FDA Science FIRST

FDA Science FIRST is an agency-wide portal which enhances FDA science and helps FDA meet its regulatory obligation under FDAMA by collecting the necessary data and information to protect the public health. The system provides state-of-the-art information technology to optimize knowledge management of scientific resources among the different FDA Centers and to facilitate communication among the scientific community.

One of the major impacts of Science FIRST is to bring together geographically dispersed information sources. Science FIRST serves as a central information source for scientific information that ranges from simple seminar postings to complex FDA Scientific relational databases, commercial CD-ROMs, and Internet scientific sites. Science FIRST was the first intranet-based system at the FDA.

Major components of Science FIRST include the FDA Skills Database, the FDA Research Projects Database, the FDA Publications Database and the FDA CRADA Database.

The FDA Skills Database was developed with agency-wide input to provide a repository that could rapidly identify individuals with a variety of medical, scientific, and technical skill sets. The application provides each member of the FDA staff an individual page where a curriculum vitae or resume can be uploaded and additional information such as languages spoken and equipment expertise can be self-reported. In addition, there are programmatic linkages between Skills and the Research Projects and Publications applications that allow research projects and publications to automatically display on the Skills profile pages of their principal investigators and authors. This linkage in addition to self-reported information by FDA staff provides a powerful insight into the knowledge, skills, and abilities of the FDA workforce.

The success of the broader effort prompted a number of FDA organizations to request customized versions of the Skills database to meet their specific requirements. These include the JIFSAN/CFSAN collaboration effort, the Immunotoxicology, Photosciences Network, and Neurotoxicity working groups, and a registry of individuals possessing foreign language skills of varying levels throughout the Agency.

Possible expansions for this application include listing specific bioterrorism-related skill sets to facilitate the quick mobilization of FDA staff with the appropriate skills in the event of an emergency.

The FDA Research Projects Database was developed to provide an agency-wide repository for research projects from each Center, to allow search and retrieval through an FDA user interface, and database administration through an administrative interface for researchers. The application was developed with flexibility in mind as it allows each Center to capture information specifically relevant to its individual research needs, but display it in a consistent format across all Centers that allows senior leadership to view agency-wide research efforts at a glance. The linkage between the Research Projects and Skills applications allows for those browsing research projects to select a Principal Investigator and, with one click, view the complete profile of that Investigator. This linkage has been so helpful that it is being expanded to include all FDA staff listed in the research project.

The FDA Publications Database provides a single repository for publications written by FDA authors during their tenure with the organization, as well as searching and exporting capabilities for those publications. As part of the Science FIRST program, updates are retrieved from PubMed and the ISI Web of Science.  Additionally FDA staff has the ability to enter publications that have not been captured by the agency-wide import in to the application. A custom search interface was developed that allows browsers of the database to search for publications by a variety of limiters including center, date, author, journal name, and publication title. Some Centers use the output from the Publications database search to construct addendums to their annual reports. Because many of the FDA Publications are developed as the result of a research effort, enhancements to the system will include a linkage between the Publications database and the Research Projects database to allow for a cross-reference between the research project and the product of that work.

The FDA Cooperative Research and Development Agreements (CRADA) database is a centralized repository that was developed to provide oversight into the management of FDA CRADAs. A CRADA is an agreement between one or more FDA laboratories and one or more non-Federal parties, under which the FDA provides personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts. The application allows FDA senior leadership to efficiently manage CRADA relationships by displaying relevant information about proposed CRADAs, Partner organizations, FDA Principal Investigators and Center Liaisons. The application shows the status and the actions required for a given CRADA to obtain approval. A custom search and reporting feature was implemented that graphically displays CRADAs by FDA Center, CRADAs by Fiscal Year, and CRADA status. The CRADA database significantly streamlines the FDA governing process to manage CRADA relationships and has been an invaluable tool for FDA senior leadership.

Science FIRST uses a number of different technologies including Java 2 Enterprise Edition (J2EE), Oracle RDBMS, Oracle 10g Application Server, Adobe ColdFusion 7.0, and Citrix Presentation Server 4.0.