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
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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 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”
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Data Standards Groups
• Representatives are Center/Agency SMEs: Electronic Health Record and Health Information Technology (HIT) Standards
• Representatives are Center/Agency SMEs: CDISC, HL7, ICH, ISO
• Center SME liaisons to FDA Data Standards Council and FDA Standards Management Group
• Center Subject Matter Experts (SMEs)that are repurposed for multiple internal/external standards activities Center Data
Standards Groups: DSS, CDER DSPB
Agency Data Standards
Groups
HHS OPDIV Collaboration
s and ONC workgroups
International and /External
Standards Development Organizations
(SDOs)
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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
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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
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
CBER Standards Portfolio by Working Group, Lifecycle Phase and IT Strategic Goal Area
Data Standards SubcommitteeCBER CDIS
C
Development & Testing
CDISC Data Submission
XML Pilot
Post Market Submissions
Implementation
eVAERS / ICSR
(IT, Regulatory Policy,
Business Process)
Adoption
ICH E2B(R3) IDMP
Adoption (for ICSR)
FDA IDMP
Adoption
ISO IDMP Implementatio
n Guides (ISO 11238)
ISO IDMP Maintenance
FDA SRS Redesign
Product Dictionary/
Integrity
Regulated Product
Submissions
Development & Testing
IMDRF: RPS for Medical
DevicesICH M8: eCTD v4.0 Project
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Operations and Maintenance Phase
Operations and Maintenance Activity
Electronic Submissions Formats
SDTM 3.1.1
through 3.1.3
ICH E2B-R2
SPL ADaM 2.1 eCTD
Regulatory Policy & Guidance Documents
eLDD eCTD
eSubs & FDASIA
eStudy Data
Study Data
Standards Technical
Guide
eSRR
Reviewer/Industry Training and Support
JReview Dataset
s loading request
s
TrainingCBER
Website, SOPs
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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
Center Informatics Monitoring Projects
Data Standards Monitoring ActivityExternal SDO Work
CDISC
CDASH
TA Standards Initiative Project
Plan
SDTM 3.1.4
HL7
RCRIM RPS, SPL
Pharmacy:
Common Product Model
Public Health
Reporting
Electronic Health
Records
ISO TC 215 Workgroup 6
ICSR Technical
ReportIDMP
Standards
IMDRF
IMDRF Device Table of
Contents
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, TransCelerate BioPharma
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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
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, GDUFA12
PDUFA Business Impact by Review Workload
IND NDA BLA TOTAL 2131 37 766 2934
PDUFA WORKLOAD2004 4 169 2177
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Number of CDISC Submissions by CY
JAN-DEC JAN-APR2012 2013 2014 TOTAL
Unknown 30 20 50*Based upon file validation tracking
Submissions by Product TypeType ADaM SDTM TOTAL
Vaccines 1 2 3Blood
Derivatives17 30 47
Cell/Tissue/Gene Therapy
0 0 0
*Allergenic products are exempt
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Standards Adoption and Use: Top 7 Errors
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Error Type Description CDISC Validator Business Rules
Consistency Inconsistent value for standard units of measurement
SD0007
Presence NULL value in variable marked as required
SD002
Terminology Value for AECONTRT not found in (NY) CT codelist
CT0070
Metadata Dataset variable not defined in define.xml
SD0059
Coss-reference Invalid ARM/ARMCD SD0071
Format Invalid ISO 8601 value SD1011
Limit Negative value for --DUR SD0015
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
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Background Slides
DC-CDISC Group MeetingApril 25, 2014
Data 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 criteria
Adoption: 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 environment
Engage SDO: If standard no longer meets CBER requirements, propose major revision or new standards project
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CBER DSS Standards PortfolioData standards categories are used to help determine resource requirements for each project:
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Standards Type Definition ExampleData Exchange Content and format in
which particular types of data are to be presented and exchanged. Data exchange standards include file format specifications
Structured Product Labeling (SPL)
Data Format Structure, content, naming conventions, and variable formats for any given data domain
SAS transport files (SAS XPT)
Terminology Controlled vocabularies to improve communications and enhance analytical capabilities
Standardized terms for anatomical body sites
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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