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 FDA 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 3 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 Collaboration s 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 4 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 5 CBER DSS Governance Relationships CBER 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 6 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 Subcommittee CBER CDIS C
Development & Testing CDISC Data Submission XML Pilot Post Market Submissions Implementatio n Adoption eVAERS / ICSR (IT, Regulatory Policy, Business Process) ICH E2B(R3) IDMP Adoption (for ICSR) ISO IDMP Implementatio n 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 8 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 eCT D eSubs & FDASIA eStudy Data Study Data Standards Technical Guide
eSRR Reviewer/Industry Training and Support JReview Dataset s loading request s Training CBER Website, SOPs Performance monitoring helps to identify problems and issues from the review community Process improvements help to address regulatory requirements for data 9 reuse and linking, e.g., pre and post market safety reports Center Informatics Monitoring Projects Data Standards Monitoring Activity External SDO Work CDISC CDAS H
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 10 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 11 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 12
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 13 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 14 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 15 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 16
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 18 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 19 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 CBERs 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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