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
• Center Subject
Matter Experts
(SMEs)that are
repurposed for
multiple
internal/external
standards activities
• Representatives are
Center/Agency
SMEs: CDISC, HL7,
ICH, ISO
Center Data
Standards
Groups: DSS,
CDER DSPB
Agency Data
Standards
Groups
International
and /External
Standards
Development
Organizations
(SDOs)
HHS OPDIV
Collaborations
and ONC
workgroups
• Center SME
liaisons to FDA
Data Standards
Council and FDA
Standards
Management
Group
• Representatives are
Center/Agency SMEs:
Electronic Health Record
and Health Information
Technology (HIT)
Standards
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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
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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
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– Interactions with other internal/external groups
CBER Standards Portfolio by Working Group, Lifecycle Phase
and IT Strategic Goal Area
Data Standards Subcommittee
CBER
CDISC
Development &
Testing
CDISC Data
Submission
XML Pilot
Post Market
Submissions
Implementation
Adoption
eVAERS / ICSR
(IT, Regulatory
Policy, Business
Process)
ICH E2B(R3)
IDMP Adoption
(for ICSR)
ISO IDMP
Implementation
Guides
(ISO 11238)
FDA IDMP
Regulated
Product
Submissions
Adoption
Development & Testing
ISO IDMP
Maintenance
FDA SRS
Redesign
Product
Dictionary/
Integrity
IMDRF: RPS for
Medical Devices
ICH 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- SPL
R2
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
Datasets Training
loading
requests
CBER
Website,
SOPs
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
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Center Informatics Monitoring Projects
Data Standards Monitoring Activity
External SDO Work
CDISC
CDASH
TA
Standards
Initiative
Project
Plan
ISO TC 215
Workgroup 6
HL7
SDTM
3.1.4
RCRIM
RPS, SPL
Pharmacy:
Common
Product
Model
Public
Health
Reporting
Electronic
Health
Records
ICSR
Technical
Report
IDMP
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
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– Public Health Research and Reporting
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
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PDUFA Business Impact by Review
Workload
IND
NDA
BLA
TOTAL
2131
37
766
2934
PDUFA WORKLOAD
2004
4
169
2177
Number of CDISC Submissions by CY
JAN-DEC
JAN-APR
2012
2013
2014
TOTAL
Unknown
30
20
50
*Based upon file validation tracking
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Submissions by Product Type
Type
ADaM
SDTM
TOTAL
Vaccines
1
2
3
Blood
Derivatives
17
30
47
Cell/Tissue/Gene
Therapy
0
0
0
*Allergenic products are exempt
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Standards Adoption and Use:
Top 7 Errors
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
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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 Meeting
April 25, 2014
Data Standards Lifecycle Phases
Engage SDO: If
standard no longer
meets CBER
requirements,
propose major
revision or new
standards project
Performance
Monitoring: Ensure
standard continues to
meet business needs
and adjust to changing
environment
Operations and
Maintenance: Leverage
CBER CCB process to
maintain systems for
continued standards
use
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
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
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CBER DSS Standards Portfolio
Data standards categories are used to help determine resource
requirements for each project:
Standards Type
Data Exchange
Definition
Example
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
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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
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