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# CluePoints, FDA Clinical Trial Site Selection Model
- URL: https://www.fdaweb.com/cluepoints-fda-clinical-trial-site-selection-model/
- Published: 2019-09-10T12:00:00.000Z
- Updated: 2026-09-15T01:48:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144961

CluePoints says that it and FDA have extended until 10/21 their cooperative research and development agreement (CRADA) that is exploring a data-driven approach to selecting clinical trial sites “which exhibit data anomalies indicative of fraud, misconduct or sloppiness.” Under the CRADA, FDA and CluePoints have developed and tested enhancements to the company’s existing software to produce an ordered list of “anomalous sites,” which it describes as sites whose data are highly inconsistent with data from other sites. The company’s selection tool has also been modified to add statistical tests and models, and the scoring system used was refined to identify outlying centers. The company says that it will continue to develop a user-friendly interface for use by medical reviewers and other interested parties at FDA.

CluePoints also says FDA plans to conduct statistical tests such as “key risk indicators” that will supplement the existing data-driven approach to selecting sites for inspection using a risk-based approach. The CRADA is also examining how the selection model can help determine the nature and extent of data anomalies, and the ability to explore the interaction of various factors with data quality. “These benefits are expected to not only accrue to the site inspection process and improve data quality for all reviewers, but may also inform the efforts of clinical and statistical reviewers to conduct sensitivity analyses, subgroup analyses and site by treatment effect explorations,” the company says.