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Accenture Accelerated R&D CDISC Electronic Submission to FDA Kevin Lee Clinical Data Strategies, Senior Consultant

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Accenture Accelerated R&D CDISC Electronic Submission to FDA Kevin Lee Clinical Data Strategies, Senior Consultant PharmaSUG 2014 Annual Conference


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Disclaimer Any views or opinions presented in this presentation are solely those of the author and do not necessarily represent those of the company. 2 © 2014 Accenture All Rights Reserved.


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Why? 3 © 2014 Accenture All Rights Reserved.


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Agenda 4 © 2014 Accenture All Rights Reserved. Why do we care CDISC electronic submission? How can we prepare CDISC electronic submission? What do we prepare CDISC electronic submission? Conclusion Questions & Answers


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Current Status in eSubmission in CDER FDA 5 © 2014 Accenture All Rights Reserved.


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Current Status in CDISC Submission in CDER FDA 6 © 2014 Accenture All Rights Reserved.


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Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 7 © 2014 Accenture All Rights Reserved. Enhanced by Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012. Requires that submissions be submitted in electronic format.


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New FDA Draft Guidance on CDISC eSubmission 8 © 2014 Accenture All Rights Reserved.


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How to prepare CDISC eSubmission 9 © 2014 Accenture All Rights Reserved. eCTD(Electronic Common Technical Document) Data Standard Catalog CDISC Standards Study Data Technical Conformance Guide


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Electronic Common Technical Document 10 © 2014 Accenture All Rights Reserved.


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Data Standards Catalog 11 © 2014 Accenture All Rights Reserved. Data Standards Catalog Standards Type and Version (i.e., eCTD, xml, SDTM 1.3, ADaM 2.1, Define.xml 2) FDA Center (i.e., CBER, CDER, CDRH) FDA Support start and end date FDA Requirement start and end date SDTM 1.3 and SDTM IG 3.1.3 is accepted on CBER and CDER from 2012-12-01 on xpt format. SDTM 1.1 and SDTM IG 3.1.1 will be no longer accepted on CBER and CDER from 2015-01-28.


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Timetables for Standards 12 © 2014 Accenture All Rights Reserved.


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Timetable Example (Update – 12 months Implementation) 13 © 2014 Accenture All Rights Reserved. Data Standards Catalog


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Study Data Technical Conformance Guide 14 © 2014 Accenture All Rights Reserved.


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What to prepare for CDISC eSubmission 15 © 2014 Accenture All Rights Reserved. CDISC components according to Data Standard Catalog Its electronic formats according to eCTD


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CDISC Clinical Trial Process 16 © 2014 Accenture All Rights Reserved. PRN (Protocol) eCRF ODM.xml, LAB SDTM TFL ADaM SAP CDASH CSR CT Define.xml FDA Submission Components


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Study Data Standardization Plan 17 © 2014 Accenture All Rights Reserved.


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Study Data Reviewer’s Guide (SDRG) 18 © 2014 Accenture All Rights Reserved.


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Format of Electronic Files according to eCTD 19 © 2014 Accenture All Rights Reserved.


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Naming Conventions of Electronic Files According to eCTD 20 © 2014 Accenture All Rights Reserved.


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pdf File Guidance according to eCTD 21 © 2014 Accenture All Rights Reserved.


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xpt File Formats Guidelines 22 © 2014 Accenture All Rights Reserved.


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Reports in module 5.3.1.1 of eCTD 23 © 2014 Accenture All Rights Reserved. CSR, SAP, Protocol, CRF


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CDISC Datasets in module 5.datasets 24 © 2014 Accenture All Rights Reserved. ADaM xpt datasets, Define.xml, ADRG ADaM SAS programs, TFL SAS programs SDTM xpt datasets, Define.xml, SDTM annotated blank CRF, SDRG Any xpt datasets Patient profile


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Waiver Criteria for FDA Standards 25 © 2014 Accenture All Rights Reserved.


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FDA Support 26 © 2014 Accenture All Rights Reserved.


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Conclusion 27 © 2014 Accenture All Rights Reserved. Before : “should” in FDA documents means that something is suggested or recommended, but not required. After : “should” in Guidance for Industry in Electronic Submission means required. It is better to start with the end in minds.


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Contact Information 28 © 2014 Accenture All Rights Reserved. Email address : kevin.s.lee@accenture.com Linkedin Profile : www.linkedin.com/in/HelloKevinLee/ Tweet : @HelloKevinLee Slide share : http://www.slideshare.net/KevinLee56 Blogs : HiKevinLee.tumbrl.com


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Questions and Discussion 29 © 2014 Accenture All Rights Reserved.


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