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# FDA Promotes Centralized Statistical Trial Monitoring
- URL: https://www.fdaweb.com/fda-promotes-centralized-statistical-trial-monitoring/
- Published: 2024-12-13T12:00:00.000Z
- Updated: 2026-09-14T14:49:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158365

FDA is encouraging drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues. Such monitoring has become “increasingly feasible with the advent of computerized systems and the increasing use of electronic records which facilitate remote access to electronic data…,”said CDER Division of Analytics and Informatics deputy director **Paul Schuette** during a 12/3-posted podcast. He also said that statistical assessments using data captured with paper case report forms or via electronic data capture “may permit timely identification of clinical sites that require additional training, monitoring, or both. We expect that the pharmaceutical and device industries will, for the foreseeable future, continue to use some amount of on-site monitoring, although we anticipate decreased use of on-site monitoring with evolving monitoring methods and technological capabilities.”

Schuette encouraged sponsors to refer to two recent guidance documents on the use of centralized statistical monitoring as part of a risk-based monitoring plan: “[Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring?ref=fdaweb.com)” and “[A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/risk-based-approach-monitoring-clinical-investigations-questions-and-answers?ref=fdaweb.com).”

CDER Division of Analytics and Informatics statistician **Tina Wang** highlighted the agency’s experience with a centralized statistical monitoring tool under an ongoing Cooperative Research and Development Agreement (CRADA) with CluePoints Inc. The tool is used to identify problematic sites that exhibit data anomalies and possible data quality issues in multi-site clinical trials submitted to the agency to support the approval of new therapies.

For the CRADA, CDER is using study data tabulation model because it’s usually minimally processed and closer to the raw data, Wang said. “We used the Statistical Monitoring Applied to Research Trials, or SMART software, in the CRADA to check the consistency of collected data across all sites and identify those sites that differ substantially from others,” she said. “Using advanced data analytics, the software calculates a data inconsistency score for each site.”

To learn more about FDA’s experience with the centralized monitoring tool, Schuette and Wang co-authored a paper that can be viewed [here](https://www.tandfonline.com/doi/full/10.1080/10543406.2024.2330210?ref=fdaweb.com).