A cross-source, system-agnostic solution for clinical data review
| Autor: | Fang Du, Michael A Farnum, Lalit Mohanty, Dimitris K. Agrafiotis, Mathangi Ashok, Victor S. Lobanov, Paul Konstant, Daniel Kowalski, Joseph Ciervo |
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| Rok vydání: | 2019 |
| Předmět: |
Clinical Trials as Topic
0303 health sciences business.industry Computer science Source system 030302 biochemistry & molecular biology Data science Automation Regulatory Submission General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Resource (project management) Databases as Topic Data Warehousing Original Article Statistical analysis User interface General Agricultural and Biological Sciences business 030304 developmental biology Information Systems |
| Zdroj: | Database: The Journal of Biological Databases and Curation |
| ISSN: | 1758-0463 |
| Popis: | Assembly of complete and error-free clinical trial data sets for statistical analysis and regulatory submission requires extensive effort and communication among investigational sites, central laboratories, pharmaceutical sponsors, contract research organizations and other entities. Traditionally, this data is captured, cleaned and reconciled through multiple disjointed systems and processes, which is resource intensive and error prone. Here, we introduce a new system for clinical data review that helps data managers identify missing, erroneous and inconsistent data and manage queries in a unified, system-agnostic and efficient way. Our solution enables timely and integrated access to all study data regardless of source, facilitates the review of validation and discrepancy checks and the management of the resulting queries, tracks the status of page review, verification and locking activities, monitors subject data cleanliness and readiness for database lock and provides extensive configuration options to meet any study’s needs, automation for regular updates and fit-for-purpose user interfaces for global oversight and problem detection. |
| Databáze: | OpenAIRE |
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