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Appendix J
USE OF FDA-APPROVED DRUGS AND INVESTIGATIONAL DRUGS OR BIOLOGICAL
PRODUCTS IN CLINICAL INVESTIGATIONS
Please read the applicable HRP webpage for information about the use of drugs or biological products in clinical
investigations.
This appendix is for studies that involve the use of FDA-approved (marketed) drugs or unapproved drugs or
biological products in clinical investigations. Documentation of FDA approval for the use of investigational drugs
or biological products must be provided for IRB review and before IRB approval may be granted.
1. Identify the drug(s) or biological product(s) to be used in this study:
a. Trade Name/Biological Product (e.g., Tylenol):
b. Generic Name (e.g., acetaminophen):
c. Manufacturer (e.g., McNeil):
2. Provide a summary in each section (a-g) below for the drug(s) or biological product(s) listed above.
a. Product Description:
b. Clinical Pharmacology:
c. Indications and Usage:
d. Dosage and Guidelines for Administration:
e. Toxicity and Known Side Effects:
f.
Precautions and Contraindications:
g. Provide the following information from the Investigator’s Brochure, package insert, or other
materials indicating where additional information about the drug(s) or biological product(s) can be
found. Also, upload the document(s) to the e-IRB Application.
a. Section Title:
b. Page numbers:
3. Does the drug or biologic have an Investigational New Drug (IND) Number?
Yes (answer question 4 below; skip questions 5, 6 and 7)
No (skip question 4; answer questions 5 and 6 below)
4. Provide the following information about the IND: (NOTE: Researchers must provide documentation of a
valid IND number prior to IRB approval. If the study is not externally funded or a UCI investigator holds the
IND, a copy of the FDA IND Application is required prior to IRB review.):
a. IND Number:
b. IND Filing Date (mm/dd/yy):
c. Holder of the IND
Lead Researcher (Specify):
Study Sponsor
Other (Specify):
d. Does the IND allow billing of subjects?
Yes
No
e. Please indicate the phase(s) of the study, if applicable:
Phase I
Phase II
Phase III
Phase IV
Not Applicable
f.
Public Law 110-85 requires registration of clinical trials. The International Committee of Medical
Journal Editors (ICMJE) also requires registration of clinical trials in order for results to be
published in member biomedical journals. Additional information, including guidance on the UCI
registration process for ClinicalTrials.gov at UCI, can be found on the HRP page, Guidelines for
Registering with ClinicalTrials.gov. Clinical trials are required to be registered before the
enrollment of the first subject, but not prior to IRB approval.
Please select one of the following:
This is not a clinical trial; registration not required
Registration Pending
ClinicalTrials.gov “NCT” number for this trial:
5. Is the drug or biologic FDA approved and being used according to the approved labeling?
Yes - Briefly describe the FDA approved labeling and indicated use:
No - Indicate why an IND is not required:
6. Has the FDA reviewed an IND submission and determined that an IND is not required?
Yes (Skip Question 7. Be sure to upload the FDA determination letter.)
No
7. Please answer the following questions to determine whether "off-label" use of an approved FDA drug
or biological product requires filing of an IND.
Note: The clinical investigation of an approved, marketed drug or biological product requires consideration of
whether an IND is required. When the principal intent of the investigational use of a test article (drug,
biological product) is to develop information about the product's safety or efficacy, submission of an IND is
required.
If you answer “yes” “yes” to any of the following criteria, an IND must be filed with the FDA:
a. Are you or your funding source intending to report the study results to the FDA to support a new
indication of labeling change?
Yes
No
b. Are you or your funding source intending to report the study results to the FDA to support a change in
the advertising?
Yes
No
c.
Does the planned use of the study drug increase the risks or decrease the acceptability of the risks to
the subjects being studied?
Yes
No
d. Does the study require any change in the approved formulation, dosage, or route of administration of
the drug?
Yes
No
e. Cancer therapies only: Does the study involve new combinations, new schedules or new routes of
administration of the drug?
Yes*
No
* An IND is not required if this is the only box checked "Yes."
8. Are investigational drugs or biologics controlled by a UCI Pharmacy?
Yes (Skip this section)
No
Provide the following information about how the drug/biologic will be managed and controlled:
a. Describe your plan to ensure that the investigational drug/biologic is used only in accordance with the
UCI IRB approved protocol:
b. Describe who will access to the drug/biologic and how access will be controlled to secure the
drug/biologic:
c.
Specify how records for control of the drug/biologic will be recorded.
The sample Drug/Biologic Accountability Log on the HRPP website will be used.
The Drug/Biologic Log provided by the Sponsor will be used (be sure to attach this to the
application).
No log will be used (specify why not):
d. Specify whether investigational drugs or biologics are prepared or manufactured in UCI research
labs.
Yes (If yes, identify the lab):
No