1. Streamlining Mid-Study Changes
with Technology

2. How many studies have you seen
that do not have a mid-study change?
Confidential – 2

3. zero
Confidential – 3

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_2011
Confidential – 4

5. and those numbers are growing…
Protocols are more complex
CRFs are larger
Clinical trials are lasting longer
Clinical trials are global
Confidential – 5

6. What’s the impact?
Confidential – 6

7. What’s the impact?
Time delays
Cost overruns
Regulatory risk
Confidential – 7

8. Why do these impacts occur?
Confidential – 8

9. Why do these impacts occur?
Design
Test
Change
Management Approve
Deploy
Confidential – 9

10. Why do these impacts occur?
Staggered deployments due
to IRB approvals
Deployment
Challenges Manual deployments are
subject to human error
Confidential – 10

11. Why do these impacts occur?
Moving data from Version 1
to Version 2
Data
Migrations Site downtime
Lost data
Confidential – 11

12. Why do these impacts occur?
EDC
Coding
Multi-system
Impact Randomization
CTMS
Confidential – 12

13. Factors that affect time, cost and risk
Change Management
Mid-study Deployment Challenges
Change
Challenges Data Migrations
Multi-system Impact
Confidential – 13

14. What role should technology play?
Confidential – 14

15. What role should technology play?
Inclusion / Exclusion
Range checks
Support Real-
World Changes Extension visits
…to name a few
Confidential – 15

16. What role should technology play?
Reduce cost
Improve Accelerate timelines
Operations
Lower risk
Confidential – 16

17. How can technology
support real-world changes
and improve operations?
Confidential – 17

18. Overcoming challenges.
Change Management
Does the tool support a process-oriented approach to
change management?
Design
Test
Approve
Release
Confidential – 18

19. Overcoming challenges.
Change Management
Does the tool produce supporting documents like blank
CRFs and annotated CRFs?
Confidential – 19

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 Check
Confidential – 20

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 2
Confidential – 21

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 Question
Confidential – 22
Add Form

23. Overcoming challenges.
Deployment Challenges
Does the update cause downtime or data entry
inaccessibility for the sites?
Confidential – 23

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. 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. How can the process flow?
Confidential – 26

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. 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. How can the process flow?
Approve
Clinical reviews the modification and approves the
version.
Confidential – 29

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. In summary…
Confidential – 31

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 risk
Confidential – 32

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