Expanded Access to Investigational Drug, Biologic or Device for Individual or Small Group Treatment

Complete this form when you seek MCRF IRB approval to treat patient(s) by using an unapproved investigational test article (drug, device or biologic) for non-emergency but severely debilitating or life-threatening conditions where no other available treatments are satisfactory and use would be outside of a research protocol.

Complete this form when you seek MCRF IRB approval to treat patient(s) by using an unapproved investigational test article for non-emergency but severely debilitating or life-threatening conditions when no other available treatments are satisfactory and use would be outside of a research protocol. This form must be completed and submitted to the Office of Research Integrity & Protections (ORIP) – 1R4 prior to the use.

SP Code:

Title:

Principal Investigator:

Date:

Routing Location:	Phone:

Location of Expanded Access:

Check all that apply:

Marshfield Clinic Site(s)

Ministry Health Care Site(s) (includes St. Joseph's Hospital; St. Clare's Hospital; & St.

Michael's Hospital)

Sacred Heart Hospital, Eau Claire (Oncology only)

Multiple Sites, including at least one site external to MC or MHC (list the sites below)

Description of Planned Expanded Access:

Access requested for an investigational:

Drug

Device

Biologic

Select which of the following scenarios best describes this request to use the unapproved test article:

Treatment for an individual patient who is not eligible for any clinical trial of the test article.

Use for an intermediate patient population under a treatment IND or IDE.

Use for a patient or multiple patients on an open treatment protocol where continued access

INDs and IDES are in place after a controlled trial has ended, but treatment is continued so

that participants may continue to benefit from the test article until marketing approval is

obtained.

Describe the condition of the patient(s):

Explain the circumstances necessitating treatment, and confirm that there are no other viable treatments available:

Has a sponsor approved the proposed use?

No

Yes - attach proof of approval:

Explain (or attach separately) the treatment plan or protocol, including a description of all patient protection measures that will be followed:

Attach a copy of the informed consent document.

STATEMENT

“I certify that the information provided is accurate and complete to the best of my knowledge.

___________________________________

Signature of Treating Physician	Date

Printed Name of Treating Physician	Routing Location

Printed Name of Person Completing Submission	Routing Location

Jaros, Linda M.

2014-08-04

Hubing, Melissa E.

Marshfield Clinic