Protocol Name:
Principal Investigator:
Primary Contact Name: / Contact Info:
Date:
Study Numbers (IF, HS, GCO):
Appendix B: Drugs+/Biological Products++
(Make or download additional copies of this page as needed)
(Complete this form for all drugs+ and biological products++ whose use is specifically prescribed in the research. This form does not need to be completed for approved drugs whose use is totally up to the discretion of an attending physician as part of medical care. Contact the PPHS if unsure.)
SECTION 1
Does the protocol include drugs and/or biologics as routine care, and these are supplied through the hospital pharmacy or U.S. commercial pharmacy supply?
No Yes
SECTION 2
List all drugs and biologics being used in the research not as routine care.
This includes approved drugs that are supplied or paid for by the company for this research, approved drugs that are not given under routine care guidelines, and all investigational drugs:
Generic / Brand Name / IND # (or None) / Name of IND holder
For each drug/biologic with an IND number, ensure that the application includes one of the following:
· Sponsor protocol with the IND number ·Communication from the sponsor or the FDA with the IND number
To receive IRB approval you must obtain the following the signature below to indicate that Investigational Drug Service of the Hospital Pharmacy has reviewed and approved the control of drugs and biologics in this study. Changes made to the approved plan for control of drugs and biologics require a new IDS approval.
______
SIGNATURE, IDS PHARMACY REPRESENTATIVE Date
Drug/Biologic Control Provided Under: (Pharmacy Initials)
______Research Pharmacy Plan: ______
PRINTED NAME OF IDS PHARMACY REPRESENTATIVE Investigator (or 3rd party) Plan: ______
Hospital Pharmacy Plan: ____
+Dietary supplements, nutraceuticals, and other compounds, when intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (including studies for that purpose) are considered drugs. Drugs also include “articles (other than food) intended to affect the structure or any function of the body of man or other animals” including endogenous compounds used to provoke or blunt a physiologic response.
++ Live organisms may be both a biological product and a drug.
Please see the PPHS and other institutional websites for further guidance about drugs and biological products, Investigational New Drug regulations, and the responsibilities of investigators who become IND sponsor-investigators.
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Revised 10/18/12