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This working group will focus on continuing the ongoing work developing standards for the data set used in a risk model designed to improve the quality of clinical inspection site selection for drug trials. This working group will discuss ways to incorporate the site selection tool data set variables into existing standards and identify potential standardized methods for both the industry and FDA to develop the data sets in the specified format.

Pages in category "WG2"

The following 4 pages are in this category, out of 4 total.