CDISC Electronic Submission to FDA

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According to FDA Draft Guidance for Industry in Electronic Submission and Study Data Technical Conformance Guide, the pharmaceutical companies will need to provide CDISC Electronic submission to FDA. The paper will explain Data Standard Catalog which will dictate FDA Standards. The paper will discuss how to prepare CDISC electronic submission and what to prepare in CDISC electronic submission.

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  • I have a son who is 8 years old. Well, he start asking a lot of questions. Like why do I need to clean a play room? Sometimes, those questions are kind of annoying, but if I think about it, I have to agree with my son’s approaches. Whenever we need to do something, we may need to ask “Why”.

    One of the most popular TED talk given by Simon Sinek starts with Why. Simon Sinek inspired 17.5 million viewers with “Why” and he also introduced Golden circle. Whenever we need to do something, it starts with Why, How and What.

    Our talk today will approaches CDISC electronic submission with Why, How and What.
  • First, let’s us take a look at current status in electronic submission.
  • And, if we look at CDISC submission, FDA is also getting more of CDISC data.
  • The FDA Guidance document, once finalized, will be binding rather than recommendation.
  • It basically explain how the industry prepares electronic submission.

    Module 1 : contains administrative information and prescribing information. It has documents that are specific to each region, such as application forms or the labelling information for use in the region.
    Module 2 : contains high-level documents, which summarize the findings from each section of the submission or elements of the drug development process
    Module 3 : drug substance(active ingredients) and drug product (active ingredient plus and excipients, such as buffers, fillers and binders, that are used in the making of a pill, capsule, or liquid)
    Module 4 : contains animal study reports.
    Module 5 : contains clinical study information.

  • FDA Draft Guidance introduces a very important document. We believe that Data Standard Catalog is the central piece of all FDA standards.
  • FDA also introduces 4 time tables for standards
  • This won’t replace the communication between each sponsor and its FDA review division
  • Study Data Technical Conformance Guide also introduce Study Data Standardization Plan. CSS/PhUSE is currently working on developing Study Data Standardization Plan.
  • In addition, if we know what we will prepare for final FDA submission, it will help us to prepare all the parts early, rather than modifying them last minutes.
  • CDISC Electronic Submission to FDA

    1. 1. Accenture Accelerated R&D CDISC Electronic Submission to FDA Kevin Lee Clinical Data Strategies, Senior Consultant PharmaSUG 2014 Annual Conference
    2. 2. 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.
    3. 3. Why? 3© 2014 Accenture All Rights Reserved. What How Why
    4. 4. 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
    5. 5. Current Status in eSubmission in CDER FDA 5© 2014 Accenture All Rights Reserved.
    6. 6. Current Status in CDISC Submission in CDER FDA 6© 2014 Accenture All Rights Reserved. In 2010, 23% of SDTM in NDA In 2011, 39% of SDTM and 32% in ADaM in NDA In 2013, 55% of SDTM in NDA
    7. 7. 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.
    8. 8. New FDA Draft Guidance on CDISC eSubmission 8© 2014 Accenture All Rights Reserved. Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Standardized Study Data Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A (a) of the Federal Food Drug, and Cosmetic Act Binding rather than recommendation
    9. 9. 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
    10. 10. Electronic Common Technical Document 10© 2014 Accenture All Rights Reserved. • An interface for industry to agency transfer of regulatory information Introduction of eCTD File formats (i.e., pdf, txt, xml and xpt) • Module 1 – Administrative information • Module 2 – Summary document • Module 3 – Quality • Module 4 – Non-clinical Study Reports • Module 5 – Clinical Study Information Submission folder - modules and their contents
    11. 11. 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 Standard Exchange Format Supported Version Implementation Guide Reference FDA Center Date Support Begins (yyyy-mm-dd) Date Support Ends (yyyy-mm-dd) Date Requirement Begins Date Requirements Ends SDTM XPT 1.3 3.1.3 CBER, CDER 2012-12-01 SDTM XPT 1.2 3.1.2 Amendment 1 CBER, CDER 2013-08-07 SDTM XPT 1.2 3.1.2 CBER, CDER 2009-10-30 SDTM XPT 1.1 3.1.1 CBER, CDER Ongoing 2015-01-28 ADaM XPT 2.1 1.0 CBER, CDER Ongoing SEND XPT 1.2 3.1.2 CDER 2011-06-13 Define XML 2.0 N/A CBER, CDER, CDRH 2013-08-07 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.
    12. 12. Timetables for Standards 12© 2014 Accenture All Rights Reserved. New Format (with 24 months Implementation Period) New Format (with 36 months Implementation Period) Update to Required Format (with 12 months Implementation Period) Correction to Required Format (with 2 weeks Implementation Period)
    13. 13. Standard Exchange Format Support ed Version Implementati on Guide Reference FDA Center Date Support Begins (yyyy-mm-dd) Date Support Ends (yyyy-mm- dd) Date Requireme nt Begins Date Requireme nts Ends SDTM XPT 4.1 CBER, CDER 2016-05-06 2018-03- 15 Timetable Example (Update – 12 months Implementation) 13© 2014 Accenture All Rights Reserved. 2016-02-15 • CDISC Version Update of SDTM from 4.0 to 4.1 2016-05-06 • FDA Date Support on SDTM 4.1 2017-03-15 • FDA Effective Implementation Date of SDTM 4.1 2018-03-15 • FDA Requirement Date of SDTM 4.1 Data Standards Catalog
    14. 14. Study Data Technical Conformance Guide 14© 2014 Accenture All Rights Reserved. • Provides specifications, recommendations and general consideration on Standardized data in Data Standards Catalog • Supplements eStudy Data Guidance • Non-binding documents Background • Provides technical recommendation on standard data in IND, NDA, ANDA and BLA. • Complement and promote interactions between sponsors and FDA Purpose
    15. 15. 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
    16. 16. CDISC Clinical Trial Process 16© 2014 Accenture All Rights Reserved. PRN (Protocol) eCRF ODM.xml, LAB SDTM TFLADaM SAP CDASH CSR CT Define.xml FDA Submission Components
    17. 17. Study Data Standardization Plan 17© 2014 Accenture All Rights Reserved. At pre-IND stage in 1.13.9 general investigational plan List of the planned studies Type of Studies Study Design Planned Data Standards, formats and terminologies and their revisions List of and justification for studies that may not conform to the standards
    18. 18. Study Data Reviewer’s Guide (SDRG) 18© 2014 Accenture All Rights Reserved. Study Protocol title, number and version Study Design Standards, formats and terminologies and their versions Description of study datasets Data Standards conformance validation rules, versions and issues
    19. 19. Format of Electronic Files according to eCTD 19© 2014 Accenture All Rights Reserved. Protocol • pdf (i.e., study001-protocol.pdf) SAP • pdf (i.e., sutdy001-sap.pdf) eCRF • pdf (i.e., blankcrf.pdf) SDTM • xpt (i.e., dm.xpt, ae.xpt, and ds.xpt) ADaM • xpt (i.e., adsl.xpt, adae.xpt, and adtteos.xpt) SEND • xpt (i.e., dm.xpt, se.xpt, and bw.xpt) CSR • pdf (i.e., sutdy001-csr.pdf) Define • xml or pdf (i.e., define.xml/define.pdf) ADaM SAS programs • txt (i.e., c-adsl-sas.txt) Efficacy SAS programs • txt (i.e., t-14-01-001-ds-sas.txt ) SDRG/ADRG • pdf (study001-study-data-reviewer-guide.pdf)
    20. 20. Naming Conventions of Electronic Files According to eCTD 20© 2014 Accenture All Rights Reserved. Lower case of letter from “a” to “z” (i.e., ae.xpt) Number from “0” to “9” “-” hypen (i.e., c-adae-sas.txt) No special character ( #, %, $ and etc) File name should be less than or equal to 64 characters including the appropriate file extension The length of entire path of the file should not exceed 230 characters. (m5/datasets/study001/tabulations/sdtm/ae.xpt)
    21. 21. pdf File Guidance according to eCTD 21© 2014 Accenture All Rights Reserved. Version – 1.4 thru 1.7 are acceptable • Standard : Arial, Courier New, Times Roman • Sizes : range from 9 to 12 point ( Times New Roman 12-point font is recommended for narrative text ) Fonts • Print area : 8.5 inches by 11 inches • Margin : at least ¾ inch Page
    22. 22. xpt File Formats Guidelines 22© 2014 Accenture All Rights Reserved. • Variable length is less than or equal to 8 • Variable label is less than or equal to 40 • Dataset length is less than or equal to 8 • Dataset label is less than or equal to 40 Length • less than 1 GB (LB1, LB2, and so on) Dataset Size • should be minimized – i.e, if the maximum length of USUBJID is 20 character long, keep the length as 20, not 200. The length of character variables
    23. 23. Reports in module 5.3.1.1 of eCTD 23© 2014 Accenture All Rights Reserved. CSR, SAP, Protocol, CRF
    24. 24. 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
    25. 25. Waiver Criteria for FDA Standards 25© 2014 Accenture All Rights Reserved. Discuss the waiver request with FDA prior to or at the pre- IND meeting and submit the request in writing prior to submission. A written waiver request • The specific requirements that sponsors seek for waivers • A necessary reason • A description of the alternatives No Waivers, but sponsors may apply for it
    26. 26. FDA Support 26© 2014 Accenture All Rights Reserved. – Study Data Technical Conformance Guide: non-binding – Sponsor can arrange pre-submission technical review on sample data Implementation Support – Study Data Standardization Plan – Data Standardization Issues Meeting with FDA on pre-IND or prior to end-of-phase 2
    27. 27. 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.
    28. 28. 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
    29. 29. Questions and Discussion 29© 2014 Accenture All Rights Reserved.

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