Electronic Submissions Only
irb@kdhcd.org
Email subject line must
have the study’s IRB #
Use of Drugs or Biological Products
PI Name: Click here to enter text.
Date: Click here to enter a date.
Project Title: Click here to enter text.
Appendix E – Use of Drugs or Biological Products




Researchers planning to include approved or unapproved drugs or biological products in research projects
must complete this form.
Complete Appendix E for each Drug or Biological Product
Researchers are reminded that the word “experimental” or “investigational” must appear in the consent
form to modify the drug names. (Reference 21 CFR 312).
Research involving drugs/biologics is not eligible for expedited review
Section 1: Identification of the Drug or Biological Product
Trade name of Drug of
Biological Product
Click here to enter text.
Generic Name (if drug) or
Biological Name
Click here to enter text.
Manufacturer of the product to
be used in this study
Click here to enter text.
1.1 Is this drug considered a controlled substance?
☐Yes ☐No
1.2 Is this a combination product as defined by FDA (i.e. drug delivery method involved use of an
unapproved device or FDA approved device which could significantly increase risk to subjects)?
☐Yes ☐No
Section 2: Regulatory Status of the Drug/Biological Product
2.1 Check the box next to the description of the current IND status. If IND has been assigned or
pending answer the additional questions below.
Section Complete – go to Section 3
Investigational New Drug
☐No IND Number (neither pending nor assigned)
Requirements/Exemption
Expected date of receipt of documentation:
Click here to enter a date.
☐An IND number is PENDING (an application has
Who will hold the IND?
been submitted to the FDA
Click here to enter text.
Enter the IND Number:
Click here to enter text.
☐An IND number has been assigned
Who holds the IND?
Click here to enter text.
2.2 If an IND number is either pending or assigned, please indicate which of the following will be
submitted to the IRB as validation of the IND Number:
☐Written Communication from the sponsor
Appendix E
Use of Drugs and Biological Products
Page 1 of 4
Electronic Submissions Only
irb@kdhcd.org
Email subject line must
have the study’s IRB #
Use of Drugs or Biological Products
☐Written Communication from the FDA (required for investigator held INDs)
☐Sponsor protocol imprinted with IND Number
NOTE: A copy of the Investigator’s Brochure, package insert, or a copy of the Chemistry, Manufacturing
and Control section of the sponsor-investigator’s IND application must be submitted with the IRB
application.
Section Complete. Go to Section 4 – Drug Management and Accountability.
Section 3: Investigational New Drug Requirements/Exemptions
Under FDA regulations, research that involves use of a drug other than the use of a marketed drug in the
course of medical practice, must have IND, unless the study meets one of the exemptions for the IND
requirement at 21 CFR 312.2(b). Complete the following to document that the study is being conducted
under a valid IND or the study is exempt from IND requirements.
3.1 Check the box indicating whether statement A, B, or C applies
This study involves Approved Use (per approved labeling) of FDA Approved
Drug(s). Use must not involve a route of administration, dosage, patient
population or other factor which significantly increases risks, or decreases
acceptability of the risks, and; the results are not intended to be reported to
☐Statement A
FDA in support of a change in labeling/marketing
The FDA approved package insert for the product must be submitted with
the IRB application. Go to questions 3.2
The investigator has obtained/will obtain documentation from the sponsor
or FDA to confirm the study is Exempt from IND requirements [21 CFR
312.2(b)(i)]
☐Statement B
NOTE: the final approval will not be granted until documentation is provided
to the IRB Go to Question 3.2
The investigator, absent a ruling from FDA, believes the study meets
Exemption Category 1: Approved Drug for Unapproved Use.
☐Statement C
Complete the Exemption Category 1 Worksheet below
Exemption Category 1 Determination Worksheet
Is the drug lawfully marketed in
the United States?
Are you or your funding source
intending to report the study
results to the FDA to support a
new indication or labeling
change?
Appendix E
☐Yes ☐No
If “No”, the criteria for
exemption is not met
☐Yes ☐No
If “Yes”, criteria for exemption
is not met
Use of Drugs and Biological Products
Page 2 of 4
Electronic Submissions Only
irb@kdhcd.org
Email subject line must
have the study’s IRB #
Use of Drugs or Biological Products
Are you or your funding source
intending to report the study
If “Yes”, criteria for exemption
☐Yes ☐No
results to the FDA to support a
is not met
change in the advertising?
Does the planned use of the
study drug involve a change in
If “Yes”, criteria for exemption
route of administration, dosage
☐Yes ☐No
is not met
level or use in a patient
population?
Does the planned use of the
study drug significantly increase
the risks (or decrease the
If “Yes”, criteria for exemption
☐Yes ☐No
acceptability of the risks)
is not met
associated with the use to the
subjects being studied?
Is the research conducted in
compliance with the marketing
If “No”, the criteria for
☐Yes ☐No
limitations described in 21 CFR
exemption is not met
312.7?
3.2 Does the protocol involve any of the following? Select all that apply.
☐In-Vitro Diagnostic
☐Cold Isotopes
☐Endogenous Compounds
☐Bioavailability or Bioequivalence Studies
☐Live Organisms
☐Combination (drug/device) products
☐Other products intended to evaluate ability to
diagnose, cure, mitigate, treat or prevent disease
☐Dietary supplements, botanicals, or other
substances designated as generally recognized safe
(GRAS) for use in food
☐Positron Emission Tomography (PET) drugs
☐None apply
If the protocol involved any of the above and the researcher is claiming exemption from an IND, be
aware that the FDA has very specific criteria which must be met. The IRB requires the PI to provide
documentation of occurrence from the FDA.
Section 4: Drug Management and Accountability
All drug and biological product studies must, at a minimum be registered with the Investigational Drug
Service (IDS). This is true whether or not the drug or biological product is approved or not. The
number assigned by the Investigational Drug Service must be submitted to the IRB in order to receive
final approval for this study.
4.1 Is the IDS Pharmacy dispensing study medication?
Provide the IDS Number:
☐ Yes
Click here to enter text.
Provide the IDS RO (Registered Only) Number:
☐ No
Click here to enter text.
Appendix E
Use of Drugs and Biological Products
Page 3 of 4
Electronic Submissions Only
irb@kdhcd.org
Email subject line must
have the study’s IRB #
Use of Drugs or Biological Products
Who will dispense the study medication?
☐Study medication(s) will be dispensed by physician
-OR☐ Study medication(s) is/are all commercial medications and will be dispensed by a
licensed pharmacy
Section 5: Special Considerations for Investigator Initiated Research
Sponsor-investigators are required to complete the web-based Good Clinical Practice Course available
through the Collaborative Institutional Training Initiative (CITI). This course provides guidance on the
regulatory and institutional responsibilities of the sponsor-investigator role in drug studies. This
training must be successful completed before IRB approval is granted.
5.1 Is this study investigator initiated (the PI is initiating and conducting, either alone or with others, a
clinical investigation)
☐Yes ☐No. If “No”, this section is complete
5.2 Provide the date (Month/Year) the PI completed the required CITI course for sponsorinvestigators.
Click here to enter a date.
5.3 Has the PI transferred any sponsor obligations/responsibilities to the commercial sponsor, Kaweah
Delta Health Care District, contract research organization, or other entity?
☐ Yes, indicate roles and responsibilities being transferred ☐ No
Click here to enter text.
5.4 Explain how monitoring the conduct of the clinical investigation, and reviewing and evaluating
safety information will be performed, and by whom:
Click here to enter text.
5.5 Check the boxes next to the statements below to confirm understanding and agreement:
☐The Principal Investigator confirms he/she is aware of the regulatory responsibilities as a sponsorinvestigator
☐The Principal Investigator confirms he/she will comply with Kaweah Delta Health Care District Policy
for use of devices in research
Appendix E
Use of Drugs and Biological Products
Page 4 of 4