Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Devices, Inventory Control and Documentation - IRB PRO141

Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Devices, Inventory Control and Documentation - IRB PRO141

Abstract:
This procedure outlines the responsibilities of the investigator, IRB, and OIRB for ensuring handling of investigational or unlicensed test articles meets organizational standards relating to devices, inventory control and documentation.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO141
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets Organizational Standards Relating to Devices, Inventory Control and Documentation

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Submits a copy of the sponsor’s protocol and sponsor-provided device description for all protocols using investigational or commercially available devices or test articles being used in an investigational manner;
  • Designates personnel who may use the device and ensure they have the appropriate training or qualifications to use the device safely;
  • Designates where the study device or test article will be shipped to and stored;
  • Describes the procedures for release of devices (e.g., written physician order) and maintenance of inventory;
  • Provides information on whether the device will be at no cost or billed to the participant or the participant’s insurance;
  • Completes and submits FOR229 Device Review Sheet along with the IRB submission;
  • Maintains records for a period of no less than 2 years after FDA approval or longer, if required by the sponsor, in accordance with FDA regulations.

OIRB Responsibilities

The Senior Staff:

  • Reviews the HSP and verifies it provides a complete description of the procedures related to the use and inventory of the investigational device or test article;
  • Requests additional information, if necessary;
  • Does not issue approval until all required information has been received by the OIRB;

IRB Responsibilities

The IRB:

  • Reviews the HSP to ensure that the investigator or designated personnel are qualified to use investigational devices or test articles; and
  • Determines that storage, control, and dispensing of the investigational device is appropriate so that it only will be used by authorized investigators and on participants.

     


Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director