How to satisfy regulatory concerns about EDC data integrity and site controls over its source records.
Dean A. Gittleman
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Articles by Dean A. Gittleman
Study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry.
The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality.
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Latest Updated Articles
Risk-Based ApproachesPublished: August 1st 2013 | Updated:
Three-Pronged Approach to Optimizing Trial MonitoringPublished: June 1st 2014 | Updated:
eSource Records in Clinical ResearchPublished: April 16th 2015 | Updated:
- eSource Records in Clinical Research: Keeping it Simple
Published: August 1st 2015 | Updated:
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