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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. - PowerPoint PPT Presentation



CBER Data Standards ManagementPresented to:DC CDISC GroupApril 25, 2014

1AgendaCBER Data Standards ManagementCBER Data Standards Project PortfolioFocus for Addressing Mandates and Processing Gaps for CDISC Data Standards

22Role of Data StandardsFDA recognizes the need for standards to support standardization of industry regulatory submissions and to enable data reuse and cross reference throughout a products life cycle

Data standards support the need for functional interoperability across FDA core functions which is simplified as:

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


3Data Standards Groups45CBER 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 submissionsBusiness process changes as a result of new tools and systemsRegulatory policy changes: new or updated industry guidance to use the data standardsData standards: development, testing, adoption and implementation

Projects are categorized by a Data Standards Lifecycle Phase

6CBER DSS Governance RelationshipsCBER Information Management Coordinating Committee (IMCC) oversight ensures that DSS projects align with CBERs 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

CBER Data Standards PortfolioActive 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 systemsRegulatory policy/guidance documentsBusiness process changesInteractions with other internal/external groups

7CBER Standards Portfolio by Working Group, Lifecycle Phase and IT Strategic Goal Area

88Operations and Maintenance Phase9Performance 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 reports9Center Informatics Monitoring ProjectsResources 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, TransCelerate BioPharma1010CBER Data Standards ChallengesCBER is relatively small Center and we have a very diverse product portfolio:NDABLA510(K)PMA

CBER must account for a wider variety of data standards applicability to different regulatory/legislative drivers which may not overlapFDACDCRequires CBER to work more collaboratively internally and externallyRegulatory Use CasesPublic Health Research and Reporting

11Mandates and Submissions Processing GapsPDUFA 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 workloadAddressing known errors and inconsistencies in standards adoptionUnderstanding training requirements by review disciplineClosing the gap between development and implementation based upon tangible FDA business needsAutomation of submission receipt tracking and validation processes

Subject to other User Fee Programs: BsUFA, MDUFMA, GDUFA

12PDUFA Business Impact by Review WorkloadINDNDABLATOTAL 2131377662934PDUFA WORKLOAD20044169217713Number of CDISC Submissions by CYJAN-DECJAN-APR201220132014TOTAL Unknown302050*Based upon file validation tracking13Submissions by Product TypeTypeADaMSDTMTOTAL Vaccines123Blood Derivatives173047Cell/Tissue/Gene Therapy000*Allergenic products are exempt 14Standards Adoption and Use: Top 7 Errors15Error TypeDescriptionCDISC Validator Business RulesConsistencyInconsistent value for standard units of measurementSD0007PresenceNULL value in variable marked as requiredSD002Terminology Value for AECONTRT not found in (NY) CT codelistCT0070Metadata Dataset variable not defined in define.xmlSD0059Coss-referenceInvalid ARM/ARMCDSD0071FormatInvalid ISO 8601 valueSD1011LimitNegative value for --DURSD0015Near Term ActivitiesConsistent project management process for CBER CDISC Workgroup:

Focus on managing activities by data standards lifecycle to meet agency mandatesFocus on meeting specific review needs by review disciplineSlow down development and monitoring tasksAddress long term training needsImplement formal process for adoption and migration planningLimit portfolio projects to what we can manage with operational excellenceFocus 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 reuse16Background SlidesDC-CDISC Group MeetingApril 25, 2014Data Standards Lifecycle PhasesDevelopment: 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 criteriaAdoption: Center go/no go decision based upon testing results and success criteria

Implementation: Execute processes to integrate standard into business practice: review, IT, regulatory policy

Operations and Maintenance: Leverage CBER CCB process to maintain systems for continued standards use

Performance Monitoring: Ensure standard continues to meet business needs and adjust to changing environmentEngage SDO: If standard no longer meets CBER requirements, propose major revision or new standards project

1818CBER DSS Standards PortfolioData standards categories are used to help determine resource requirements for each project:19Standards TypeDefinitionExampleData Exchange Content and format in which particular types of data are to be presented and exchanged. Data exchange standards include file format specificationsStructured Product Labeling (SPL)Data Format Structure, content, naming conventions, and variable formats for any given data domainSAS transport files (SAS XPT)TerminologyControlled vocabularies to improve communications and enhance analytical capabilitiesStandardized terms for anatomical body sitesData Standards Monitoring DSS does not manage data standards monitoring activitiesMonitoring activity still requires CBER resource commitments:CBER Subject Matter Experts in review offices and ADRMParticipation in meetings and teleconferences/webinarsReview 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 CBERs business, then projects are reprioritized and may be moved to the DSS active project portfolio:CDRH: Unique Device IdentifiersCDER: 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



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