Jacksonville – IRB-03
Make sure your Microsoft Word program is set to display “Hidden Text”. This document contains helpful information, examples, and instructions that are only visible (and will never print) when the “Hidden Text” feature is enabled. “Hidden Text” will be displayed highlighted yellow, italics, and underlined. Go to the “Tools” menu, “Options”, on the “View” tab make sure “Hidden Text” has a check mark, and click “OK”.
The questions below apply to the use of drugs, biological agents,chemicals or other non-food substance. Answer all of the questions if you are using one of these items.
Project Title:
1. This study is (check whichever is appropriate):
Industry sponsored and the local investigators do not hold an IND for any of the test articles.Please attach documentation from the sponsor or FDA that addresses the use of all drugs/substances being used showing either the FDA’s IND number or that the substances are IND exempt.Industry sponsored research may be eligible for or require review by IRB-04 (WIRB®). Please see
Addendum C: Drugs, Biologics, or other SubstancesPage 1 of 2
IRB Version: 11/24/2009
PI Version:
Addendum C: Drugs, Biologics, or other SubstancesPage 1 of 2
IRB Version: 11/24/2009
PI Version:
or call our office for assistance.
Study is sponsored by non-industry source (e.g. a national cooperative group) and the local investigators do not hold an IND for any of the test articles. Please attach documentation from the sponsor or FDA that addresses the use of all drugs/substances being used showing either the FDA’s IND number or that the substances are IND exempt.
Study initiated by local investigator regardless of funding source but no IND pending or obtained. IND may be required.
Local investigator already holds or is seeking to hold IND(regardless of funding source). Documentation from the FDA is required.
Other. Please describe:
2. List the drugs/substances to be studied:
3. Does this study involve the use of FDA approved drugs/substances in a manner that is consistent with the FDA’s previous approval (approved route, indication, and population)?
No. Go to Question 4.
Yes. Attach a copy of one or more of the following:letter from sponsor indicating that the study articles are being used only in their previously approved manner;Investigator’s Brochure; package insert; or other supporting documentation that describes the approved use for the drug/substance, etc. Answer Questions 3.a. and 3.b.
3. a. List the approved drugs/substances being used in an approved manner:
3. B. Are these drugs/substancesbeing used in a manner that is similar to the standard medical care these subjects would receive if they were not on the study?
Yes.
No. Explain:
4. Does this study involve the use of FDA approved drugs/substances in a manner that is not consistent with the FDA’s previous approval (approved route, indication, and population)?
No. Go to Question 5.
Yes. (i) Explain:
(ii) The FDA may require the investigator or sponsor to obtain an IND number. Check each of the following if applicable:
Provide the drug names & IND number(s) . Attach documentation (from the sponsor, FDA, etc) that indicates the IND number(s).
Attach a copy of a letter from the FDA indicating an IND is not needed,
Attach documentation from the sponsor certifying that the use is IND exempt.
1571 form sent to FDA for determination of whether or not an IND is required. Response from FDA pending and will be forwarded to the IRB upon receipt. Addendum C(this form)will need to be corrected at that time to indicate the correct information (either provide the IND # or letter indicating one is not needed).
5. Does this study involve the use of drugs/substances that have not been approved by the FDA?
No. Go to Question 6.
Yes. The FDA may require the investigator or sponsor to obtain an IND number. Check each of the following if applicable:
Provide the drug/substance names & IND number(s). Attach documentation (from the sponsor, FDA, etc)that indicates the IND number(s).
Attach a copy of a letter from the FDA indicating an IND is not needed. This can be obtained by submitting the FDA’s 1571 form, along with the required supplemental information, to the FDA.
Attach documentation from the sponsor certifying that the use is IND exempt.
1571 form has been sent to FDA for determination of whether or not an IND is required. Response from FDA pending and will be forwarded to the IRB upon receipt. This form will need to be corrected at that time to indicate the correct information (either provide the IND # or letter indicating one is not needed).
NOTE 1: IRB-03 does not determine if test articles meet FDA IND exemption criteria as defined in 21 CFR 312.2.(b). IRB-03 requires investigators to submit either (a) a letter from the sponsor indicating the test articles meet the exempt criteria or(b) a 1571 form to the FDA to insure an IND is not required, in which case if the FDA does not require an IND, the investigator must contact the FDA and receive such permission in writing (the FDA will only provide a letter upon request).6. Will any drugs/substances be provided to the subject at no cost?
No.
Yes. (a)Please describe what will be provided at no cost to the subject:
(b) Who will provide the drugs/substances at no charge?
(c)Please describe if there are any plans to make the drugs/substances available to subjects once their participation in the study is complete and if so what the anticipated cost will be:
Additional information about using drugs, biologics, and other non-food substances, including how/who to contact at the FDA, can be found at:
Addendum C: Drugs, Biologics, or other SubstancesPage 1 of 2
IRB Version: 11/24/2009
PI Version: