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Regulatory and Repository Support
About
What services does this resource provide?
The Regulatory and Repository Support Program provides services to support the work of the Office of Regulatory Affairs (ORA) in the Division of Microbiology and Infectious Diseases (DMID). ORA provides regulatory oversight in the conduct of human subjects research funded by DMID and ensures compliance with federal regulations and policies as well as NIH, NIAID, and DMID policies.
With limited exception, DMID sponsors the Investigational New Drug (IND) and Investigational Device Exception (IDE) for the product being tested in DMID-sponsored clinical trials. ORA serves as the authorized sponsor representative for DMID-held INDs, and IDEs, and as the authorized representative in all communications with the Food and Drug Administration. The Regulatory and Repository Support Program assists with filing INDs and pre-INDs by collecting needed data and documents; providing expert consultation for e.g., auditing, performing technical review of applications and preparing reports.
The Program also maintains a repository of investigational products and biological specimens for use by investigators conducting DMID-sponsored clinical trials. Recipients of investigational products and biological samples must complete requisite GCP training and must follow any and all relevant CFR rules and regulations.
ORA staff work collaboratively with program staff responsible for scientific oversight of the trials and the Office of Clinical Research Affairs, which has responsibility for monitoring the conduct of clinical research.
When needed, all proper agreements are put in place to ensure users proprietary rights, and confidentiality is guaranteed.
Where are the services provided?
Services are provided by
Fisher BioServices
(non-Government link).
Related Resources and Information
Clinical Trials Management and Support
Statistics and Data Coordinating Center for Clinical Research
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Contact Info
Janice Arega
DMID Regulatory Affairs Specialist
E-mail:
aregaj@niaid.nih.gov
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Contact Info
Janice Arega
DMID Regulatory Affairs Specialist
E-mail:
aregaj@niaid.nih.gov
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Last Updated July 14, 2008
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Department of Health and Human Services (HHS)