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FDA Reviewer Template Warehouse System (RTWS)
GNSI has been working with the Office of Women’s Health (OWH) at the Food and Drug Administration (FDA) to develop the Reviewer Template Warehouse System (RTWS). One of the mandates of OWH is to monitor the inclusion of women and gender analysis in clinical trials and to work to correct any identified gender disparities in drug, device, and biologics testing, and regulation policy. RTWS is a direct response to this mandate. RTWS is intended to store in a structured data format the valuable knowledge gained from the analysis, findings, and content of a review document for a new drug application.
GNSI has developed for OWH a review template in Microsoft Word that leverages the SMART Document technology introduced in MS Office 2003. These SMART Document templates capture reviewer analysis in an XML format and at the same time provide a consistent format for reviews across the Agency. Template specific functionality is made available using the .NET framework to provide template navigation and ease of use. These SMART Document templates are currently being piloted by drug application reviewers in the Center for Drug Evaluation and Research. The second phase of the project will pilot storage of the reviews in a data warehouse and re-use of review content for data mining and reporting purposes.