Developing Treatment, Treatment Validation, and Treatment Scope in the Setting of an Autism Clinical Trial
Abstract
The second 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 were submitted to the Human Research Protection Office (HRPO) Office of Research Protections (ORP) of the DOD for review. We applied for and received a Certificate of Confidentiality from the NIH as per our IRB requirements. The test material DHA and the placebo were acquired from Martek with a significant and unforeseen delay. (Please see Task #2 in this Document). Subject recruitment has been organized. A Continuing Review has been applied for. The Data Safety Monitoring Board (DSMB) has been set up and provided with necessary documents to hold their initial meeting with the exception of the CR which will be sent as soon as we receive. Human Subjects recruitment and tasks #3 through 7 will begin once the DSMB have given approval. We are in the process of arranging additional sources of ADOS and ADI tested subjects so that we can reach our recruitment goals more quickly. In addition, as originally designed samples from AGRE would be obtained by initiating project W81XWH-08-1-0728 for the relevant tasks of project W81XWH-08-1-0728. To simplify matters since the IRB approval is in Dr. Novotny's name this task was moved to this project (W81XWH-08-1-0730). We submitted a material transfer agreement and a formal application including the changes in the research design made in the last two quarters (detailed in initiating project W81XWH-08-1-0728 under Task 4) to AGRE. The application has been approved.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2010
- Accession Number
- ADA540356
Entities
People
- Sherie Novotny
Organizations
- Robert Wood Johnson Medical School