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CDISC - Clinical Data Interchange Standards
Consortium
CDISC is an open, multidisciplinary, non-profit organization committed to the
development of industry standards to support the electronic acquisition,
exchange, submission and archiving of clinical trials data and metadata for
medical and biopharmaceutical product development. The mission of CDISC is to
lead the development of global, vendor-neutral, platform independent standards
to improve data quality and accelerate product development.
FDA Electronic Submissions and Review
The Food and Drug Administration (FDA) regulates
drugs,
biologics and medical
devices. The FDA Center for Drug Evaluation and Research's Electronic
Regulatory Submissions and Review (ERSR) Web page provides information about
the electronic submission of regulatory information to the Center and the
review of it by CDER staff.
QARC - Quality Assurance Review Center
The Quality Assurance Review Center (QARC) is a Global Data and Review Center,
providing Radiotherapy Quality Assurance and Diagnostic Imaging data management
programs for several NCI-supported Cooperative Groups and international
pharmaceutical companies. QARC is a research program within the
University of Massachusetts Medical School. It is an established research resource for
clinical investigators around the world.
RCET - Resource Center for Emerging
Technologies
The Resource Center for Emerging Technologies (RCET) at the University of
Florida (UF) provides advanced technical resources necessary to support
radiotherapy. The use of medical informatics is expected to facilitate
education, collaboration, and peer review, as well as provide an environment in
which clinical investigators can receive, share, and analyze voluminous
multimodality clinical data.
Image Guided Therapy Center at Washington
University
The Image-Guided Therapy Center (ITC) (formerly known as the 3DQA Center) WWW
server at Washington University School of Medicine in St. Louis, Missouri
supports image-based 3D conformal radiotherapy (CRT) multi-institutional
trials.
ACRIN - American College of Radiology Imaging
Network
The American College of Radiology Imaging Network (ACRIN) is a National Cancer
Institute-funded cooperative group. ACRIN's overarching goal is - through
clinical trials of diagnostic imaging and image-guided therapeutic technologies
- to generate information that will lengthen and improve the quality of the
lives of cancer patients.
Medical Image Repository
At the NIH Center for Information Technology (CIT), in collaboration with
NINDS, the
High Performance Computing and Informatics Office (HPCIO) has
developed a Web-based medical image archive system for the archive of imaging
and clinical data from the Suburban Hospital study. This archive system
provides secure Web interfaces for clinical data entry, data upload, database
query, and data download. HPCIO is currently developing a separate archive
system for the GAIN study.
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