Northwell Health

<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 describethe 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 documentsto secure resources and establish procedures.

  • Study Initiation, Conduct and Closure:

The PI and the delegated research staff are responsible for:

  • Notifying the Department of Pharmacy of any changes in study status, which include but not limited to approval, renewal, amendments, completion, closure and termination,
  • 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,
  • 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
  • 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.

The Department of Pharmacy

  • The delegated pharmacist(s)must comply with all applicable federal and state statutes, rules and regulations and Northwell Health 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, Northwell Health 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 facilityto discuss any necessary resources and procedures for each study.
  • The delegated pharmacist(s) will request the following documents and information:
  • Study protocol
  • Investigator’s brochure
  • Pharmacy manual
  • Drug procurement plan and (if the pharmacy department procures the product) reimbursement procedures
  • The delegated pharmacist(s) will assess study feasibility and planfor 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 protocol-specific investigational drug (or pharmacy) binder containing:
  • IRB approval letter
  • Approved protocol
  • Investigator’s brochure
  • Pharmacy manual
  • List of authorized prescribers
  • Randomization charts (if necessary)
  • 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 procurementplan 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.
  • Protocol, sponsor and PI information
  • Subject information (for subject-specific investigational drug supply)
  • Drug name, dosage form and strength
  • Package size and quantity
  • Lot or batch number
  • Kit, bottle or vial numbers
  • Expiration or retest date
  • Temperature during transit
  • 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:
  • Security and safety

<Describe storage conditions and locations for the investigational drugs in your pharmacy, for example,>

Limit access to investigational drugs by authorized personnelonly.

Establish dedicated storage shelf, cabinet, refrigerator and freezer space separate from non-research drugs, other supplies and food.

Label storage compartments with protocol and drug information.

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 labelsfor the same drugs used in multiple protocols.

  • Drug storage temperatures

<Describe how to monitor and record storage temperatures.

<Describe the procedures for any temperature excursionsincluding 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,>
  • Caution: New drug-limited by federal law (or US) to investigational use
  • Study identifier (e.g., protocol number)
  • Prescription or drug order number
  • Subject name
  • Subject address or location in facility
  • Subject study identification number
  • Investigational drug name (or placebo)
  • Investigational drug dosage form and strength
  • Dispensing quantity
  • Administration instructions including dose
  • Directions for storage and other relevant information
  • Preparation or dispensing date and time
  • Expiration date and time
  • Name of prescribing investigator
  • Name of pharmacist
  • Pharmacy name, address and phone numbers
  • 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) willobtain 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) willrecord the final disposition indrug 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:
  • 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.
  • 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:

  • A grant from an FDA official, e.g., electronic communication. The FDA official may authorize shipment and use of the drug by telephone.
  • 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.

  • Protocol or instructions for dose preparation
  • 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 Northwell Health 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 Trials OfficeResearch Billing at <add frequency>.
  • The invoice form can be found at <add share drive location>.

standard statement

REFERENCES

  • NorthwellHealth PolicyGR049:Medications and Investigational New Drugs (IND) used in Clinical Research
  • Northwell HealthPolicyGR050:Use of Controlled Substances in Research

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