PPT-CDISC SDTM IG for Associated Persons 1.0 Overview March 2016 – DC CDISC user group

CDISC SDTM IG for Associated Persons 10 Overview March 2016 DC CDISC user group Michael DiGiantomasso 1 Foreword Data about people not in the study that could affect study subjects . ADaM. standard. 1. FDA/. PHuSE. . ADaM. Kick off Meeting. 2. Location in the . CDISC Standards. 3. Clinical trial data and information flow. See example of HERA . analysis . plan. Analysis Datasets and . Working Group Update. Metadata Definitio. n. 2. Leader: Isabelle . deZegher. No . formal meeting . Finalize document through TC . – . Available Apr2014. Leader: Geoff Low. Review the current draft model. Data . in . ImmPort. Barry Smith. http://ontology.buffalo.edu/smith. 1. pipeline. 2. perform . study . &. collect . data. analyze data. (SAS …). submit . data to. ImmPort. process & . de-identify, . what happened…. Kevin Kane, . PHASTAR. kevink@phastar.co.uk. FDA / PhUSE CSS Initiative. FDA sponsored collaborative meeting with PhUSE and CDISC partners. "Update on Standards, Tools, Process Initiatives across Regulatory Review and Collaboration with Key Working Groups to Improve the Product Lifecycle. 21. st. June 2017. PhUSE. Alternative Transport Format Working Group. What was the Alt. Trans. Group. Bought together at the behest of industry to relook at the choice of format for transporting Datasets (as an alternative to the SAS XPT v5 format). Solid profitability, Nav 310p per . share -(. March 2016. ). Record cash reserves £. 15.1m - (. March 2017. ). Interim Non-Executive . Chairman . Je. r. emy Brade . Chief . Executive . John Foster . FOR . MALARIA. C. linical . D. ata . I. nterchange . S. tandards . C. onsortium (CDISC). W. orld. W. ide. . A. ntimalarial . R. esistance . N. etwork (WWARN) . Lesley Workman. CRC, 16 February, 2016. FOR . MALARIA. C. linical . D. ata . I. nterchange . S. tandards . C. onsortium (CDISC). W. orld. W. ide. . A. ntimalarial . R. esistance . N. etwork (WWARN) . Lesley Workman. CRC, 16 February, 2016. Standard Scripts. . Proposal through CSS . 2014. http://. www.phusewiki.org/wiki/index.php?title=File:FDA_Scrips.ppt. Anyone should be able to submit a script, according to a check list. Categorize scripts according to complexity. AGENDABackgroundSystem FeaturesData Collection ScreensTransition WHAT IS A CTDMS?CTDMS = Clinical Trials Data Management Systembased solutions for managing clinical trials dataOne location for managin Sydney 2013. Agenda. N. eurosurgical topics for the MDS meeting in 2014. Symposium . title. Suggested . Session Chair. The . names of 3 possible speakers. Tentative . presentation titles for each speaker . Bhavin and Mikkel. PoC for Study Design and Configuration using CDISC 360 Concept-based Standards – . Mikkel and Nicolas. Automation of SDTM & ADaM Generation and Artifacts using CDISC 360 Enriched Metadata – . Senior Product Manager for Health and Life Sciences. Sam.Gardner@JMP.com. What is JMP Clinical?. JMP Clinical is a focused and specialized product for Clinical Trial data review. . We give users “straight out-of-the-box” functionality to do thorough reviews of clinical trials at the study, site, and subject level.