Transcription of Optimizing Your Study Data Submissions to FDA Updates …
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Optimizing Your Study Data Submissions to FDA Updates …
This single PDF file contains the slides for all threepresentationsin the webinar: Optimizing your Study data Submissions to FDA Updates from CDER and on the Study data Technical Conformance GuideRon Fitzmartin, PhD, MBAS enior AdvisorOffice of Strategic ProgramsCenter for Drug Evaluation and Food and Drug AdministrationJuly 13, 2017 CDER SBIA Webinar Series3 The views and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the Food and Drug Administration. FDA DISCLAIMER4 Study data Standards:Road Ahead and the Road Left Behind52012 FDASIA amended FD&C Act added Sec 745A (21 USC 379 k-1(a))FDA Statute to Require data Standards FDASIA 745A(a)GuidanceHow FDA will implement individual Binding Guidances6 Focus is on helping sponsors & applicants to submit better standardized data .
Optimizing Your Study Data Submissions ... annotated Case Report Form (aCRF) for Study Data Tabulation Model (SDTM) •Use of SDTM DOMAINS for vaccine clinical study data •Understanding where errors have occurred in SDTM datasets and how to avoid them •Traceability of data
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Introduction, Study Data Tabulation Model, Data, Study Data, Critique of Implementing the Submission Data Tabulation, ADAS-Cog Questionnaire Supplement, 1451-2014 Converting Clinical Database to, CDISC standards, Short Form, Columbia-Suicide Severity Rating Scale Baseline, Metadata Submission Guidelines Appendix to, Data Tabulation Model, Study