is the testing, study, evaluation or research for the safety and/or efficacy of a drug?
A. If yes, is the testing, study, evaluation or research primarily for use in pharmaceutical
pre-market clearance applications to the Food and Drug Administration?
2. Is drug administered to patients with a disease for which the drug is intended to treat?
3. Are healthy volunteers infected and then used to evaluate the effectiveness of the drug?
4. Does the drug study involve new applications of products or drugs in order to improve the
ability to treat varoius diseases and conditions?
5. Does the private industry sponsor have the right to all results and patents stemming from
the project?
6. Does the private industry sponsor have the right to delay publication of the test results?
7. Is publication of test results or research available to the public on a nondiscriminatory
basis?
8. Is the testing, study, evaluation or research carried on for the purpose of obtaining
scientific information which is published in a treatise, thesis, trade magazine or any other
form that is available to the "interested" public?

  

Source: Acton, Scott - Department of Electrical and Computer Engineering, University of Virginia

 

Collections: Computer Technologies and Information Sciences