The Department of Pharmacy, Enter the name of hospital or medical center
The North Shore-LIJ Health System
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Please use this template as applicable 1) to establish dispensing procedures with a research team and 2) to train backup pharmacy staff.
Please refer to a study protocol and other relevant documents for study-specific information. If information is not available in
documents, please contact a relevant sponsor or monitor to obtain specific information.
Please modify the template as applicable to each study.
Study-specific Guidelines for Management of Investigational Product(s)
IRB Number
Sponsor Study Number
Protocol Title
Enter Name
Enter Dosage form, strength, package size
Investigational Product(s)
Principal Investigator (PI)
Study Coordinator
Pharmacist
Name
Email
TEL
Name
Email
TEL
Name
Email
TEL
FAX
FAX
FAX
Study Background
Please provide a brief summary of disease or condition and background on investigational product(s).
The Purpose of the Study
Please provide the main objective of the study.
Study Design
Please describe phase, blinding, arms, randomization, size of enrollment, study duration and other
relevant information.
PI’s Responsibilities
o
PI assumes responsibility to provide:
 An IRB approval letter, an approved protocol, FDA form 1572 or delegation of
responsibilities, investigator’s brochure and pharmacy manual, if available, prior to the
initiation of a study and
 IRB renewal letters, updated protocol versions, amendments and the updated list of
authorized prescribers throughout the conduct of the study to relevant NSLIJ Health
System pharmacy staff.
o
In addition, the PI is responsible to notify relevant NSLIJ Health System pharmacy staff of study
status, patient status and any relevant communications from the sponsor.
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The Department of Pharmacy, Enter the name of hospital or medical center
The North Shore-LIJ Health System
Patient Enrollment and Request for Investigational Product(s)
o
The PI or designee will contact a designated pharmacist regarding patient enrollment and/or
treatment and provide:
 Completed informed consent,
 Drug order and/or prescription (NYS official prescription for outpatient medications, NSLIJ
health system electronic or paper order for inpatient or outpatient medications in
compliance with relevant laws, regulations and the NSLIJ Health System policies),
 Arm and dose assignment,
 Randomization and
 Other relevant information at least 3 to 5 days prior to the actual treatment date OR at
their earliest availability.
o
The PI or designee may fax documents to the pharmacy to facilitate drug preparation and
dispensation and bring original prescription or order, if applicable, in exchange of the
investigational product(s).
Product Procurement
o
Please specify:
 Staff responsible for ordering product(s),
 Product order form,
 Supplier contact information,
 Minimum and maximum quantity on stock,
 Time restraint and
 Other relevant information.
o
In addition, please describe procedures for the product receipt, for example,
 Shipping documents to file,
 Communicating the confirmation of the receipt with the sponsor and
 Disposition of temperature recording device in packages.
Accountability
o Please indicate:
 Specific accountability forms,
 Frequency of verifying accountability record with actual inventory and
 Other relevant information.
Product Storage
o Please specify:
 Storage location(s) of the investigational product(s),
 Storage requirements including security and temperature (e.g., room temperature,
refrigerator, and freezer),
 Temperature monitoring methods and
 Procedures for temperature excursion as instructed by the sponsor and the Health System.
2
The Department of Pharmacy, Enter the name of hospital or medical center
The North Shore-LIJ Health System
Dose Schedule
o Please describe:
 Dose schedule,
 Dose assignment,
 Dose calculation and
 Criteria for dose escalation or reduction.
Dose Preparation
o Please provide specific instructions for drug preparation.
 Randomization
 Specific forms and/or product original label to be filed
 Packaging requirements for oral solid medications and other dosage forms (e.g., policy on
bottle opening, specific requirements on immediate container)
 Compounding for oral liquid, sterile IV products (e.g., reconstitution, diluents, specific
requirements for IV bag, bottle and administration set, final concentration or volume, light
sensitivity, filtration, stability) and other dosage forms
 Expiration date and/or time of the investigational product
 Other requirements and cautions
Dose Administration
Please describe directions for administration and any special instructions.
Labeling
Please show an example of your label for the study.
o The label shall bear
 Caution: New drug-Limited by federal law (or US) to investigational use
 Study identifier (e.g., IRB number)
 Prescription or drug order number
 Subject name
 Subject address or location in hospital or center
 Subject study identification number
 Investigational product name (or placebo)
 Investigational product dosage form and strength
 Dispensing quantity
 Administration instructions including dose
 Directions for storage and other relevant information (e.g., controlled substances,
refrigeration, drug and/or food interactions)
 Preparation or dispensing date and/or time
 Expiration date and/or time
 Name of prescribing investigator
 Name of dispensing pharmacist
 Dispensing pharmacy name, address and phone number
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The Department of Pharmacy, Enter the name of hospital or medical center
The North Shore-LIJ Health System
Product Pick-up and Delivery
Please describe your procedures for product pick-up and delivery (e.g., inpatient, dispensation by mail).
Product Return
Please describe the procedure for product(s) returned from patient and/or study coordinators. It is
recommended to use a form for records.
Product Disposition
Please describe the sponsor’s policy and procedures regarding return and/or disposal of used, unused
and/or expired product(s). If sponsor approves disposal on site, please specify the method of disposal in
compliance with the sponsor’s instruction and the NSLIJ Health System policies and procedures.
Backup Pharmacist(s)
Please list other pharmacy staff responsible for the study.
Written by:
Date:
Pharmacist’s name
Reviewed by:
Date:
Supervisor’s name
Approved by:
Date:
PI’s name
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The Department of Pharmacy, Enter the name of hospital or medical center
The North Shore-LIJ Health System
FAX cover sheet
The research team may want to use this sheet when requesting investigational product(s) by fax.
FAX COVER
TO
FROM
NSLIJ HS Pharmacy Name
Fax #
PI Name
Research Coordinator’s Name
TEL#
Pager#
IRB#
Patient Name
Patient Study ID
Height/Weight/BSA (if applicable)
Patient Location (if applicable)
Drug Name
Arm/Dose (if applicable)
Randomization # (if applicable)
Drug(s) needed by (Date and Time)
Please send the request 3 to 5 days in advance if possible. Thank you.
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The Department of Pharmacy, Enter the name of hospital or medical center
The North Shore-LIJ Health System
Prescription or order example
Please provide an example of inpatient or outpatient prescription or order as applicable to the study.
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IRB #
Authorized prescriber name, contact information and signature
NPI and/or DEA registration number
Date
Patient name
Patient date of birth
Patient study ID#
Patient relevant profile
Drug name
Dosage form and strength
Quantity
Drug dose
Dose duration and/or frequency
Specific administration dates
IV diluents
Total volume and/or final concentration
Infusion rate, volume and/or duration
Route of administration
Directions
Special instructions
Randomization number
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