Procedures to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Pharmacy, Inventory Control, and Documentation - IRB PRO121

Abstract:
This procedure lists the responsibilities of the investigator, IRB, OIRB, and Pharmacy to ensure handling of investigational or unlicensed test articles meets organization standards relating to pharmacy, inventory control, and documentation.
Effective Date:
2/16/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO121
Effective Date:   3/30/07
Revision Date:  2/16/10
Subject:  Procedures to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Pharmacy, Inventory Control, and Documentation

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Submits to the pharmacy for all protocols using investigational or commercially available drugs:
    • A copy of the sponsor’s protocol;
    • Investigator’s Brochure for IND studies; and
    • A completed and signed FOR217 (UAB) or FOR218 (TCHA) Release of Drugs for Human Research Use form, as applicable.
  • Designates personnel who may administer the medication and ensures they have the appropriate training to administer the medication safely;
  • Designates where the study drug or test article will be shipped and stored;
  • Describes the dispensing procedures (i.e., written physician order or prescription) ;
  • Indicates the mechanism by which the pharmacy will be reimbursed for services;
  • Submits the executed Release of Drugs for Human Research Use form together with the IRB submission;
  • Completes and submits FOR230 Drug Review Sheet with the IRB submission;

Pharmacy Responsibilities

The Pharmacy:

  • Reviews the investigator’s protocol and the Release of Drugs for Human Research Use form and evaluates whether the investigator’s plan for the storage, control, and dispensing of each investigational drug is adequate to ensure that only authorized investigators will use the drug and they will use the drug only in participants who have provided consent and only in accordance with applicable UAB/TCHA Hospital standards (see SUP406 Research Study/Investigational Medications, Patient Participation in; SUP407 Patient Participation in Research, Investigation, or Clinical Trials; SUP408 Investigational Drugs, Handling and Dispensing; SUP409 General Clinical Research Center Outpatient Clinic Medication Orders);
  • Calculates the fee per dose or course for the investigational drug or test article to be charged to the patient, grant, or other source;
  • Assists the investigator in the proper storage and distribution of the drug;
  • Signs the approved Release of Drugs for Human Research Use form and returns it to the investigator;
  • Refers to the Investigational Drug formulary to provide a central agency in the hospital for information on and supply of investigational drugs;
  • Prepares and labels drug or test article being dispensed;
  • Records an entry of all doses received, dispensed, unused, returned and destroyed in the Investigational Drug Inventory/Dispensing Log;
  • Performs inventory checks on stock at regular intervals;
  • Maintains records for a period of no less than two years after FDA approval/IND termination or longer, if required by the sponsor, in accordance with 21 CFR 312.62;

OIRB Responsibilities

The Senior Staff:

  • Reviews and verifies the Release of Drugs for Human Research Use form is completed and signed by both the investigator and the Director of the Pharmacy;
  • Does not issue approval until the Release of Drugs for Human Research Use form signed and approved by pharmacy and received by the OIRB.

The IRB:

  • Reviews the HSP to ensure that the investigator or designated personnel are qualified to dispense and/or administer investigational drugs.

Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director