Source data verification (SDV) is one of the most expensive, labor-intensive, and error-ridden steps in monitoring clinical trials. During the SDV process, human monitors manually compare information in two or more databases for completeness, consistency, and adherence to the trial protocol. Because SDV is performed manually, it incurs high labor costs and is prone to human-borne errors. Our overall objective with this Phase 1 SBIR grant is to develop a prototype software application that can automate the SDV process. This tool would also incorporate a rules-based engine to compare information in the database to study-specific protocol parameters. Our specific aims are as follows: (1) develop exogenous source data interfaces, (2) develop exogenous configuration data interfaces, (3) design and implement an efficient comparison engine capable of detecting protocol rule violations in the records extracted from multiple exogenous data sources, and (4) perform ?ad hoc ?Study Simulations and Measure the effectiveness of the Swift SDV system.
Public Health Relevance Statement: Project Narrative Source data verification in clinical trials, the manual task of verifying information between a participants health record and a clinical trial database, is a costly and error-prone process. We are proposing a software tool that will automate source data verification by cross referencing information from the two aforementioned sources in a temporary, de-identified database. This tool will allow clinical researchers to quickly identify incongruent data and will improve the speed, cost efficiency, and accuracy of clinical trial monitoring.
NIH Spending Category: Bioengineering; Networking and Information Technology R&D (NITRD)
Project Terms: Adherence; Automation; base; Biotechnology; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Database; Computer software; Conduct Clinical Trials; cost; Cost efficiency; Data; Data Collection; Data Sources; Database Management Systems; Databases; design; Development; Device or Instrument Development; Devices; drug development; effectiveness measure; Electronic Health Record; Employee; Evaluation; Exercise; expectation; Grant; Health; health record; Hospitals; Human; improved; innovation; Knowledge; Manuals; Monitor; Monitoring Clinical Trials; Participant; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Process; Protocols documentation; prototype; Records; Research; Research Personnel; simulation; Site; Small Business Innovation Research Grant; Software Tools; Source; Speed; System; Terminology; Testing; Time; tool; Visit
