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Industry Standards for the Electronic Submission of Data to the FDA - PowerPoint PPT Presentation
Industry Standards for the Electronic Submission of Data to the FDA
Models are intended to help fda reviewers view data and replicate analyses, ... provided models and sample data scenarios to fda to aid in preparation of a new ... – powerpoint ppt presentation.
- Michael A. Walega
- Biometrics Quality Technical Systems
- Why Data Standards
- Overview of Clinical Data Interchange Standards Consortium (CDISC)
- CDISC Working Teams
- Regulatory Implications
- What Standards to Implement?
- Weve got questions...
- Within an organization
- Improve consistency and efficiency
- Enhance critical timings
- Concentrate on scientific nature of data rather than structure of data
- Between organizations
- Leverage synergies
- Sponsor-to-sponsor, vendor-to-sponsor, etc.
- Sponsor-to-Regulatory Agency
- Develop standard data models that support the scientific nature of clinical research
- Flexible, easily interpreted regulatory submissions
- Model quality and integrity, independent of implementation strategy and platform
- Global, multidisciplinary, cross-functional teams
- Maximum sharing of information with other groups
- Educational programs
- Not promote any individual vendor or organization
- Data Sources
- Laboratories
- Organizations
- Development
- Discovery Data
- Operational
- Audit Trail
- Submission Data
- CRT Datasets
- Analysis datasets
- To support the CDISC XML Document Type Definition (DTD) for operational data interchange and archiving
- To stimulate adoption of the model by industry stakeholders
- To expand the usability, scope and applicability of the model
- Expand model support for lab data
- Address known issues with Version 1.0
- Support testing and adoption of the model, including a proof of concept Connect-a-thon at 2001 DIA Annual Meeting
- Support for data clarification and queries
- Define migration plans to XML Schemas
- Expand protocol definition capabilities
- Increased interoperability with HL7, etc.
- Extend model to support real-time data
- Increased support for multimedia data types
- Accomplishments
- v1.0 examples available at CDISC website
- Clinical data models and study metadata are close to full functionality
- Expect v1.1 summer 2001, v2.0 2Q2002
- To define requirements for expanding the ODM XML DTD to improve laboratory data interchange
- To test the CDISC data model with complex real laboratory data to assure its functionality
- To explore other opportunities to standardize aspects of laboratory data processing
- Propose additions and revisions to the ODM Group for the XML data model to optimally support laboratory data
- Circulate the revised ODM data model for public review and comment by laboratory stakeholders
- Develop a testing plan for the data model
- Evaluate the data model with multiple testing scenarios involving real data
- Define standard metadata models that describe the structure, usage, content and attributes of Case Report Tabulations (CRT) and other data sets submitted to Regulatory Authorities
- Models are intended to help FDA reviewers view data and replicate analyses, tables, graphs, and listings without requiring complex programming or data transformations.
- Overall Strategy
- Follow lead of FDA Submission Guidelines
- Regulatory Reviewer(s) primary customer(s)
- Define basic safety metadata standards
- Guide data set organization -- not rigid structures
- 80 of domains and 80 of variables
- Use representative examples, not hard rules
- Allow flexibility for science and sponsor differences
- Begin with 12 safety domains identified in FDA e-submissions guidance
- Post standards openly and encourage ongoing input by all
- Metadata Strategy
- Organize data sets in folders follow FDA Guidelines
- Define structure of analysis for each data set
- Patient-level, Visit-level, Incident-level, Item-level
- Add common variables to all data sets
- Core, selection, etc.
- Classify variables by
- Origin (where its from) Source, Derived, Mapped
- Role (how it s used) - Key, Selection, Review, Support
- Attributes (what it means) - Labels, Types, and Codes
- Allow sufficient latitude for adding other variables and domains where scientifically appropriate
- Documentation Strategy
- Describe the information needed to understand the domain
- Clarify and address anticipated questions
- Provide philosophy behind the domain structure
- Document decisions and use as training material
- Rationale and criteria for the decisions
- Document variables that could collect, code or predefined
- Recommend standard vocabularies, codes dictionaries and other conventions for representing data
- Revise and support the 12 safety domain models
- Publish sample data scenarios as examples for applying the models
- Publish additional documentation on the assumptions and use of the model
- Define new models for PK Data
- Define new domain models for additional safety and efficacy data sets
- Increase interoperability with the ODM XML Model
- Published v1.0 of 12 safety domain metadata models in October 2000
- Publish v1.1 of safety domain metadata models in July 2001
- Completed sample data scenarios
- Provided models and sample data scenarios to FDA to aid in preparation of a new CRT Guidance
- Defined content for additional model documentation
- Supported analysis of computer-readable metadata for FDA
- Developed to accommodate planned, actual, elapsed time collection
- Each parameter has a separate variable name
- Could be expanded by adding additional variables
- Domain name VITALS
- Description Vital Signs
- Location VITALS.XPT
- Structure 1 Record per subject (per position/qualifier)
- Purpose CRT
- Keys USUBJID, VISIT (, POSITION)
- Sort Consistent with structure
- Expand model details
- Variable definitions
- Vocabularies, Code Lists and Dictionaries
- Models for other domains
- Study Domain, Investigator/Site Domain
- Social History
- QOL, therapeutic efficacy data, Hospital Admission/Discharge/Pharmacoeconomics
- Connections/Interoperability with ODM
- Future technical formats (e.g., XML Metadata)
- To provide metadata models (One PROC Away) and examples of analysis data sets that are used to generate the statistical results for a regulatory submission
- Limit scope to examples for primary and secondary efficacy analyses
- Provide samples for different analysis types
- Develop documentation for analysis datasets
- Developed draft strawman analysis dataset for change from baseline for SDS labs model
- Developed draft principles statement
- Held in February 2001
- Meeting Goals
- Increase FDA understanding of CDISC models
- Achieve buy-in and feedback on CDISC models
- Achieve buy-in for incremental approach
- Identify requirements for incorporating CDISC models into rolling FDA guidelines
- Discuss plans for moving forward
- How CDISC can help FDA raise internal awareness of standards
- Joint FDA/CDISC meeting planned for late summer 2001
- Next steps for guidance documents
- eXtensible Markup Language
- Standardized method for rendering complex structured metadata/data in text format
- Sponsored by World Wide Web Consortium
- Nearly universally adapted by internet community and software industry for data exchange
- Non-proprietary ASCII format
- Extensive support by vendors
- Good match to hierarchical patient data
- Adaptable to data warehousing
- XML example
- PatientId 123456789
- EnrollDate 2001Jan01
- Gender Male
- PatientInits HAL
- DateOfBirth 2000Jan01
- RandomDate 2001Jan02
- FDA Involvement
- Liaisons from electronic submissions groups within CBER / CDER actively involved
- Safety domains internally reviewed
- Guidance re submission of CRT data has been drafted internal review ongoing
- ICH Involvement
- ICH liaisons have been involved
- Data standardization not addressed till 2004
- Supports CDISC initiatives
- Submissions to Regulatory Agencies
- North America
- Metadata / Data
- CBER/CDER ready for CDISC SDS submission
- Volunteers???
- Impact in early 2002 (SDS), late 2002 (ADaM)
- Rest of World (ICH)
- Data normally not required as part of submission
- No formal guidance re data standards till 2004 (or later?)
- Will follow FDA (CDISC) lead
- Regulatory Submissions Data
- Safety / Background Characteristics
- 12 domains identified in FDA NDA e-submissions guidance
- Occur in majority of Phase I-III clinical trials
- Well-defined
- Initially via FDA guidance
- More completely through CDISC SDS model
- Other data domains (Efficacy, QOL, Diary)
- Analysis data
- Highly variable
- Follows development of regulatory submissions data standards
- Safety / Background Characteristics will be first (CDISC ADaM)
- Data standards will soon be a reality
- e-Sub Guidance to address standards for submission of data to FDA
- CDISC data models offer an excellent baseline
- CDISC website www.cdisc.org
- ODM and SDM Working Groups Wayne Kubick (wkubick_at_enteract.com)
- ADaM Team Art Devault (adevault_at_pcyc.com)
- NJ ASA Presentation michael.walega_at_covance.com
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