Data Centric SDLC For Automated Clinical Data Development V13 - After Phuse

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Data- centric  System  Development  Life  Cycle  (SDLC) for  Automated  Clinical  Data  Development  System Kevin  Lee,  MarkLogic  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Agenda 1. 2. 3. 4. 5. 6. 7. 8. SLIDE:  2 Data- centric  thinking Birth  of  Automated  Clinical  Data  Development  System(ACDDS) Introduction  of  System  Development  Life  Cycle  (SDLC) SDLC  for  Automated  Clinical  Data  Development  System Data- centric  SDLC Consideration  of  ACDDS Conclusion Questions  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Quiz  1? 1. World  largest  transportation  company? 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. SLIDE:  3  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Quiz  2? 2. World  largest  accommodation  provider? – 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. SLIDE:  4  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Common  characteristics  of  exponential  organization Exponential &  Scalable Growth SLIDE:  5 § Data § Interface/system  to  process  data  and exchange  information  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Increase  in  Clinical  Trials  (clinicaltrials.gov) SLIDE:  6  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

How  to  apply  this  data- centric  thinking  in  clinical  trial? - End  to  End  Clinical  Data  Development  and  Management Automated Clinical  Data Development System CDASH SLIDE:  7 SDTM ADaM  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Typical  system –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. System Database –Process  dictates  data  structure  in database. SLIDE:  8  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

SDLC  (System  Development  Life  Cycle) A  conceptual  model used  in  project management  that describes  the  stages involved  in  an information  system development  project. Requirements Analysis Design Build Test Implementation SLIDE:  9  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

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 SLIDE:  10 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  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC? SLIDE:  11  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC:  Requirements User  Requirements § – What  data  users  want  to  develop – Ex.  Users  want  to  create  SDTM  DM  data  set Functional  requirement § SLIDE:  12 – How  System  creates  data – Ex.  System  will  create  SDTM  DM  data  set  without  errors  and  within  10 seconds  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC:  Analysis Business  Requirement  Analysis Target  Data  Requirement  Analysis § § – Data  format,  structures  and  model – Data  Quality Source  Data  Requirement  Analysis § SLIDE:  13 – Data  Discovery – Origin,  data  format,  structures  and  model – Data  Profile – Understanding  contents  of  data – Data  Quality  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC:  Design System  Design Data  Design  (Source,  Intermediate,  Target) § § – Data  Architecture/Modeling – Database  Design System Source Data SLIDE:  14 Intermediate  Data Target Data  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC:  Build ACDDS § – § Flexible   codes  for  post- development Data  compliance  check  system ACDDS Source Data Target Data Intermediate  Data Data  Compliance(Structural  and contents) Check  System SLIDE:  15  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

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. – – SLIDE:  16 Data  Compliances  –correct  data  structures  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC:  Post- development § § SLIDE:  17 New  source  data Data  model  change  in  target  data  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  SDLC  – collaboration  between  IT  and  Biometric IT  department  – expertise  on  SDLC Biometric  department  – expertise  on  Data SLIDE:  18  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Consideration  of  Automated  Clinical  Data  Development  System (ACDDS) SLIDE:  19  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Consideration  of  ACDDS  - continued SLIDE:  20  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Consideration  of  ACDDS  - continued SLIDE:  21  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Metadata- driven  ACDDS Machine- readable  structural  format  of  source  and  target  data Machine- readable  transformation  from  source  to  target  data Metadata ACDDS Source Data SLIDE:  22 Intermediate  Data Target Data  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data- centric  system § Data    System § Data  dictates  system – Maybe  no  data  transformation § SLIDE:  23 build  system  for  the  data – Data  ingest  into  system  without  transformation – Schema- agonistic   data  warehouse  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Conclusion Think  differently § – Do  differently § – SLIDE:  24 Data- centric  thinking? Data- centric  SDLC?  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Contact  Information  and  Questions Email  address  :  kevin.lee@marklogic.com Linkedin Profile  : www.linkedin.com/in/HelloKevinLee/ Tweet  :  @HelloKevinLee Slide  share  : http://www.slideshare.net/KevinLee56 Blogs  :  HiKevinLee.tumblr.com SLIDE:  25  COPYRIGHT   2015   MARKLOGIC   CORPORATION.   ALL  RIGHTS   RESERVED.

Data centric SDLC for automated clinical data development v13 - after phuse Author: Kevin Lee Created Date: 10/16/2015 10:11:17 PM .

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