North Shore – LIJ Health System, Inc.
<Enter name of your pharmacy department>
SOP TITLE: INVESTIGATIONAL DRUG SERVICE (IN THE DEPARTMENT OF PHARMACY)
SOP # and version:
Prepared by: <Insert Name and Title>
Approved by: <Insert Name and Title>
Approval Date:
 OBJECTIVE:
The objective of this Standard Operating Procedure (SOP) is to describe the investigational drug service
in the Department of Pharmacy.
 RESPONSIBILITIES:
The Principal Investigator (PI) and the Delegated Research Staff

Study Feasibility:
The PI and the delegated research staff are responsible for notifying the Department of Pharmacy of
any potential studies and for providing any necessary documents to secure resources and establish
procedures.

Study Initiation, Conduct and Closure:
The PI and the delegated research staff are responsible for:
o Notifying the Department of Pharmacy of any changes in study status, which include but not
limited to approval, renewal, amendments, completion, closure and termination,
o Providing 1) IRB approval and renewal letters, 2) initial and updated lists of authorized
prescribers, 3) essential documents and their updated versions and 4) any pertinent
communications from the sponsors throughout the study,
o Notifying the pharmacist(s) of upcoming dosing schedules using <describe communication
method, e.g., Outlook calendar, daily or weekly list> and any changes in subject status AND
o Providing the following documents for dose preparations in advance, if possible.
 The first and signature page of the signed informed consent form for each subject PRIOR to
the first dispensation.
 Prescriptions and drug orders signed ONLY by the authorized prescribers for each study.
 Any protocol-specific documents for each dispensation (e.g., randomization to treatment arm,
dose assignment, assigned kit, bottle or vial numbers and subject weight or BSA) upon
availability.
<Approval date>
<SOP #>
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North Shore – LIJ Health System, Inc.
<Enter name of your pharmacy department>
The Department of Pharmacy

The delegated pharmacist(s) must comply with all applicable federal and state statutes, rules and
regulations and Health System policies on the management of investigational drugs (including
procurement, storage, preparation, dispensation, disposal, accountability, documentation and
reporting and record keeping requirements).

The delegated pharmacist(s) must complete any trainings required by the sponsors, the Health
System and other applicable organizations.
 PROCEDURES:
Study Feasibility

The PI and delegated staff will contact <Enter name and title of the main research pharmacist and/or
the pharmacy leadership at each facility> to discuss any necessary resources and procedures for each
study.

The delegated pharmacist(s) will request the following documents and information:
o Study protocol
o Investigator’s brochure
o Pharmacy manual
o Drug procurement plan and (if the pharmacy department procures the product) reimbursement
procedures

The delegated pharmacist(s) will assess study feasibility and plan for procurement, storage,
preparation, dispensation, disposal, accountability and documentation of the investigational drug.

If necessary, secure any equipment and ancillary supplies.

If necessary, establish a contract with the PI.

The delegated pharmacist(s) may need to meet with potential sponsors during site-selection visits.
They should prepare answers to frequently-asked-questions (or present this SOP).
Study Initiation

Upon the notification of the IRB approval, the delegated pharmacist(s) will establish a protocolspecific investigational drug (or pharmacy) binder containing:
o IRB approval letter
o Approved protocol
o Investigator’s brochure
o Pharmacy manual
o List of authorized prescribers
o Randomization charts (if necessary)
<Approval date>
<SOP #>
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North Shore – LIJ Health System, Inc.
<Enter name of your pharmacy department>
o
Any protocol-specific forms (e.g., investigational drug order form, drug accountability record
form)

The delegated pharmacist(s) may need to meet with the sponsors during site-initiation visits. They
should prepare a list of any pertinent questions.

The delegated pharmacist(s) will complete any required trainings and procedures (e.g., IVRS/IWRS,
dose preparations) and retain documentation.

The delegated pharmacist(s) will discuss the drug procurement plan with the research team.
Drug Procurement

The delegated pharmacist(s) will order investigational drugs according to the sponsor’s instructions.

The delegated pharmacist(s) will retain both blank and completed drug order forms for their records.
Receipt of Drug

Upon receipt of a drug package, the delegated pharmacist(s) will verify the following information in
the shipping document and confirm the receipt as instructed by the sponsor.
o Protocol, sponsor and PI information
o Subject information (for subject-specific investigational drug supply)
o Drug name, dosage form and strength
o Package size and quantity
o Lot or batch number
o Kit, bottle or vial numbers
o Expiration or retest date
o Temperature during transit
o Damage and discrepancy

The delegated pharmacist(s) will retain the shipping documents and delivery/receipt confirmation in
the investigational drug binder.
Drug Storage

The delegated pharmacist(s) will ensure the following storage conditions:
o Security and safety
<Describe storage conditions and locations for the investigational drugs in your pharmacy, for
example,>
 Limit access to investigational drugs by authorized personnel only.
 Establish dedicated storage shelf, cabinet, refrigerator and freezer space separate from nonresearch drugs, other supplies and food.
 Label storage compartments with protocol and drug information.
<Approval date>
<SOP #>
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North Shore – LIJ Health System, Inc.
<Enter name of your pharmacy department>
 Store each drug, each dosage form and each drug strength under the same study in separate
compartments.
 Separate used, returned and expired drugs from the working stock.
 Establish safeguards such as caution labels for the same drugs used in multiple protocols.
o Drug storage temperatures
 <Describe how to monitor and record storage temperatures.>
 <Describe the procedures for any temperature excursions including back-up storage areas,
documentation and reporting requirements.>
 <Describe any plans for emergency situations.>
Drug Preparation and Dispensation

The delegated pharmacist(s) will verify information in the documents provided by the research team
against each protocol, signed informed consent form (the 1st dispensation only) and list of authorized
prescribers. Clarify any questions with the research team in writing. Errors need to be corrected
PRIOR to dose preparation.

The delegated pharmacist(s) will complete and retain any protocol-specific documents for each
preparation and dispensation.

The delegated pharmacist(s) will follow protocol-specific instructions, site policies, procedures and
any applicable regulations for preparation (including compounding and repackaging) and
dispensation.

Drug label should retain the following information: <Provide the label contents, for example,>
o Caution: New drug-limited by federal law (or US) to investigational use
o Study identifier (e.g., protocol number)
o Prescription or drug order number
o Subject name
o Subject address or location in facility
o Subject study identification number
o Investigational drug name (or placebo)
o Investigational drug dosage form and strength
o Dispensing quantity
o Administration instructions including dose
o Directions for storage and other relevant information
o Preparation or dispensing date and time
o Expiration date and time
o Name of prescribing investigator
o Name of pharmacist
o Pharmacy name, address and phone numbers
<Approval date>
<SOP #>
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North Shore – LIJ Health System, Inc.
<Enter name of your pharmacy department>

Drug pick-up and delivery
<Describe whether the research team will pick up or the Department of Pharmacy will deliver the
prepared drugs.>
Drug Disposal

The delegated pharmacist(s) will obtain and retain written procedures and approval for used, unused
and expired investigational drugs PRIOR to their return to the sponsor or on-site disposal.

<Describe on-site disposal procedures including waste bins, service department and vendors.>

The delegated pharmacist(s) will record the final disposition in drug accountability records and retain
any other disposal records.
Drug Accountability

The delegated pharmacist(s) will record every drug transaction, including but not limited to, the
receipt, preparation, dispensation, transfer, distribution, disposal, scheduled inventory verification, in
a protocol-specific drug accountability record form. Complete all information as required in each
drug accountability record form.

The delegated pharmacist(s) will use separate drug accountability record sheet for each protocol,
each drug, each dosage form, each drug strength, each lot number and each storage location.

The delegated pharmacist(s) will schedule periodic inventory verification <add frequency> to
reconcile any discrepancies, secure sufficient supplies for upcoming subject visits and dispose of any
expired drugs.
Special Situations
<Add any other special situations.>
 Dispensing investigational drugs from automated dispensing machine (e.g., Pyxis)
<Describe the procedures.>

Mailing or transporting investigational drugs
<Describe the procedures.>

Re-labeling investigational products upon request from the sponsors
<Describe the procedures.>

Subjects participating in clinical research at another institution:
o The admitting physician or the investigator is responsible for notifying the Department of
Pharmacy immediately, obtaining the protocol, IRB approval, signed consent form and other
relevant documents from another institution and providing their copies to the Department of
Pharmacy.
<Approval date>
<SOP #>
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North Shore – LIJ Health System, Inc.
<Enter name of your pharmacy department>
o The Department of Pharmacy will be responsible for the management of the investigational drug
pursuant to the physician's order and protocol.

Procedure for individual patients in emergency settings (Expanded access emergency use; also
known as compassionate use)
The investigator will provide the following documents:
o A grant from an FDA official, e.g., electronic communication. The FDA official may authorize
shipment and use of the drug by telephone.
o A signed informed consent form from the subject or legally authorized representative unless both
the investigator and a physician not participating in the treatment use certify in writing that:
 The subject is confronted by a life-threatening situation where the use of the drug is
necessary and there is no alternative therapy to save the life of the subject; AND
 Informed consent cannot be obtained from the subject or the subject’s legal representative.
o Protocol or instructions for dose preparation
o Prescription or drug order
NOTE: Emergency use is an EXEMPTION from prior review and approval by the IRB.
Controlled Substances

The Department of Pharmacy will follow the Health System Policy GR050 Use of Controlled
Substances in Research, other institutional policies and applicable regulations.

<Describe storage conditions and location, procedures for the management of controlled substances
and delegated pharmacy staff.>
Off-hour Service
<List back-up pharmacists and describe procedures for off-hour investigational drug service.>
Reimbursement for Investigational Drug Service

The delegated pharmacist(s) will send invoices for investigational drug service to the Clinical
Research Service Finance Core at CRSBilling@nshs.edu <add frequency>.

The invoice form can be found at <add shared drive location>.
 REFERENCES
 NSLIJHS Policy GR049: Medications and Investigational New Drugs (IND) used in Clinical
Research
 NSLIJHS Policy GR050: Use of Controlled Substances in Research
<Approval date>
<SOP #>
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