1. Data Standards Development FrameworkBackground & Challenges Benefits
Projects follow these process steps as relevant to project scope.
Define
Scope and
Requirements
Analyze
Alternatives
Test
Standard
Determine
Data Standard
Adoption
Implement
Standard
Industry
Participation in
Standards Testing
(as appropriate)
Standards Development Organization (SDO) Development Process
FDA SME Interaction
1 2 3 5 6 7
Initiation Development Internal
Review
Public
Review
Public
Release
Use an Existing,
Change, or
Develop a Standard
Daily Operations Processes
• Operations
• Administration
• Communication
• Change Control
Data Standards Project(s)
Governance Processes
Ongoing Governance
Unorganized Submission
Review
Data not submitted in a standardized
format using distinct data rules impedes
the FDA regulatory reviewers’
aggregation and review of data.
!
Inefficient Submissions
Analysis
The lack of standardized data and
preferred submission format affects the
FDA regulatory reviewers’ critical analysis
of the regulatory submissions. FDA
conclusions on regulatory submissions are
driven by strict mandated timelines.
!
Enhanced Data Quality
and Consistency
Project Managers follow a repeatable,
consistent, and organized approach to
their data standard projects, identifying,
defining, and implementing drug
submission data standards for reliable
data in a predictable format.
Improved Timeliness
of Review
Data standards allow automation of
analyses and reduction of the number of
information requests from reviewers to the
pharmaceutical companies and drug
manufacturers during the review process.
Increased Effectiveness
of Review
Data standards impact a regulatory
reviewer’s ability to effectively integrate
data and use analytical tools to ensure
drugs are safe and effective.
Data Standards Development Framework:
A Framework for Developing and Implementing Data Standards
for Drug Regulatory Reviewers at the U.S. Food and Drug Administration
Drug Data Inconsistencies
Regulatory submissions in multiple formats
provide unpredictable data. Paper
submissions are increasingly less
sustainable due to the physical space
requirements to store the large volume of
paper received.
FDA receives regulatory submissions, in both electronic
and paper formats, from drug companies applying for
FDA approval of new pharmaceuticals for marketing in
the United States. Effective December 2016, submissions
not submitted electronically, in FDA approved format,
may not be filed or received, unless exempted from the
electronic submission requirements.
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www.drtstrategies.com
Approach Solution
Meetings held with FDA Project
Managers and Research and
Public Health Analysts resulted in
the development of Standard
Operating Procedures (SOPs)
and a Manual of Policy and
Procedure (MAPP) for a
uniformed approach to data
standards projects across the
Center.
The FDA Center for Drug
Evaluation and Research
(CDER) established a
governance structure and
applied the discipline and
rigor of PMBOK-based project
management processes to
data standards projects.
4 External Processes