CDM's Role in Supporting Risk-Based Monitoring

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CDM's Role in Supporting Risk-Based Monitoring

  1. 1. The  FDA  Guidance  of  Risk-­‐Based  Approach  to  Monitoring  as  Viewed   From  CDM   Presented  By   William  Gluck,  PhD   VP,  DATATRAK  Clinical  and  ConsulEng  Services   DATATRAK  InternaEonal,  Inc.        
  2. 2. Agenda  InteracEons:  Sponsors,  Clinical  OperaEons  and  CDM  Risk-­‐Based  Monitoring   –  Challenges  for  Sponsors   –  Challenges  for  Monitors   –  Challenges  for  CDM  ImplementaEon  –  Will  there  be  any  affect  on  data   quality  or  integrity?  Will  the  Risked-­‐Based  Approach  require  roles/skill  set   adjustments?  
  3. 3. TradiEonal  Paper-­‐Based  Work-­‐Flow  Pa#ent  Data   Database      
  4. 4. Data  Flow  &  Monitoring:  The  Future   Centralized   CRACRC Database     CDM
  5. 5. SupporEng  Risked-­‐Based  Monitoring  –   Challenges  for  Sponsors  •  “The  most  important  tool  for  ensuring  human   subject  protecEon  and  high-­‐quality  data  is  a  well-­‐ designed  and  arEculated  protocol.”  •  Guidance  intends  to  assist  sponsors  in  developing   risk-­‐based  monitoring  strategies  and  plans   –  Tailored  to  the  specific  human  subject  protecEon  and  data   integrity  risks  of  the  trial   –  Focuses  on  criEcal  study  parameters   –  Encourages  use  of  a  combinaEon  of  monitoring  acEviEes   –  Encourages  greater  reliance  on  centralized  monitoring   pracEces,  where  appropriate  –  it  is  OK  not  to  do  100%  SDV  
  6. 6. SupporEng  Risked-­‐Based  Monitoring  –   Challenges  in  Clinical  OperaEons  •  Trial  specific  •  Describe  monitoring  methods,  responsibiliEes,  and   requirements  •  Components  to  consider   –  DescripEon  of  monitoring  approaches  (e.g.,  Eming,   intensity,  acEviEes,  documentaEon)  –  Targeted  SDV   –  CommunicaEon  of  monitoring  results   –  Management  of  noncompliance   –  Training  and  study-­‐specific  informaEon   –  Monitoring  plan  amendments  
  7. 7. SupporEng  Risked-­‐Based  Monitoring  –   Challenges  in  CDM  •  Centralized  Monitoring  •  Quality  and  Integrity  Checks   –  Increased  checks   –  Increased  data  collecEon  •  Technologically  Few  Challenges  •  Process/Workflow  Flow  –  KEY!    
  8. 8. Data  Quality/Integrity  •  IdenEfy  criEcal  study  data  and  processes,  e.g.   –  Endpoints   –  Serious  Adverse  Events   –  RandomizaEon/  Blinding   –  Consent   –  Eligibility  Criteria   –  Risks  specific  to  protocol  design  and  conduct  •  Perform  and  document  a  risk  assessment  to  idenEfy  risks   to  these  criEcal  data  and  processes  •  Design  plans  tailored  to  address  important  and  likely   risks  idenEfied  during  risk  assessment  
  9. 9. Role  or  Skill  Set  Adjustments  Needed   to  Support  Risked-­‐Based  Monitoring  •  Sponsors  •  Site  Coordinators/Staff  •  CRAs/Monitors   –  Increases  in  support  and  technology  skills  •  CDM   –  Increases  in  technology  process   –  Increases  in  training  skills  
  10. 10. Summary  •  From  the  perspecEve  of  CDM   –  Need  coordinaEon  in  planning  across  funcEonal   groups/departments   –  No  overwhelming  hurdles  to  implementaEon  •  Guidance  reflects  acknowledgment  that   changes  to  the  clinical  trial  enterprise  are  OK  •  Process  integraEon  is  key  to  efficient  use  of   resources  and  to  add  quality  
  11. 11.     William  Gluck,  Ph.D.  VP,  DATATRAK  Clinical  and  ConsulEng  Services   Datatrak  InternaEonal,  Inc.   Phone:  919-­‐651-­‐0222   Cell:  919-­‐522-­‐9681   E-­‐Mail:  Bill.Gluck@datatrak.net  

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