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CBER Data Standards Management

CBER Data Standards Management. Presented to : DC CDISC Group April 25, 2014. Agenda. CBER Data Standards Management CBER Data Standards Project Portfolio Focus for Addressing Mandates and Processing Gaps for CDISC Data Standards. 2. Role of Data Standards.

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CBER Data Standards Management

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  1. CBER Data Standards Management Presented to: DC CDISC Group April 25, 2014

  2. Agenda • CBER Data Standards Management • CBER Data Standards Project Portfolio • Focus for Addressing Mandates and Processing Gaps for CDISC Data Standards 2

  3. Role of Data Standards • FDA recognizes the need for standards to support standardization of industry regulatory submissions and to enable data reuse and cross reference throughout a product’s life cycle • Data standards support the need for functional interoperability across FDA core functions which issimplifiedas: “Data contained in disparate regulatory submissions is reused to support another regulatory function without having to understand how the source data was collected or the need to log into different systems to validate the same information” 3

  4. Data Standards Groups 4

  5. CBER Data Standards Subcommittee (DSS) • Provides a formal governance and project management process for data standards projects with interdependencies with FDASIA and user fee program goals for: • IT systems, especially support for structured electronic regulatory submissions • Business process changes as a result of new tools and systems • Regulatory policy changes: new or updated industry guidance to use the data standards • Data standards: development, testing, adoption and implementation • Projects are categorized by a Data Standards Lifecycle Phase 5

  6. CBER DSS Governance Relationships • CBER Information Management Coordinating Committee (IMCC) oversight ensures that DSS projects align with CBER’s IT Strategic Plan goals for projects that have IT interdependencies: 1. Information Management 2. Innovation 3. Partnerships • CBER Review Management Coordinating Committee (RMCC) coordination ensures that DSS projects align for interdependencies with CBER business processes and regulatory policies • Center-level informatics coordination ensures that DSS projects align with Agency/Center priorities and goals pertaining to Regulatory Science and Research 6

  7. CBER Data Standards Portfolio • Active projects are near term activities that require CBER review experts and IT resources that must be accounted for (e.g., project plans and budget submissions for IT systems or contractor support) • Some projects pertain to other Agency/non-CBER initiatives that require close monitoring, e.g., FDASIA or MDUFA • Projects are grouped by data standards lifecycle phase and include touch points for: • IT systems • Regulatory policy/guidance documents • Business process changes • Interactions with other internal/external groups 7

  8. CBER Standards Portfolio by Working Group, Lifecycle Phase and IT Strategic Goal Area 8

  9. Operations and Maintenance Phase Performance monitoring helps to identify problems and issues from the review community – Process improvements help to address regulatory requirements for data reuse and linking, e.g., pre and post market safety reports 9

  10. Center Informatics Monitoring Projects Resources are repurposed for multiple projects but still cannot monitor everything we know about. Some review SMEs also monitor external groups: e.g., PhUSE, CPATH, CFAST, TransCelerateBioPharma 10

  11. CBER Data Standards Challenges • CBER is relatively small Center and we have a very diverse product portfolio: • NDA • BLA • 510(K) • PMA • CBER must account for a wider variety of data standards applicability to different regulatory/legislative drivers which may not overlap • FDA • CDC • Requires CBER to work more collaboratively internally and externally • Regulatory Use Cases • Public Health Research and Reporting 11

  12. Mandates and Submissions Processing Gaps • PDUFA commitments state that FDA will require electronic submission of study data by 2017; however • CBER has identified several support gaps that must be addressed before this can be accomplished: • Understanding the business impact based upon review workload • Addressing known errors and inconsistencies in standards adoption • Understanding training requirements by review discipline • Closing the gap between development and implementation based upon tangible FDA business needs • Automation of submission receipt tracking and validation processes • Subject to other User Fee Programs: BsUFA, MDUFMA, GDUFA 12

  13. PDUFA Business Impact by Review Workload Number of CDISC Submissions by CY

  14. Submissions by Product Type

  15. Standards Adoption and Use: Top 7 Errors

  16. Near Term Activities • Consistent project management process for CBER CDISC Workgroup: • Focus on managing activities by data standards lifecycle to meet agency mandates • Focus on meeting specific review needs by review discipline • Slow down development and monitoring tasks • Address long term training needs • Implement formal process for adoption and migration planning • Limit portfolio projects to what we can manage with operational excellence • Focus on addressing the operational issues with standards use by reducing errors and providing clear guidance (internal and external) about the data needed for review and data reuse 16

  17. Background Slides DC-CDISC Group Meeting April 25, 2014

  18. Data Standards Lifecycle Phases Engage SDO: If standard no longer meets CBER requirements, propose major revision or new standards project Development: Create new or major revision of existing standard to address a specific regulatory need: data exchange, content, terminology. Includes SDO balloting and/or collaboration with internal/external stakeholders Testing:Simulate regulatory use case by applying the standard to the business problem. Includes creation of test tools used by industry and/or FDA reviewers. Assessment of performance and success criteria Performance Monitoring: Ensure standard continues to meet business needs and adjust to changing environment Adoption:Center “go/no go” decision based upon testing results and success criteria Operations and Maintenance:Leverage CBER CCB process to maintain systems for continued standards use Implementation: Execute processes to integrate standard into business practice: review, IT, regulatory policy 18

  19. CBER DSS Standards Portfolio Data standards categories are used to help determine resource requirements for each project: 19

  20. Data Standards Monitoring • DSS does not manage data standards monitoring activities • Monitoring activity still requires CBER resource commitments: • CBER Subject Matter Experts in review offices and ADRM • Participation in meetings and teleconferences/webinars • Review of documents against FDA business requirements • If an Agency, non-CBER or SDO project appears to be on an expedited timeframe that will have a future impact on CBER’s business, then projects are reprioritized and may be moved to the DSS active project portfolio: • CDRH: Unique Device Identifiers • CDER: CDISC Therapeutic Area Standards (TA) • ISO IDMP Implementation Guides • Coordination is managed and tracked under the Center Informatics Group with updates to DSS, IMCC and RMCC as appropriate 20

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