0
Streamlining Mid-Study Changes                with Technology
How many studies have you seen                   that   do not have a mid-study change?Confidential – 2
zeroConfidential – 3
Completed protocols across all clinical trials incurred an      average of   2.3 amendments      Each required an average ...
and those numbers are growing…                   Protocols are more complex                   CRFs are larger             ...
What’s the impact?Confidential – 6
What’s the impact?                   Time delays                   Cost overruns                   Regulatory riskConfiden...
Why do these impacts occur?Confidential – 8
Why do these impacts occur?                     Design                     Test       Change       Management    Approve  ...
Why do these impacts occur?                     Staggered deployments due                     to IRB approvals        Depl...
Why do these impacts occur?                     Moving data from Version 1                     to Version 2        Data   ...
Why do these impacts occur?                       EDC                       Coding        Multi-system        Impact      ...
Factors that affect time, cost and risk                        Change Management        Mid-study       Deployment Challen...
What role should technology play?Confidential – 14
What role should technology play?                        Inclusion / Exclusion                        Range checks        ...
What role should technology play?                      Reduce cost        Improve       Accelerate timelines        Operat...
How can technology                    support real-world changes                     and improve operations?Confidential –...
Overcoming challenges.                          Change Management    Does the tool support a process-oriented approach to ...
Overcoming challenges.                          Change Management    Does the tool produce supporting documents like blank...
Overcoming challenges.                                          Change Management    Does the tool identify what changed b...
Overcoming challenges.                           Change Management    Can you easily and consistently move study revisions...
Overcoming challenges.                                  Deployment Challenges    What utilities are in place to support th...
Overcoming challenges.                         Deployment Challenges    Does the update cause downtime or data entry    in...
Overcoming challenges.                           Data Migrations    Use a tool that does not have to move data for mid-   ...
Overcoming challenges.                            Multi-system Impact    Don’t lose sight of today’s connected environment...
How can the process flow?Confidential – 26
How can the process flow?                            Design    Identify the change (e.g. a simple edit-check update)    De...
How can the process flow?                            Test    The tester loads the version, reviews the configuration    di...
How can the process flow?                           Approve    Clinical reviews the modification and approves the    versi...
How can the process flow?                            Deploy    The project manager coordinates the deployment with    the ...
In summary…Confidential – 31
Mid-study changes happen      Factors that create delays, add cost and risk include:             Change management        ...
®from Concept to Cure!                         ™   with D ATATRAK ONE!                         DATAT R A K International  ...
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Streamlining Mid-Study Changes with Technology

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Transcript of "Streamlining Mid-Study Changes with Technology"

  1. 1. Streamlining Mid-Study Changes with Technology
  2. 2. How many studies have you seen that do not have a mid-study change?Confidential – 2
  3. 3. zeroConfidential – 3
  4. 4. Completed protocols across all clinical trials incurred an average of 2.3 amendments Each required an average of 6.9 changes to the protocol Phase III studies required 8.5 changes per amendment http://csdd.tufts.edu/news/complete_story/pr_ir_sep-oct_2011Confidential – 4
  5. 5. and those numbers are growing… Protocols are more complex CRFs are larger Clinical trials are lasting longer Clinical trials are globalConfidential – 5
  6. 6. What’s the impact?Confidential – 6
  7. 7. What’s the impact? Time delays Cost overruns Regulatory riskConfidential – 7
  8. 8. Why do these impacts occur?Confidential – 8
  9. 9. Why do these impacts occur? Design Test Change Management Approve DeployConfidential – 9
  10. 10. Why do these impacts occur? Staggered deployments due to IRB approvals Deployment Challenges Manual deployments are subject to human errorConfidential – 10
  11. 11. Why do these impacts occur? Moving data from Version 1 to Version 2 Data Migrations Site downtime Lost dataConfidential – 11
  12. 12. Why do these impacts occur? EDC Coding Multi-system Impact Randomization CTMSConfidential – 12
  13. 13. Factors that affect time, cost and risk Change Management Mid-study Deployment Challenges Change Challenges Data Migrations Multi-system ImpactConfidential – 13
  14. 14. What role should technology play?Confidential – 14
  15. 15. What role should technology play? Inclusion / Exclusion Range checks Support Real- World Changes Extension visits …to name a fewConfidential – 15
  16. 16. What role should technology play? Reduce cost Improve Accelerate timelines Operations Lower riskConfidential – 16
  17. 17. How can technology support real-world changes and improve operations?Confidential – 17
  18. 18. Overcoming challenges. Change Management Does the tool support a process-oriented approach to change management? Design Test Approve ReleaseConfidential – 18
  19. 19. Overcoming challenges. Change Management Does the tool produce supporting documents like blank CRFs and annotated CRFs?Confidential – 19
  20. 20. Overcoming challenges. Change Management Does the tool identify what changed between study revisions so that you can support risk-based verification? Change Version 1 Version 2 1 – Age Are you 18 or older? Are you 17 or older? Question Text 2– 35.0 < temp < 37.0 35.0 < temp < 37.3 Temperature Edit CheckConfidential – 20
  21. 21. Overcoming challenges. Change Management Can you easily and consistently move study revisions through separate design, test and approve environments? Design Test Approve Release Study Revision 2Confidential – 21
  22. 22. Overcoming challenges. Deployment Challenges What utilities are in place to support the mid-study deployment process? Change Type Element Utility Add Edit Check Reconcile data Remove Edit Check Reconcile data Question (All Add Update Questions Patients) Question (Specific Add Patients) Change answer Update Question Type options Remove QuestionConfidential – 22 Add Form
  23. 23. Overcoming challenges. Deployment Challenges Does the update cause downtime or data entry inaccessibility for the sites?Confidential – 23
  24. 24. Overcoming challenges. Data Migrations Use a tool that does not have to move data for mid- study change updates. If you have to move data in the tool, create a “checksum” script to ensure the data are safely transferred from one version to the next.Confidential – 24
  25. 25. Overcoming challenges. Multi-system Impact Don’t lose sight of today’s connected environments! If your EDC is connected with Coding, CTMS, Randomization, lower risk with a Change Assessment Checklist Is anything changing that might affect connections with other systems?Confidential – 25
  26. 26. How can the process flow?Confidential – 26
  27. 27. How can the process flow? Design Identify the change (e.g. a simple edit-check update) Designer makes the change in the online development environment, reviews her work and flags the version for testing.Confidential – 27
  28. 28. How can the process flow? Test The tester loads the version, reviews the configuration difference report and is ensured only the temperate edit was modified (release classified as low risk). The tester runs tests, everything passes and they flag the version for UAT.Confidential – 28
  29. 29. How can the process flow? Approve Clinical reviews the modification and approves the version.Confidential – 29
  30. 30. How can the process flow? Deploy The project manager coordinates the deployment with the study team. A mid-study change utility is run to identify data that falls outside the updated normal range. The sites are never down.Confidential – 30
  31. 31. In summary…Confidential – 31
  32. 32. Mid-study changes happen Factors that create delays, add cost and risk include: Change management Deployment challenges Data migrations Multi-system impact Technology should Support real-world changes Improve operations Process-oriented technology appropriately applied can help Reduce cost Accelerate timelines Lower riskConfidential – 32
  33. 33. ®from Concept to Cure! ™ with D ATATRAK ONE! DATAT R A K International Cleveland, Ohio Bryan, Texas Cary, North Carolina 888.677.DATA (3282) Toll Free www.datatrak.net
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