Download section h - Office of Research Integrity

SECTION I. USE OF DRUGS OR BIOLOGICAL AGENTS
NOTE: If this study involves an FDA regulated drug, please submit any communications from the FDA
regarding IND, or humanitarian use applications related to this submission.
All IRB-approved protocols that involve the administration of FDA-approved medications and/or
investigational medications MUST utilize the NYPH Investigational Pharmacy to dispense the
medications specified in the research protocol. Prior to submission of a new IRB application,
investigators must make arrangements with the Investigational Pharmacy and must have the Use of Drugs
and Biological Agents Form signed by an authorized member of the Department of Pharmacy. This will
ensure that all medications are accounted for and that studies budget properly for the utilization of the
Investigational Pharmacy. Please complete the table below for each medication being administered as
part of the protocol.
Medication Name
Investigational*
Status of Medication:
Off-label Use of FDA- Used According
approved Medication* to FDA Labeling
Service(s) required from the Investigational Pharmacy (select all that apply):
Storage
Inventory/Accountability
Dispensing
Labeling
Re-order medication supplies
Re-pack study medication
Compound study medication
Prepare Intravenous Medications
Perform Randomization
Design Randomization Schema
Prepare Placebo (single or double-blinding)
Patient Drug Returns
Perform Dose Calculations
Prepare Drug Data Sheet
Other special preparation
Will Investigational Pharmacy services be required off-hours and/or on weekends?
Yes
Please submit copies of each of the following materials to the Investigational Pharmacy:
 IRB protocol submission
 Investigator’s brochure/Other sponsor materials related to the protocol
 FDA Form 1572
No
Protocols must be emailed to [email protected]
Please indicate sponsor type:
Industry
Cooperative group
Grant
Investigator initiated with Industry funding
Other, _________________________ (please indicate)
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NCI/NIH/Government funded
Investigator initiated Unfunded
If any medications will be administered and/or dispensed as part of this protocol, please obtain approval from
the Department of Pharmacy. The signature of NYP Pharmacy Management on this document indicates only
the Hospital’s acknowledgement that the Department of Pharmacy will provide facilities, services and other
operational resources in connection with the clinical services required by this study, as per Dr. Forese letter
dated 2/23/2010
______________________________ _________________________________ __________________
Department of Pharmacy
Signature
Date
(Print Name)
Complete the following form for each medication that is investigational or off-label use of an FDA-approved
medication *
Project title
Principal investigator:
Department:
Telephone:
Co-Investigators
(name, degree)
(list only investigators who
are authorized to prescribe
study medication)
Medication Name
(Generic):
Medication Name
(Brand):
Synonyms for Medication:
Manufacturer:
FDA IND#:
Please provide copies of any relevant FDA correspondence related to this IND
Dosage Form:
Strength:
Approval Status of Medication:
Investigational
Off-Label Use of FDA-approved medication
Indication for use in this protocol:
CONROLLED SUBSTANCES: COMPLETE THIS SECTION ONLY IF THE REFERENCED STUDY
UTILIZES SCHEDULE II-V CONTROLLED SUBSTANCES
Schedule of Controlled Substance:
II
III
IV
V
Quantity of the Controlled Substance (The expected amount of drug per patient multiplied by the expected # of
patients to be enrolled: _________________________________________________________________________
When submitting this document to Investigational Pharmacy, please include the following additional documents for
studies utilizing controlled substances:
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

Drug Enforcement Administration Controlled Substance Registration Certificate (Business Activity –
Researcher) of the PI and all Sub Investigators. Please note the certificate must be specific to the
schedule of the relevant controlled substance (II-V)
Drug Enforcement Administration Controlled Substance Registration Certificate of the distributor or
manufacturer providing the substances (note the certificate must be specific to the schedule of the
relevant controlled substance ( II-V)
*At this time the Investigational Pharmacy is not accepting Schedule I Controlled Substances
Note: A copy of this form must be placed in the patient’s medical chart along with a copy of the signed and
dated informed consent.
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