CLOSEOUT LETTER

Salem Hospital IRB April 25, 2014

Recipient:: Salem Hospital IRB; United States

Issuing Office:: United States


Department of Health and Human Services	Public Health Service
	Food and Drug Administration Silver Spring, MD 20993

Joseph Schnabel, Pharm.D.
Director of Pharmaceutical Care Services
and IRB Chairman
Salem Hospital Campus
890 Oak Street SE, Building B
Salem, OR 97301

Dear Dr. Schnabel:

We refer to the Institutional Review Board (IRB) inspection that Ms. Gloria Baca conducted, representing the Food and Drug Administration (FDA), from December 11, 2013 to January 7, 2014 at the Salem Hospital. 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. Gloria Baca evaluated the IRB’s corrective actions in response to the FDA Warning Letter, Reference Number 12-HFD-45-11-01 dated November 29, 2012. Based on that evaluation, it appears that the IRB has taken appropriate corrective actions to address the violations 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, Ms. Gloria Baca, during the IRB 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

Cc: Ellen A. Hampton
       Director of Corporate Integrity,
       Safety, and Risk Management
       Salem Hospital
       Salem, OR 97301

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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
04/25/2014

Department of Health and Human Services