Protocol-Specific Guidelines Formanagement of Investigational Product(S)

Protocol-Specific Guidelines Formanagement of Investigational Product(S)

  • 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 availablein documents, please contacta relevant sponsor or monitor to obtain specific information.
  • Please modify the template as applicable to each study.

Protocol-specific Guidelines forManagement of Investigational Product(s)

IRB Number
Sponsor Protocol Number
Protocol Title
Investigational Product(s) / Enter Name
Enter Dosage form, strength, package size
Principal Investigator (PI) / Name
Email
TEL / FAX
Study Coordinator / Name
Email
TEL / 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.

Patient Enrollment and Request for Investigational Product(s)

  • The PI or designee will contact a designated pharmacist regarding patient enrollment and/or treatment and provide:
  • A copy of signed informed consent
  • Drug order and/or prescription
  • Arm and dose assignment
  • Medication identification numbers assigned
  • Other relevant information at least 3 to 5 days prior to the actual treatment date OR at their earliest availability.
  • 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

  • Please specify:
  • Staffresponsible for ordering product(s)
  • Product order form
  • Supplier contact information
  • Minimum and maximum quantity on stock
  • Time restraint
  • Telephone or web-based ordering system
  • Other relevant information
  • In addition, please describe procedures for the productreceipt, for example,
  • Shipping documents to file
  • Communicatingthe confirmation of the receipt with the sponsor
  • Disposition of temperature recordingdevice in packages

Accountability

  • Please indicate:
  • Specific accountability forms
  • Frequency of verifying accountability record with actual inventory
  • Other relevant information

Product Storage

  • Please specify:
  • Storage location(s) of the investigational product(s)
  • Storage requirementsincludingsecurity and temperature (e.g., room temperature, refrigerator,and freezer)
  • Temperature monitoringmethods
  • Procedures for temperature excursion as instructed by the sponsor

Dose Schedule

  • Please describe:
  • Dose schedule
  • Dose assignment
  • Dose calculation
  • Criteria for dose escalation or reduction

Dose Preparation

  • Please providespecific 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 preparedinvestigational product
  • Other requirements

Dose Administration

Please describe directions for administration and any special instructions to provide subjects or health professionals.

Labeling

Please show an example ofyour label for the study.

  • 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

ProductPick-up and Delivery

Please describe your procedures for product pick-up and delivery (e.g., inpatient, dispensation by mail).

ProductReturn

Please describe the procedure for product(s) returned from patient and/or study coordinators. It is recommended to use a form for records.

ProductDisposition

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 Northwell Health 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

FAX cover sheet

The research team may want to use this sheet when requestinginvestigational product(s) by fax.

FAX COVER

TO / Northwell Health Pharmacy Name
Fax #
FROM / PI Name
Research Coordinator’s Name
TEL#
Pager#
IRB# or protocol#
Subject Name
Subject Study ID
Height/Weight/BSA(if applicable)
Patient Location (if applicable)
Drug Name
Arm/Dose (if applicable)
Assigned med ID # (if applicable)
Drug(s) needed by (Date and Time)

Please send the request 3 to 5 days in advance if possible. Thank you.

Confidentiality Notice:
This fax and any attachments may be confidential and protected by legal privilege. If you are not the intended recipient, be aware that any disclosure, copying, distribution or use of the fax or any attachment is prohibited. If you have received this fax in error, please notify us immediately by contacting the sender and then shred the documents. Thank you for your cooperation.

Prescription or order example

Please provide an example of inpatient or outpatient prescription or order as applicable to the study.

  • IRB/Protocol #
  • 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
  • Assigned medication numbers
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