Developing Treatment, Treatment Validation, and Treatment Scope in the Setting of an Autism Clinical Trial

Abstract

The first year of the project has been used to obtain IRB approval from the UMDNJ-RWJMS IRB office. We obtained IRB approval on December 7th, 2009. Our approved protocol and supporting documents have been submitted to the Human Research Protection Office (HRPO) Office of Research Protections (ORP) of the DOD for review. We are also in the process of applying for a Certificate of Confidentiality from the NIH as per our IRB requirements. No Human Subjects Work will be done until we receive either a COC or a letter indicating we do not need one. Once we have approval from the Human Research Protection Office (HRPO) Office of Research Protections (ORP) of the DOD we will continue work on Tasks 2 -3. Work on Tasks 4 - 5 will not begin until subject recruitment and treatment has occurred.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2009
Accession Number
ADA517259

Entities

People

  • T. P. Stein

Organizations

  • University of Medicine and Dentistry of New Jersey

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  • Biomedical

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  • Biological Products
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