data centric sdlc for automated clinical data …title data centric sdlc for automated clinical data...
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![Page 1: Data centric SDLC for automated clinical data …Title Data centric SDLC for automated clinical data development v13 - after phuse Author Kevin Lee Created Date 10/16/2015 10:11:17](https://reader034.vdocuments.mx/reader034/viewer/2022042416/5f317bd8e1bb78354d58a6e1/html5/thumbnails/1.jpg)
© COPYRIGHT 2015 MARKLOGIC CORPORATION. ALL RIGHTS RESERVED.
Data-centric System Development Life Cycle (SDLC) for Automated Clinical Data Development SystemKevin Lee, MarkLogic
![Page 2: Data centric SDLC for automated clinical data …Title Data centric SDLC for automated clinical data development v13 - after phuse Author Kevin Lee Created Date 10/16/2015 10:11:17](https://reader034.vdocuments.mx/reader034/viewer/2022042416/5f317bd8e1bb78354d58a6e1/html5/thumbnails/2.jpg)
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Agenda1. Data-centric thinking2. Birth of Automated Clinical Data Development System(ACDDS)3. Introduction of System Development Life Cycle (SDLC) 4. SDLC for Automated Clinical Data Development System5. Data-centric SDLC6. Consideration of ACDDS7. Conclusion8. Questions
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1. World largest transportation company?
Quiz 1?
On December, 2015, there are about 162,037 “active drivers” completed at least four or more trips for the service. The number of new drivers signing up has doubled every six months for the past two years.?
According to 2012 “Bureau of Labor Statistics, 233,00 taxi drivers.
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2. World largest accommodation provider?
Quiz 2?
– Inc.'s 2014 Company of the Year– In 2014 alone, 10 millions used airbnb. This year, their website surpassed 800,000 listings worldwide, which means they now offer more lodging than Hilton Worldwide or InterContinental Hotels Group or any other hotel chain in the world.
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§ Data
§ Interface/system to process data and exchange information
Common characteristics of exponential organization
Exponential & Scalable Growth
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Increase in Clinical Trials (clinicaltrials.gov)
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Automated Clinical Data Development System
CDASH SDTM ADaM
How to apply this data-centric thinking in clinical trial?
- End to End Clinical Data Development and Management
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Typical system
System
Database
–Process automation (e.g., Airport auto Check In)
–Data used in system resides inside of system.–The structure of data does not change unless process changes.–Process dictates data structure in database.
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SDLC (System Development Life Cycle)
Requirements
Analysis
Design
Build
Test
Implementation
A conceptual model used in project management that describes the stages involved in an information system development project.
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Shift of SDLC perspectives
Typical, process automating System
• SDLC• Automates process• Process dictates data• Data stays inside of system• Interaction b/w users and interface
Clinical Data Development System
• Data-centric SDLC• Automates data development• Data dictates process• Data coming into system and leaving the system• Transformation from source to target data
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Data-centric SDLC?
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Data-centric SDLC: Requirements§ User Requirements– What data users want to develop– Ex. Users want to create SDTM DM data set
§ Functional requirement– How System creates data– Ex. System will create SDTM DM data set without errors and within 10
seconds
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Data-centric SDLC: Analysis§ Business Requirement Analysis§ Target Data Requirement Analysis
– Data format, structures and model– Data Quality
§ Source Data Requirement Analysis – Data Discovery
– Origin, data format, structures and model– Data Profile
– Understanding contents of data– Data Quality
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Data-centric SDLC: Design § System Design§ Data Design (Source, Intermediate, Target)– Data Architecture/Modeling – Database Design
SystemSource Data
Target Data
Intermediate Data
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Data-centric SDLC: Build§ ACDDS– Flexible codes for post-development
§ Data compliance check system
ACDDSSource Data
Target Data
Intermediate Data
Data Compliance(Structural and contents) Check System
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Data-centric SDLC: Test
§ System Testing: Unit Test, Integration Test, System Test and User Acceptance Test
§ Data Testing of target data– Data Profiles
– Any data quality issues – Data contents follow certain terminologies.
– Data Compliances –correct data structures
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Data-centric SDLC: Post-development
§ New source data§ Data model change in target data
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Data-centric SDLC – collaboration between IT and Biometric
• IT department – expertise on SDLC• Biometric department – expertise on Data
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Consideration of Automated Clinical Data Development System
(ACDDS)
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Consideration of ACDDS - continued
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Consideration of ACDDS - continued
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Metadata-driven ACDDS
ACDDSSource Data
Target Data
Intermediate Data
Metadata
• Machine-readable structural format of source and target data• Machine-readable transformation from source to target data
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Data-centric system
§ Data > System
§ Data dictates system – build system for the data
§ Maybe no data transformation – Data ingest into system without transformation– Schema-agonistic data warehouse
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Conclusion§ Think differently– Data-centric thinking?
§ Do differently– Data-centric SDLC?
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