MDR requirements - draft 0.3

MDR requirements - draft 0.3

Implementation of CDISC standards supported by global mapping process and metadata library (Case Study) Dimitri Kutsenko (Entimo AG) Global teams Different time zones North America Europe Asia Africa Latin America Australia

Central Front Office" Hub Supporting Hubs 10-Oct-2011 2 Outline Past situation Challenges of mapping to CDISC SDTM with global, virtual teams Implementation approach Global process Enabling environment with meta library Results | Conclusions 10-Oct-2011

Cost of Change Curve Early QC Paradigm QC Tasks 10-Oct-2011 Mapping to CDISC SDTM with global, virtual teams Past challenges (1/2) Teams and team members distributed globally Multiple tasks involved Creating specifications Programming SDTM datasets Technical review of specifications and programs Functional review of the datasets

Working differently No consistent approach in creating specifications and programs (examples: data transfer, define) Re-usability was difficult to achieve Strict time lines 10-Oct-2011 Mapping to CDISC SDTM with global, virtual teams Past challenges (2/2) Studies: New and legacy Coming from different systems Source database extracts available in different

structures Have to be made ready for CDISC submissions Metadata are often limited/not available No re-usable objects available Standards: Many levels and versions simultaneously Multiple customer specific standard enhancements Growing complexity of standards 10-Oct-2011 Mapping to CDISC SDTM with global, virtual teams Efficient generation of SDTM compliant data sets requires establishment of new

processes!!! 10-Oct-2011 Approach: Global process for global, virtual teams Working Worldwide Goals (1/2) Consistency and re-usability of standards (incl. sponsor-specific) Definition of a global process: Start from existing local best practices - Example: Set-up for blinded vs. unblinded programmers, technical programming code review Create common use cases - Example: Creating consistent test cases for quality and

efficiency 10-Oct-2011 Approach: Global process for global, virtual teams Working Worldwide Goals (2/2) Definition of a global process: Streamline processes - Create process maps for all data conversion scenarios Use advantages of a global player - Global teams to follow the streamlined process - Convert data consistently across the globe Look for productive tool to support processes - All components available in one central location to

easier implement best practices - Global accessibility of the enabling environment - 21 CFR Part 11 compliant and validated - Flexible and scalable 10-Oct-2011 Approach: Global process for global, virtual teams Mapping Process (1/2) Generic View Face-lifting: Designed to allow for task splitting Intellectual mapping - Determine how to map trial data into SDTM - Detect and create re-usable mapping templates Program generation - Automate generation of mapping programs Program execution

- Create environment for controlled and traceable program execution (SCE) QC - Multi-stage QC 10-Oct-2011 Approach: Global process for global, virtual teams Mapping Process (2/2) Generic View Roles Librarian SDTM Mapper Reviewer(s) IT 10-Oct-2011

Mapping Process: Maintain Library (1) Library: Common global library Customer specific models Supports of different standard types: Terminology, codelists, format catalogs Study folder structures Standard macros, mappings Central lab specifications Sponsor guidelines

Standards governance: Versioned storage of parallel versions Controlled access via roles 10-Oct-2011 Mapping Process: Maintain Library (2) - Librarian Role Types: Data Standards librarian SDTM Mapping librarian TLF Shells librarian Tasks: Maintain information model and logical data models Develop mapping templates and standard algorithms Develop standard codelists, macros Maintain consistency of variables (content, process)

Prepare recommendations for standards governance 10-Oct-2011 Mapping Process: Maintain Library (3) Requests are submitted via standard electronic request form (including links to spec and code) User group evaluates requests Decision is communicated to requester If decided, object is created/amended After documented QC by independent librarian, new standard is released

10-Oct-2011 Metametadata Concept Metametadata Rules for metadata definitions Define content/column structure for domain definitions Define values for column content to support checks Contain check rules for domain definitions Rule examples: CDISC type character, mandatory, {value space} attribute sequence integer, unique, starts with 1 10-Oct-2011 Mapping Process: Define Dataset Structures Define Dataset Structures:

Use SDTM domain templates to create target structures Optional: Derive source structures from datasets Import codelists and create format catalogs Metadata check rules apply! 10-Oct-2011 Mapping Process: Define Mapping Intellectual mapping - Define mapping specification Define mapping with entimICE for each domain Standards exploited for:

Dataset structures Standard conversion algorithms Pre- / post-processing tasks Quality means: Consistency checks in the mapping definition Interactive review mode Source side data in the mapping program 10-Oct-2011 Mapping Process: Generate and Run Mapping Program Mapping programs are generated from mapping definitions Programs contain parameters for datasets Programs are executed with set parameters

Logs are reviewed SDTM check program is executed with standard and additional checks Mapping program is marked as ready for 1st QC step 10-Oct-2011 Mapping Process: Quality Control 3-stage QC: Internal review Functional QC Technical QC QC steps includes: Logical checks (e.g. dates, visits) Runs of SDTM check program

Assessment of pre-defined check criteria (e-forms) 10-Oct-2011 Mapping Process: Generate Define Documents Necessary elements are created (value level metadata, algorithms) Domain metadata are reused to create define (used for mapping definition) All SDTM domains are linked to elements

CRF annotation are scanned for pages Define is generated QC of define documentation is done workflow-based 10-Oct-2011 Archive Study Requested study is exported as hierarchy with all reports and objects Access rights are removed Requester is notified 10-Oct-2011 Data Standards How does it fit together Mapping

Library Protocol Design CDASH Information Model (consistent definition of common information across system (e.g. site id, user id) + MASTER/SLAVE SDTM Rave INFORM

DataLabs Standard MedDRA LOINC Standard Data Elements & Coding LIBRARY & Conventions Standard Standard eCRF eCRF LIBRARY eCRF

LIBRARY LIBRARY SDTM Mapping eCRF data Standard ADaM Source: Priya Gopal, PhUSE SDE Boston 2010 TLF data sets TLF shell LIBRARY

10-Oct-2011 Define.xml entimICE SDTM in XPT ADAM Results Teams work consistently across the globe Process is defined and broken down into smaller tasks Clear task responsibilities defined

Same look and feel Easier training of new colleagues Tasks shared between remote team members Re-use of standard elements Growing library saves time, increases quality Efficiency in the data conversion process Continuous QC with multiple QC stops Secures outcome quality 10-Oct-2011 Conclusions Providing SDTM data transfers to sponsors is

becoming habitual task Processes and tools to support this task need to be in place QC has crucial importance (the earlier, the better!) Flexibility required to support ongoing development and changes Vision: Standard eCRF plus a well-filled metadata store make life much easier 10-Oct-2011 END Many thanks for your attention! Questions? VISION STARTS NOW!

10-Oct-2011

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