FDA NCTR Research Support
Investment ID: 009-000005332
Overview
Program Title
FDA NCTR Research Support
Description
RSS, through its component modules, collects subject and experiment data from the introduction of an animal into the NCTR environment by purchase or birth through the experiment process and concludes with the data collected from pathological examination of its tissues. Individuals participating in the conduct of research at NCTR have access to this system (this includes research scientists, support scientists and technicians who are key stakeholders in addition to the Center Director and Office of Research). RSS is integral to NCTR s ability to conduct research in support of FDA s science-based, regulatory mission. The investment is comprised of one system with multiple modules. The majority of the modules are applications developed and maintained at NCTR by Government FTE's. While there are commercial products integrated into the workflow, there are no software development contracts.
Type of Program
Non-major IT Investments
Multi-Agency Category
Not Applicable
Investment Detail
RSS contains a number of modules that have been customized and adapted over many years to support the multigeneration toxicology research at NCTR. The tools have been developed by staff at NCTR and as such are easily customized to meet the evolving needs of new research paradigms. The investment supports the collection, storage and aggregation of data from diverse research protocols including pathology, bioimaging, bioinformatics, behavioral testing, and in-life non-clinical studies. This investment directly supports the ability of NCTR scientists to perform regulatory research which in turn supports FDA's ability to make science based decisions. Without the data collection services provided in RSS, NCTR would require a significant increase in the number of support staff (including contractors) to collect data, make on-the-fly calculations and adjustments within the animal data collection rooms. This would increase the possibility of errors and place the integrity of the research at risk. Commercial products have been considered to replace some modules of RSS where it makes sense to do so. Historically, research at NCTR has required flexibility and customization that would make COTS products less desirable and less cost effective. There are no legislative mandates, audit findings or Presidential Directives affecting RSS..