This proposal is in response to PHS 2007-2 NIDA Topic """"""""Automation of the Development of Electronic Data Capture System for Clinical Trials Data Collection and Management"""""""". We propose to develop the Automated Development of Electronic Data Capture (AD-EDC) System, a set of graphical tools and automated software applications that will help simplify, automate, standardize, and reduce the cost of creating and reporting the research instruments used in substance abuse clinical trials. The main objectives of the project are to develop technologies that will: (1) significantly reduce the costs and errors involved in developing electronic data capture (EDC) instruments for clinical trials;(2) significantly reduce the costs and errors involved in reporting and sharing study results;(3) interoperate with a wide-range of information systems and commercial, off-the-shelf clinical trial management systems (CTMS) and utilize Clinical Data Interchange Standards Consortium (CDISC) standards;and (4) provide non-technical, clinical users an easy to use system that includes accessibility support, which will allow users with visual, hearing, physical, and cognitive impairments to effectively participate in clinical trials. The Phase I research effort will focus on defining a high-level architecture for the AD-EDC System, refining functional specifications and user interface designs for the AD-EDC software components, defining an open format for electronic data dictionaries, and performing a cost-benefit analysis to demonstrate that, through software automation and computer-assisted design tools, the project's specific aims are feasible. The Phase II effort will focus on implementing the complete set of study design tools, study reporting tools, and system interoperability components that will be necessary to achieve the project's aims. At the end of Phase II, the AD-EDC System will be pilot tested in a diverse set of real-world clinical settings and a cost-benefit analysis will be performed to validate that the system achieves the project aims.
The AD-EDC System consists of set of graphical tools and automated software modules that will help simplify, automate, standardize, and reduce the cost of creating and reporting clinical research instruments used in substance abuse clinical trials. The AD-EDC System is designed to interoperate with commercial, off-the-shelf clinical trials management systems either through a standard CDISC- compliant ODM interface or through custom external system adapters. Standard data representations based on CDISC standards are used by the tools and components of the AD-EDC System to support interoperability and persistence.
