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Integrating Trial Data Processes Across Functional Areas using Electronic Data Capture (EDC) Technology
 

Integrating Trial Data Processes Across Functional Areas using Electronic Data Capture (EDC) Technology

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    Integrating Trial Data Processes Across Functional Areas using Electronic Data Capture (EDC) Technology Integrating Trial Data Processes Across Functional Areas using Electronic Data Capture (EDC) Technology Document Transcript

    •      Integrating  Trial        Data  Processes      Across  Functional     Authors:  Areas  using   Bill  Gluck,  PhD   DATATRAK,  VP  of  Clinical  and  Electronic  Data   Consulting  Services    Capture  (EDC)   Lorraine  D.  Ellis,  MS,  MBA   Research  Dynamics  Consulting  Technology   Group,  Ltd.,  CEO               2011  
    • 2  of  8    Table of Contents1   Introduction  ...........................................................................................................................................  3  2   Process  Workflow  Changes  ...................................................................................................................  3   2.1   Data  Collection  ................................................................................................................................  4   2.2   Recording  Data  ................................................................................................................................  5   2.3   Monitoring  ......................................................................................................................................  5   2.4   Cleaning  Data  ..................................................................................................................................  6  3   Summary  Overview  of  Process  Changes  and  Benefits  –  Focus  on  Clinical  Ops  and  CDM  Interactions  .  7   3.1   Investigator  Sites  Benefits   ...............................................................................................................  7   3.2   Clinical  and  Monitor  Group  Benefits  ...............................................................................................  7   3.3   Data  Management  Benefits  ............................................................................................................  7   3.4   Statistical  Benefits  ...........................................................................................................................  8  4   Conclusion  .............................................................................................................................................  8                         Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology      
    • 3  of  8    1 Introduction  One  common  theme  in  the  pharmaceutical,  biotechnology  and  medical  device  industry  is  the  constant  pressure  to  accelerate  development  of  drugs,  biologics  and  products  to  market.  Improvements  usually  tend  to  focus  on  one  aspect  of  the  development  workflow  at  a  time.  One  of  the  processes  that  is  the  most  time  and  effort  intensive  is  data  collection  and  management.  Clinical  data  workflows  have  traditionally  been  tweaked  especially  with  the  growing  acceptance  of  new  technology  and  more  contemporary  enterprise  eclinical  applications  (those  applications  that  include  clinical  trial  management  systems  (CTMS),  electronic  data  capture  (EDC),  randomization  and  drug  supply,  etc.).  Today  many  companies  are  viewing  procedures  not  only  within  but  across  functional  areas  as  a  necessity  to  streamline  data  flow  and  the  development  process.  This  white  paper  will  describe  some  of  the  process  re-­‐engineering,  role  modification  or  definition,  enhanced  communication  and  project  coordination  improvements  needed  to  implement  the  use  of  an  EDC  application  across  the  functional  areas  of  clinical  monitoring,  project  management,  Investigator  sites,  and  clinical  data  management  (CDM)  so  companies  can  maximize  the  benefits  of  today’s  technology.    Electronic  Data  Capture  technology  has  only  been  practiced  widely  in  the  industry  for  the  past  5-­‐to-­‐10  years  even  though  it  was  introduced  more  than  25-­‐years  ago.  Early  EDC  applications  were  more  remote  data  entry  stations  that  served  only  to  move  the  data  entry  process  to  the  sites;  there  were  not  many  procedural  or  process  changes.  Also,  early  EDC  software  lacked  the  extensive  functionality  to  evaluate  the  quality  of  the  data  that  are  found  in  today’s  systems.  As  the  EDC  application  matured,  it  became  evident  that  process,  role  and  procedural  changes  were  necessary  in  order  to  realize  the  full  benefits  of  the  technology.  These  changes  were  (are)  not  limited  to  changes  within  the  management  of  data  but  also  across  the  entire  clinical  trial  process.    2 Process Workflow Changes  Changing  from  a  paper-­‐based  data  collection  system  to  an  electronic-­‐based  data  collection  method  requires  changes  in  the  approach  to  data  collection,  processing,  and  management.  Processes  in  an  EDC  environment  must  be  re-­‐engineered  to  optimize  all  the  benefits  of  the  technology.  For  example,  roles  and  responsibilities  of  the  three  key  functional  groups  within  a  clinical  study:  the  Investigator  sites,  Clinical  Monitors  and  Clinical  Data  Managers  need  to  be  re-­‐defined  to  realize  the  benefits  of  the  technology.  Investigator  sites,  for  example,  no  longer  complete  paper  case  report  forms  as  they  enter  the  required  data  directly  into  the  EDC  application.  Monitors  now  modify  their  monitoring  procedures  to  review  data  before  they  go  to  the  site  so  they  can  be  more  efficient  in  managing  site  trial  performance  and  reviewing  data  against  source  documentation.  Clinical  data  management  too  must  adjust  internal  processes  and  procedures  as  there  are  many  differences  between  paper-­‐based  approaches  to  collecting  data  versus  an  EDC  approach.  The  “flow”  of  the  data  must  be  evaluated  and  roles  and  responsibilities  of  each  task  adjusted.  For  example,  CDM  in  a  paper-­‐based  environment  would  be  responsible                       Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology      
    • 4  of  8    for  the  assignment  and  resolution  of  data  queries,  whereas  in  an  EDC  application  some  of  the  assignment  and  resolution  of  queries  may  be  distributed  across  CDM  and  the  clinical  monitoring  group.  To  discuss  the  revised  workflow  of  data  using  EDC,  we  have  broken  the  data  process  into  four  key  elements:    collection,  recording,  monitoring  and  cleaning.    2.1 Data Collection  The  data  collection  process  using  EDC  is  considerably  different  than  paper-­‐based  processes.  In  this  context,  data  collection  is  defined  as  the  design  of  the  eCRFs  and  the  underlying  clinical  database  files  during  the  start-­‐up  portion  of  the  study.  The  EDC  application  design  is  critical  as  it  needs  to  be  completed  in  advance  of  the  first  patient  being  screened  into  a  study;  it  must  conform  and  follow  the  study  protocol.  Since  the  Investigator  site  personnel  enter  data  into  the  eCRFS,  the  eCRFS  must  be  designed  for  the  workflow  of  the  Investigator  site  as  it  conducts  the  protocol  and  records  the  data.  The  EDC  application  should  be  designed  in  such  a  manner  to  facilitate  data  exports  to  meet  the  needs  of  the  staff  performing  the  analysis.      One  benefit  of  a  well-­‐designed  EDC  application  is  improved  protocol  compliance.  The  flow  of  the  EDC  application  from  one  eCRF  screen  to  another  should  follow  the  flow  of  the  study  protocol.  Thus,  site  coordinators  are  guided  through  the  study  not  only  by  the  protocol  itself  but  through  the  screens  of  the  application  as  they  are  completed.  The  eCRFs  should  contain  edit  checks  that  alert  the  Investigator  site  when  they  are  in  conflict  with  the  protocol  such  as  entering  an  ineligible  patient  or  forgetting  to  complete  a  procedure  and  record  the  results.    The  design  of  an  EDC  application  and  eCRFs  should  include  all  functional  groups  involved  in  a  clinical  study.  This  involvement  will  require  procedural  changes  that  are  different  from  paper-­‐based  studies  in  how  the  study  is  planned  and  initiated.  Not  only  does  the  team  need  to  identify  what  data  are  required  for  the  study  via  reviews  of  the  protocol  but  all  edit  checks  must  be  defined  and  programmed  into  the  application  during  the  study  design,  not  after  the  study  has  begun.  Clinical  staff  should  provide  input  on  the  flow  of  the  eCRF  to  match  clinical  procedures  and  whether  input  is  mandatory  or  voluntary.  Field  parameters,  labels  and  ranges  can  also  be  provided  by  the  clinical  staff  to  enhance  protocol  compliance.  Input  from  the  biostatisticians  is  essential  as  critical  data  fields  must  be  identified  and  included  in  the  design  specifications  and  programming.      Because  the  design  of  the  eCRFs  and  the  database  occurs  before  the  study  starts  and  is  a  team  effort,  the  clinical  staff  must  “test  drive”  the  draft  eCRFs  with  an  Investigator  site  to  ensure  that  the  questions  are  worded  appropriately,  the  field  size  and  parameters  are  suitable  for  the  data  entry,  and  the  order  of  the  questions  follows  the  protocol  procedures  for  easier  data  entry.  Because  of  the  abilities  of  EDC  to  prevent  inappropriate  questions  from  being  answered,  the  Clinical  group  also  contributes  to  the  decisions  of  when  questions,  such  as  pregnancy  tests,  should  be  answered.                         Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology      
    • 5  of  8    2.2 Recording Data  One  clearly  defined  difference  in  an  EDC  system  from  the  traditional  paper-­‐based  workflow  is  the  need  for  Investigator  site  staff  to  enter  their  own  patient  data  into  the  application.  EDC  systems  must  be  designed  to  facilitate  entry,  easy  to  understand  and  easy  to  navigate,  as  site  staff  do  not  have  the  time  to  learn  or  use  an  intricate  system.  An  advantage  of  most  EDC  systems  is  the  functionality  to  alert  the  site  staff  when  entries  are  entered  erroneously  and  easily  allows  them  to  revise  the  entry  without  generating  a  time-­‐consuming  query.  This  process,  only  available  when  using  EDC,  eliminates  many  of  the  queries  generated  when  paper  CRFS  are  used.  The  EDC  system  speeds  the  generation,  resolution  and  tracking  of  queries  by  providing  the  site  staff    the  ability  to  easily  make  data  corrections  online  instead  of  searching  for  and  manually  updating  paper  eCRFs.  The  process  of  documenting  protocol  compliance  also  becomes  easier  with  EDC,  as  well-­‐designed  eCRFs  prevent  the  entry  of  data  that  would  be  a  protocol  violation.  The  system  alerts  the  site  staff  to  improve  protocol  compliance  and  the  entry  of  protocol  compliant  data.    The  use  of  field  sizes,  edit  parameters  and  data  ranges  embedded  in  the  eCRFs  also  improves  the  recording  of  data  by  the  Investigator  site  staff,  as  these  items  provide  an  immediate  feedback  mechanism  on  the  accuracy  of  the  data  being  recorded.  Site  personnel  can  update  incorrect  or  incomplete  data  instantly  based  on  this  feedback  and  eliminate  queries.  Both  the  immediate  feedback  and  the  reduction  in  queries  change  the  processes  at  the  site  and  increase  site  efficiency.    2.3 Monitoring  The  monitoring  process  of  ensuring  data  quality  and  protocol  compliance  should  be  re-­‐engineered  to  obtain  the  benefits  of  an  EDC  system.  Instead  of  only  viewing  the  data  and  protocol  results  every  4-­‐to-­‐6  weeks  during  an  on-­‐site  monitoring  visit,  the  Monitor  or  other  staff  member  can  review  the  data  in  real  time  as  it  is  entered  by  the  site.  As  data  is  reviewed  and  monitored  in  real  time,  errors  in  data  entry  by  the  site  can  be  identified  and  retraining  can  be  performed  to  prevent  further  and  often  more  costly  errors.  Also,  errors  in  eCRF  design  can  also  be  detected  and  changed  earlier  in  the  process  to  prevent  erroneous  data  from  being  recorded.  After  in-­‐house  data  review  through  the  EDC  system,  the  Monitor  is  better  prepared  for  the  on-­‐site  monitoring  visit  by  focusing  on  the  unique  problems  of  that  site  based  on  eCRF  review.  The  Monitor  can  verify  source  documentation  and  use  their  time  to  evaluate  the  site’s  study  conduct  and  provide  remedial  actions  for  any  performance  issues.    Site  performance  evaluation  can  also  be  completed  remotely  using  the  metrics  provided  by  the  EDC  system.  Site  metrics  within  and  across  sites  provide  information  such  as  speed  of  data  entry,  speed  of  query  correction,  number  of  protocol  violations,  etc.  that  document  how  well  the  site  is  conducting  the  study.  These  metrics  can  be  used  to  discuss  performance  with  the  site  and  if  necessary,  implement  a  remedial  action  plan  even  before  the  next  scheduled  on-­‐site  monitoring  visit.                       Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology      
    • 6  of  8    EDC  system  metrics,  such  as  time  to  eCRF  completion,  average  time  from  visit  to  data  entry  and  number  of  queries,  provide  a  ‘window’  into  site  data  issues  in  real  time.  Anomalies  can  then  be  addressed  as  they  occur  instead  of  waiting  4-­‐to-­‐6  weeks  until  the  next  site  visit  to  discover  the  issue,  which  by  now,  has  usually  occurred  multiple  times,  and  then  correct  it.    2.4 Cleaning Data  The  data  query  process  also  needs  to  be  reengineered  when  using  EDC  systems.  Queries  can  be  generated  and  resolved  in  several  ways,  all  of  which  are  much  faster  than  paper-­‐based  systems.  One  major  advantage  is  the  change  in  the  tracking  of  generation  and  resolution  of  queries.  The  EDC  system  keeps  track  of  all  queries  that  are  generated  through  the  system,  so  time  and  resources  are  no  longer  necessary  for  query  tracking.  EDC  system  reports  provide  instant  up-­‐to-­‐date  metrics  on  queries  generated,  resolved,  outstanding  and  the  rate  of  correction  at  each  site.  Query  generation  and  resolution  can  also  be  completed  remotely  by  the  Clinical  group  to  prevent  further  similar  errors  in  data  entry.  The  Monitor  would  then  verify  the  correction  by  source  document  review  when  on  site.  The  Monitor  no  longer  has  to  spend  hours  locating  the  queries,  determining  if  they  have  been  addressed  and  verifying  the  eCRF  corrections.  Once  the  queries  are  resolved,  the  Monitor  just  needs  to  source  document  verify  the  changes.  Through  the  EDC  system,  the  Clinical  staff  also  has  access  to  any  queries  generated  by  Data  Management  and  can  monitor  the  resolution  of  these  queries  as  well.      Data  management  also  leverages  the  query  management  capabilities  of  EDC  systems,  especially  in  the  generation,  issuance,  and  subsequent  resolution  of  manual  queries.  By  adjusting  internal  processes,  Clinical  Data  Management  groups  can  optimize  the  core  functionality  of  EDC  systems  to  fire  automatic  queries  at  entry  in  order  to  reduce  data  entry  errors.  The  primary  focus  of  process  changes  will  affect  manual  queries  issued  by  the  Clinical  Data  Manager.  The  manual  queries  include  those  related  to  cross-­‐form  checks  as  well  as  safety  queries.  The  EDC  system’s  flexibility  provides  additional  benefits  by  creating  process  efficiencies  as  it  is  adapted  to  company’s  current  organizational  structure  and  business  workflows.    Since  all  queries  are  generated,  tracked  and  resolved  in  one  system,  the  data  cleaning  process  becomes  an  integrated  process  between  Clinical  Monitors  and  Data  Managers  which  improves  communication  between  these  groups  and  speeds  the  process.  Current  EDC  applications  also  allow  for  the  assignment  of  permissions  based  upon  company-­‐specific  workflows,  thereby  allowing  roles  and  responsibilities  to  better  align.  This  ability  accelerates  the  process  for  both  departments  as  well  as  the  study  for  faster  database  lock.                           Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology      
    • 7  of  8    3 Summary Overview of Process Changes and Benefits – Focus on Clinical Ops and CDM Interactions  The  use  of  eCRFs  not  only  speeds  the  data  collection  process  but  also  provides  many  benefits  to  all  team  members.        3.1 Investigator Sites Benefits  As  the  concept  of  remote  data  entry  and  subsequent  adoption  of  EDC  applications  became  evident  there  was  push-­‐back  from  Investigator  sites  that  they  would  be  doing  more  work;  however,  there  are  benefits  that  the  sites  gain  through  the  use  of  EDC  applications  that  they  do  not  have  when  using  paper-­‐based  CRF’s.  The  large  reductions  in  the  number  of  queries  and  better  access  to  the  clinical  study  patient  data  are  two  main  benefits  for  the  Investigator  site.  Users  of  EDC  applications  have  documented  reductions  up  to  90%  of  queries,  which  translates  into  huge  time  savings  for  Investigator  site  personnel.  In  addition,  sites  also  have  access  to  patient  data  throughout  the  course  of  the  clinical  study,  which  provides  visibility  to  the  completion  of  clinical  milestones  and  can  lead  to  faster  payments  from  the  sponsoring  studies.    3.2 Clinical and Monitor Group Benefits  Being  able  to  design  the  eCRFs  to  enhance  protocol  compliance  decreases  the  number  and  types  of  protocol  violations  which  results  in  cleaner  data.  The  ability  for  the  clinical  staff  to  participate  in  eCRF  design  and  provide  only  applicable  questions,  set  response  range  limits,  and  prevent  inaccurate  data  saves  time  in  correcting  inaccurate  data.  The  ability  to  review  the  site’s  data  before  the  on-­‐site  monitoring  visit  provides  the  Monitor  insight  into  site  activities  so  they  can  correct  any  issues  in  real  time  instead  of  being  surprised  by  issues  that  are  brought  to  their  attention  when  they  arrive  for  the  next  on-­‐site  visit.    3.3 Data Management Benefits  Another  added  benefit  to  having  the  Investigator  site  enter  data  as  compared  to  having  Clinical  Data  Management  groups  transcribe  and  enter  data  into  Clinical  Data  Management  Systems  (CDMS)  is  that  the  sites  are  much  closer  to  the  data.  The  time  from  entry  to  query  generation  and  resolution  is  compressed  which  results  in  the  availability  of  ‘cleaner’  data  faster  so  clinical  decisions  can  be  made  sooner.  Additionally,  safety  data  are  more  readily  available,  thus  increasing  awareness  of  patient  safety  throughout  the  course  of  clinical  studies.                           Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology      
    • 8  of  8    3.4 Statistical Benefits  In  addition  to  the  data  management  benefits  mentioned  above,  there  are  benefits  ‘downstream’  for  Biostatistics  departments.  These  benefits  include  an  overall  streamlining  of  the  process  as  Biostatistics  are  involved  at  the  front-­‐end  of  the  data  collection  design  so  they  are  well  aware  of  the  data  items  to  be  collected  and  assist  in  the  definition  of  the  back-­‐end  export  data  structure.  This  allows  the  Biostatistical  programmers  to  begin  pre-­‐programming  and  validation  for  the  study  tables,  listings  and  figures  much  earlier  in  the  process,  which  accelerates  the  study  timeline.  Through  the  active  participation  of  all  the  functional  members  of  the  study  team  earlier  in  the  study  process,  especially  Biostatisticians,  data  structures  and  edit  checks  are  better  understood,  thus  promoting  the  reliability  of  data  quality  amongst  the  team.    4 Conclusion  The  use  of  an  EDC  system  to  collect  and  manage  the  data  during  a  clinical  study  is  a  great  advance  in  the  clinical  trial  industry.  However,  the  processes  of  paper-­‐based  CRFs  must  be  evaluated  and  reengineered  to  obtain  maximum  benefit  from  the  EDC  technology.  Just  applying  an  EDC  technology  on  top  of  a  paper-­‐based  collection  process  is  simply  ‘electrifying’  the  paper  process.      In  order  to  optimize  the  process,  a  company  must  review  and  understand  the  current  workflow,  identify  advances  in  technology  and  define  opportunities  where  process  changes  can  benefit  the  overall  organization.  The  introduction  of  EDC  systems  require  a  shift  in  the  roles  and  responsibilities  of  the  Site  Coordinators,  Clinical  Monitors,  Clinical  Data  Managers,  and  Safety  personnel  when  compared  to  the  roles  and  responsibilities  defined  for  personnel  when  using  traditional  paper-­‐based  data  collection  systems.    The  overall  goal  of  integrating  trial  data  processes  across  functional  areas  using  EDC  technology  is  to  streamline  the  company’s  processes;  however,  it  is  imperative  that  companies  also  realize  a  time  savings,  a  heightened  awareness  of  safety  issues  as  they  appear  during  the  course  of  a  clinical  study,  an  increase  in  the  reliability  of  the  clinical  data  collected  and  managed  and  an  overall  decrease  in  the  cost  to  achieve  the  previous  items.                       Integrating  Trial  Data  Process  Across  Functional  Areas  using  Electronic  Data  Capture  (EDC)  Technology