Definition here. |
This tool is intended to assist the researcher in determining whether or not a particular study will need an IND, as well as to educate the researcher about factors that influence this decision.
Disclaimer: The IND Decision web-tool is meant only as a support tool. It displays the most likely decision based on your answers to the questions posed, but is not a guarantee that you do or do not require an IND for your study.
You may re-run the decision tool as often as you'd like, which may be helpful in understanding the logic behind the conclusion of whether or not to file an IND.
Do not use the BACK button of your browser, as this will invalidate the results. |
Instead, use the "Re-run the IND Decision Support Tool" link on the results page, or use the "IND Decision Tool" link on the left navigation bar to start over.
You will be presented with a number of questions about your study. On each page, definitions of the terms used are provided whenever the term is highlighted yellow, as in This Term. When you see a term highlighted in yellow, move your mouse over the term and a definition will appear in the white box.
You are required to select at least one choice for each question before proceeding. The questions you will be presented with will vary according to your answers. The choices you made will accumulate and be displayed to you in the resulting page, indicating whether or not you need to file an IND.