The long-term objective of the project is to design and develop a multi-component database system in order to store and analyze information related to the Human Subjects Protection Program (HSPP). This goal is accomplished through the formation of a project management team to analyze the needs of the HSPP, build a data warehouse system that will house current data, and historical data and text, create interactive domains for internal and external users through a web based portal, provide adequate security for web-based interaction as well as for the relational database and construct ongoing reports for informational needs as well as administrative use. The three specific aims are: 1) Identify and define database needs for Human Subjects Protection Program (HSPP) through interview, questionnaire, observation, documentation and notation in order to upgrade existing computer programs and allow an interface between the existing database and new program components, 2) Develop new program components including: education and training, financial conflict of interest, and adverse events, and 3) Design and create security measures to allow protection of data systems including a secure user entry subsystem and a back-up system. The project will be conducted in five phases in order to meet the specific aims: Analysis - Creation of formal documents and notation in order to select the essential features of the proposed system. Communication - Formation of team meetings held between project team members and staff in order to communicate initial project analysis, project updates and finalization of plans for implementing selected features of the database Construction - The construction phase of the project. This phase will also include designing the process for importing data from the current database into the newly constructed database. Training - Instruction for staff with regards to data entry into the new system as well as report generation. Evaluation - Assessment of recommendations from project team members, staff and research personnel in order to assess any needed changes and accessibility and timeliness of reports.
