Accenture Accelerated R&DCDISC Electronic Submission to FDAKevin LeeClinical Data Strategies, Senior Consultant презентация

Содержание

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

Слайд 1Accenture Accelerated R&D CDISC Electronic Submission to FDA Kevin Lee Clinical Data Strategies, Senior

Consultant

PharmaSUG 2014 Annual Conference


Слайд 2Disclaimer
Any views or opinions presented in this presentation are solely those

of the author and do not necessarily represent those of the company.

© 2014 Accenture All Rights Reserved.


Слайд 3Why?
© 2014 Accenture All Rights Reserved.


Слайд 4Agenda
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Why do we care CDISC electronic

submission?
How can we prepare CDISC electronic submission?
What do we prepare CDISC electronic submission?
Conclusion
Questions & Answers

Слайд 5Current Status in eSubmission in CDER FDA
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Reserved.



Слайд 6Current Status in CDISC Submission in CDER FDA
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Rights Reserved.

Слайд 7Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C

Act)

© 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.


Слайд 8New FDA Draft Guidance on CDISC eSubmission
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Reserved.

Слайд 9How to prepare CDISC eSubmission
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eCTD(Electronic Common

Technical Document)
Data Standard Catalog
CDISC Standards
Study Data Technical Conformance Guide

Слайд 10Electronic Common Technical Document
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Слайд 11Data Standards Catalog
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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.


Слайд 12Timetables for Standards
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Слайд 13Timetable Example (Update – 12 months Implementation)
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Reserved.

Data Standards Catalog


Слайд 14Study Data Technical Conformance Guide
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Слайд 15What to prepare for CDISC eSubmission
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CDISC

components according to Data Standard Catalog
Its electronic formats according to eCTD

Слайд 16CDISC Clinical Trial Process
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PRN (Protocol)
eCRF
ODM.xml, LAB
SDTM



TFL
ADaM


SAP

CDASH

CSR

CT


Define.xml



FDA

Submission Components



Слайд 17Study Data Standardization Plan
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Слайд 18Study Data Reviewer’s Guide (SDRG)
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Слайд 19Format of Electronic Files according to eCTD
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Reserved.

Слайд 20Naming Conventions of Electronic Files According to eCTD
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Rights Reserved.

Слайд 21pdf File Guidance according to eCTD
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Слайд 22xpt File Formats Guidelines
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Слайд 23Reports in module 5.3.1.1 of eCTD
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CSR,

SAP, Protocol, CRF

Слайд 24CDISC Datasets in module 5.datasets
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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


Слайд 25Waiver Criteria for FDA Standards
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Слайд 26FDA Support
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Слайд 27Conclusion
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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.

Слайд 28Contact Information
© 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

Слайд 29Questions and Discussion
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