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FDA Makes Recommendations for Study Data Plans


Federal Register Notice: FDA is making available draft recommendations for preparing a Study Data Standardization Plan. It is referenced in the Study Data Technical Conformance Guide, which supplements the guidance for industry, Providing Regulatory Submissions in Electronic Format — Standardized Study Data. The guidance provides specifications, recommendations, and general considerations on submitting standardized study data using FDA-supported data standards. The guide recommends that, for clinical and nonclinical studies, sponsors include a plan that describes the submission of standardized study data to FDA. The proposed recommendations describe the information that should be included in the Standardization Plan. The proposed recommendations for creating a Standardization Plan are posted on FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

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