Transcription of A Brief Introducon to CDISC – SDTM and Data Mapping
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A Brief Introducon to CDISC – SDTM and Data Mapping
A Brief Introduc/on to CDISC SDTM and Data Mapping 5/3/10 2 Agenda Copyright 2010, Cytel Sta7s7cal So:ware & Services Pvt. Ltd. All Rights Reserved. Flow of Clinical Trials Data The Problem Introducing CDISC Understanding SDTM Concepts of Data Mapping References 5/3/10 3 Flow of Clinical Trials Data Copyright 2010, Cytel Sta7s7cal So:ware & Services Pvt. Ltd. All Rights Reserved. Protocol CRF Design Actual Trial (Patient data collected in CRFs) CDM (Patient data in CRFs converted to Raw Datasets) Raw Datasets Create Analysis Datasets Create TLFs FDA Submission/Review 5/3/10 4 The Problem Copyright 2010, Cytel Sta7s7cal So:ware & Services Pvt. Ltd. All Rights Reserved. Protocol CRF Design Actual Trial (Patient data collected in CRFs) CDM (Patient data in CRFs converted to Raw Datasets) Raw Datasets Create Analysis Datasets Create TLFs FDA Submission/Review LACK OF standards 5/3/10 5 Introducing CDISC Copyright 2010, Cytel Sta7s7cal So:ware & Services Pvt.
Standards Consorum (CDISC) 1. Development of industry standards to support the a) electronic acquision b) exchange c) submission and d) archiving of clinical trials data 2. Development of global, plaorm independent standards 5. Improve data quality and accelerate
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