University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
SOP- Compassionate Use for Devices
Version #: 002
Effective Date: 02/07/11
Supersedes Document: 001
This Policy Pertains to: Compassionate Use
Responsibility for executing this policy: Director, Assistant Director, COMIRB Chairs and Panel
Coordinators
Last Reviewed on: 02/07/11
Result: Approved
Approval Authority: Director
Approved by: Alison Lakin
Date:
02/07/11
1. PURPOSE
To delineate all the steps required for permitting compassionate use of an investigational device.
2. POLICY
The use of an investigational device on a human subject with a serious, albeit not life-threatening
condition in which no standard acceptable alternative treatment is available and which there is not
sufficient time to obtain prospective full IRB review and approval for the use must be reported to
COMIRB.
3. SPECIFIC POLICIES
3.1. Definitions
3.1.1. Investigational device: Industry-sponsored device with an IDE (Investigational Device
Exemption).
3.1.2. Compassionate use: The use of an investigational device in a patient faced with a
serious, albeit not life-threatening condition, for which the investigational device is the
only option available to treat the patient.
3.2. Procedures
3.2.1 Initial Queries
3.2.1.a
All questions for possible compassionate use should be forwarded to the Director or
designated senior staff.
3.2.2 Written Notification
3.2.2.a.
An investigator must submit a report of compassionate use of a device using the
Compassionate Use of Investigational Device Request Form, and all requested
supporting documentation.
3.2.2.b.
Compassionate use reports for adult subjects will be directed to the Adult Panel
Coordinator for review by the appropriate Adult Chair.
3.2.2.c.
Compassionate use reports for pediatric subjects will be directed to the Pediatric
Panel coordinator for review by the appropriate Pediatric Chair.
Compassionate Use SOP
CP-009, Revised 2-7-2011
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University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
3.2.2.d.
Compassionate use reports will be logged in InfoEd and assigned a protocol number
“CU-xxxx,” where “xxxx” is a sequential number beginning with “0001.”
3.2.2.e.
Chair reviews the notification and completes checklist, Form CF-149
3.2.2.f.
These documents submitted for compassionate use are dated and signed by a
COMIRB Chair as “meets criteria for compassionate use”.
3.2.2.g.
A “compassionate use notification letter” CF-149, is generated from the template,
located on the K: drive in the compassionate use folder. The compassionate use
letter is sent out by the panel coordinator.
3.2.2.h.
The compassionate use documents are placed in a brown file folder and filed in the
emergency / compassionate use file drawer.
3.2.3 Safety Monitoring and Reporting
3.2.3.a
The attending physician should devise an appropriate schedule for monitoring the
patient, taking into consideration the investigational nature of the device and the
specific needs of the patient.
3.2.3.b
3.2.3.c
Following the compassionate use of the device, a follow-up report in which summary
information regarding patient outcome is presented should be submitted to COMIRB
within 12 months of the date the compassionate use is reviewed by the chair.
If any problems occurred as a result of device use, these should be reported to
COMIRB within 5 working days of the event or knowledge of the event.
4. RESPONSIBILITY
It is the responsibility of the COMIRB Director, Assistant Director, all COMIRB Chairs and Panel
Coordinators to implement this SOP.
The COMIRB Quality Assurance Coordinator is responsible for review and implementation of the
SOP.
The COMIRB Director and Assistant Director will approve and ensure implementation of this SOP.
5.
APPLICABLE REGULATIONS AND GUIDELINES
FDA Information Sheets “Guidance on IDE Policies and Procedures”1998
6.
ATTACHMENTS
CF-219
Compassionate Use of Investigational Device Request Form
CF-149
Compassionate Use Chair Checklist
CF-218
Compassionate Use Letter Template
Instructions to Clinical Investigators
7. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY
Who
Director
Senior Coordinator
Compassionate Use SOP
CP-009, Revised 2-7-2011
Task
Instruct investigators to submit appropriate Emergency use of Investigational
Drug / Device request form with appropriate supporting documentation as
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University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
outlined.
Chair
Adult Coordinator /
Pediatric Coordinator
Compassionate Use SOP
CP-009, Revised 2-7-2011
Reviews notification and completes checklist
Follow-up per the instructions of the Chair.
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