Human Research Protections
Appendix J – Use of FDA-Approved Drug/ Biologic & Investigational Drugs/ Biologic in Clinical Investigations
Version 04-18-2017
Researchers:
· Complete one Appendix J for each drug / biologic being studied in the clinical investigation.
· This appendix is for studies that involve the use of FDA-approved (marketed) drug/biologic or unapproved drug/biologic in clinical investigations. Documentation of a FDA Investigational New Drug (IND) Application for the use of an investigational agent (drug/biologic) must be provided to the IRB for review and before IRB approval may be granted.
· Please read the HRPP webpage for information about the use of drugs in clinical investigations. / HS#:
(to be completed by the IRB)
Lead Researcher/Investigator Name:
1. Identify the agent to be used in this study:
a. Trade Name/Biologic (e.g., Tylenol):
b. Generic Name (e.g., acetaminophen):
c. Manufacturer (e.g., McNeil):
2. Identify the regulatory status of the agent(s) to be used in this study (select one of the following options (a-d)):
a. The agent is approved by the FDA and will be used according to the FDA label.
b. The FDA has reviewed an IND submission and determined that an IND is not required.
(Provide a copy of the FDA determination letter.)
c. The investigation will be conducted under a valid IND number provided by the sponsor,
CRO or FDA
(Provide a copy of the FDA determination letter if available. Acknowledgement Evidence of the IND number on the Master Protocol serves as a protocol – specific reference and is acceptable evidence of the IND. Note: Researchers must provide documentation of a valid IND number prior to IRB approval. If the study is not externally funded or if a UCI investigator holds the IND, a copy of the FDA IND Application is required prior to IRB review.)
i. IND Number:
ii. IND Filing Date (mm/dd/yy):
iii. Holder of the IND
Lead Researcher (Reminder: the protocol must meet GCP Guidelines):
Study Sponsor/Manufacturer
Other (e.g., NIH, GOG, CTEP):
iv. Does the IND allow billing of subjects? Yes No
d. The investigation meets the exemption criteria under 21 CFR 312.2(b)(1).
(Note: If you answer “yes” to i – iv below, an IND application must be filed with the FDA.)
i. Is the investigation intended to support FDA approval of a new indication or a significant change in the labeling of the agent?
Yes No
ii. Is the investigation intended to support a significant change in the advertising of the lawfully marketed agent?
Yes No
iii. Does the investigation involve a route of administration or dosage level or use in a patient population or other factor (e.g., formulation) that significantly increases the risk to subjects (or decreases study drug increase the risks or decrease the acceptability of the risk) associated with the use of the agent?
Yes No
iv. Is the investigation intended to promote or commercialize the investigational new agent (i.e., make promotional claims of safety or effectiveness)?
Yes No
v. Does the study require any change in the approved formulation, dosage, or route of administration of the agent?
Yes No
vi. For Cancer therapies only: Does the investigation involve a new use, dosage, schedule, route of administration, or new combination of marketed cancer products in a population with cancer where based on the scientific literature and generally known clinical experience, there is no significant increase in the risk associated with the use of the agent(s)?
Yes* No
* An IND may not be required if this is the only box checked "Yes."
3. Describe the agent(s) to be used in this clinical investigation.
(You may reference the section title and page number(s) of the Investigator Brochure or Package Insert rather than pasting or transcribing the relevant information in the text box. IMPORTANT! Upload the Investigator Brochure or Package Insert to the IRB Application (APP)):
a. Product Description:
b. Clinical Pharmacology:
c. Indications for use:
d. Dosage and Guidelines for Administration: (NA or type here)
e. Dosage and administration in this investigation (if different from approved):
f. Toxicity and Known Side Effects:
g. Precautions and Contraindications:
4. Indicate the phase(s) of the study, if applicable:
a. Phase I
b. Phase II
c. Phase III
d. Phase IV
e. Not Applicable
5. Indicate the Master Protocol / Sponsor Protocol Number, if applicable:
6. Describe how the investigational agent will be prepared, controlled and who will be responsible for management of the agent:
a. N/A: the agent is not investigational
b. UCI Pharmacy
c. The Lead Researcher
i. Describe your plan to ensure that the investigational agent is used only in accordance with the UCI IRB approved protocol:
ii. Describe who will access to the agent and how access will be controlled to secure the drug/biologic:
iii. Specify how records for control of the agent 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):
iv. Specify whether investigational agent is prepared or manufactured in UCI research labs.
Yes (If yes, identify the lab):
No
For information about the use of drugs or biologics in clinical investigations read the UCI IRB webpage at: http://www.research.uci.edu/compliance/human-research-protections/researchers/drugs-biologics-and-devices-clinical-investigations.html.
Also see the 2013 FDA Guidance on Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND @ http://www.fda.gov/downloads/Drugs/Guidances/UCM229175.pdf.
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