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CLOSEOUT LETTER

Advocate Health Care IRB


Advocate Health Care IRB

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
 Food and Drug Administration
Silver Spring, MD 20993

 

Joal M. Hill, JD, MPH, PhD
IRB Chairperson
Advocate Health Care
3075 Highland Parkway
Downers Grove, IL 60515-1288


Dear Dr. Hill:

We refer to the Institutional Review Board (IRB) inspection that Ms. Marcia A. Worley conducted, representing the Food and Drug Administration (FDA), from October 15, 2013 to November 8, 2013 at Advocate Health Care. The purpose of this inspection was to determine whether the IRB was compliant with the regulatory requirements for the protection of human subjects as specified in Title 21 of the Code of Federal Regulations (CFR), parts 50 and 56. These regulations apply to clinical investigations of products regulated by FDA.

During the inspection, Ms. Worley evaluated the IRB’s corrective actions in response to the FDA Warning Letter [Reference #12-HFD-45-05-03] dated June 1, 2012. Based on that evaluation, it appears that the IRB has taken appropriate corrective actions to address the violation contained in the Warning Letter.

This letter does not relieve the IRB from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its associated regulations or with other relevant legal authority. The FDA expects the IRB to maintain compliance with all regulatory requirements. This letter will not preclude any future regulatory action should violations be identified during a subsequent inspection or through other means.

For helpful information on human subject protections, please visit the following FDA web page:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

We appreciate the cooperation shown to FDA Investigator Worley during the inspection. Should you have any questions or concerns regarding this letter or the inspection, please contact me by letter at the address given below.

 

Sincerely yours,

{See appended electronic signature page}

Catherine Parker, RN
Team Lead, Human Subject Protection Branch
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Bldg. 51, Room 5210
10903 New Hampshire Avenue
Silver Spring, MD 20993

 

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This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
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/s/
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CATHERINE E PARKER
04/29/2014