Jane Tucker presents on risk management in clinical trials. She discusses the basic risk management methodology of identifying risks, analyzing them, prioritizing significant risks, and planning mitigation actions. Tucker also covers how to structure effective risk statements and documents risks in a log or register. Participants learn that risk management adds benefit by focusing resources on the greatest risks and ensuring key tasks are completed.

1. W E B I N A R
By Jane Tucker
Stay Tuned…

2. What are we going to cover
• Introduction
• DDi & TULA
• Topics in Risk Management in Clinical Trials
Basic risk management methodologyBasic risk management methodology
Utilize the basic principles to take a 'risk-based
approach' to a clinical trial
Document risks identified
Prioritize risks and plan mitigation actions where
necessary
Tools utilization for effective management &
automation
• Q & A
2

3. Our Speaker - Jane Tucker
• 30 years in the pharmaceutical industry• 30 years in the pharmaceutical industry
Jane has been involved in a number of
different disciplines
• Jane specialized in Quality Risk
Management, facilitating risks assessment
sessions, documenting and managing risks
and training staff in risk management
• More than 5 years hands on experience risk• More than 5 years hands on experience risk
management within clinical trials, process
improvement and software development
projects
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4. DDi & TULA
4

5. Operation in 7 Key Countries across GlobeOperation in 7 Key Countries across Globe
750+Successful Clinical Trials
Smart Products: mEDC, mIRT, mPORTAL, safeXchange
Smart Solutions: ClinMetanoia, TULA, dattasa
55 Copyright @ 2015 DDi. All Rights Reserved

6. • TULA is an effective Risk Management Solution that aids
conversion of risks into opportunities.
• A Solution which will focus on areas that present the greatest
66
risk to human safety and data integrity.
Copyright @ 2015 DDi. All Rights Reserved

7. BenefitsFeatures
A platform to monitor full cycle of a
project or portfolio of projects
Reduce number type and severity of
All Risk management
activities at 1 place
Reduce number, type and severity of
events
Interactive dashboards and reports
Timely alerts and escalation
Standardizing Risks
Effective Metrics
management
Timely alerts and escalation
Audit trails and role based
accountability
Easy integration
Reduce Compliance issues
77 Copyright @ 2015 DDi. All Rights Reserved

8. Basic Risk Management
Methodology
8

9. Regulatory Background to Risk Management and
MHRA Expectations
ICH Q9 Quality Risk Management
Two principles
The evaluation of the risk to quality should be
based on scientific knowledge and ultimately
linked to the protection of the patients
The level of formality, and the documentation of
the quality risk management process should be
commensurate with the level of risk
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10. ICH Q9
Overview of a typical Quality Risk Management Process
Initiate
Quality Risk Management Process
Overview of a typical Quality Risk Management Process
Risk Assessment
Risk Identification
Risk Analysis
Risk Control
ation
Risk Ma
Risk Evaluation
Unacceptable
Risk Communic
anagement Tools
Risk Reduction
Risk Acceptance
Output/Result of the
Quality Risk Management Process
1010
Risk Review
Review Events
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11. What is Risk Management?g
11 -- IdentifyIdentify
22 Anal sisAnal sis
55 -- ControlControl
22 -- AnalysisAnalysis
44 -- TrackTrack
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33 -- PlanPlan

12. What is Risk Management
• Risks assessment to identify risks
• Analysis to priorities the risks
I t ( )Impact (or consequence)
Likelihood (or probability)
.. and now Detectability
• Planning to manage ONLY the most significant
• Track …... then Control
• NOT a tick box exercise!!!NOT a tick box exercise!!!
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13. What is Risk Management
Ri k i di i li h dd• Risk management is a discipline that adds
benefit to any activity
• Risk management ensures that all available
resources are utilized where they add the
greatest benefit
• Risk management ensures that tasks that areRisk management ensures that tasks that are
'always done', but may not necessarily be
mitigations for a significant risk, can justifiably
be left undone
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14. The 5 Steps of Risk Management?
1 Id if1 – Identify
• What is the root cause?
• What is the risk?
2 – Analysis
• What is the impact/consequences?
• What is the likelihood?
Communicate at all times
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15. Risk of Scoring Matrix
VERY HIGH (5) 9 16 20 23 25
HIGH (4) 13 18 22 247
LIHOOD
MEDIUM (3)
LOW (2)
4
2
11
6
15
12
19
14
21
17
LIKE
LOW (2)
VERY LOW (1)
2
1
6
3
12
5
14
8
17
10
IMPACT
VERY LOW (1) LOW (2) MEDIUM (3) HIGH (4) VERY HIGH (5)
1515
IMPACT
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16. The 5 Steps of Risk Management?
3 – Plan ‐ ONLY for the most significant risks
• What can be done to lessen the impact?p
• What can be done to reduce the likelihood?
• What can be done to increase the detectability?
• Can someone else handle this better?
Communicate at all times
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17. The 5 Steps of Risk Management?
4 T k4 – Track
• Are the planned actions being implemented?
• Are the responses effective?p
5 – Control
• Is the original risk under control?
• Have any changes occurred?
• Are there any new risks?
Communicate at all timesCommunicate at all times
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18. How to structure a Risk Statement
Risk statements need a root cause ‐ Because of .....
• Because of• Because of .....
• … there is a risk that .............
• … resulting in ........................
• Because eDiaries may not be accepted by
patients there is a risk that vital data are
not collected resulting in compromised
statistical analyses
• Because stocks and shares can go up as
well as down there is a risk that the value
of investments may decrease resulting in
decreased capital
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19. How to structure a Risk Statement
What are the advantages of a statementWhat are the advantages of a statement
structure?
Detailed enough to be understood
by anyone who reads itby anyone who reads it
Risk Registers or Risk Logs may need
to be passed down through
b f j t t dmembers of a project team and can
stand the test of time
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20. How to structure a Risk Statement
How the statement structure can add benefit
The relationships between risks
arising from the same root cause arearising from the same root cause are
clear
It can clearly been seen where one
iti ti ti t llmitigation action can actually
mitigate a number of risks
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21. How to Structure a Risk Statement
• Because of .....
• … there is a risk that .............
• … resulting in .......................
• Because eDiaries may not be accepted by• Because eDiaries may not be accepted by
patients there is a risk that vital data are not
collected resulting in compromised statistical
analysesanalyses
• Because eDiaries may not be accepted by
patients there is a risk that Investigator sites
may not want to be involved resulting in lack ofmay not want to be involved resulting in lack of
power for the statistical analysis
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22. Utilize the Basic Principlesp
to take a ‘Risk-Based
Approach' to Clinical Trials
and Programs
22

23. How to utilize Risk Management in a Clinical
Trial
Clinical trials involveClinical trials involve
• Human subjects/patients
• Unlicensed chemical entities
• Scientific advancements
• Contractual agreements
• Huge amounts of time/money/resources• Huge amounts of time/money/resources
• Corporate investment
• Public perceptions/opinions
• ............................!!!!!!!!!!
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24. Why & How
• Patients want to know they are safe
• Regulatory authorities need assurancesg y
• Contracts/legal requirements must be met
• Approval for budgets must be obtained
• Corporate image must be maintained
• Public opinion must be shaped
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25. How to get started
Any time!!
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26. Integration into a clinical trial
Write protocol and IB
Start to identify root causes
Select sites and gain approvals
Identify all risks, analysis and plan responses
Recruit patients
Track responses and identify/analyse/plan
Collect/clean data and monitor sitesCollect/clean data and monitor sites
Control responses and identify/analyse/plan
Finalise database
Stats Analysis and report
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27. Initiate Project
2727 Copyright @ 2015 DDi. All Rights Reserved

28. How to Utilize Risk Management in Clinical trial
• Start with identifying the 'stakeholders'Start with identifying the stakeholders
Study team lead
Data management
Clinical trial supplies
Monitor
StatisticianStatistician
Principle Investigator
Representatives of contractors
..... etc
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29. How to Utilize Risk Management in Clinical trial
• Identify
P t ti l R t C l t d tPotential Root Causes related to
clinical studies
Recruitment
Use of technologyUse of technology
Resources
.... etc.
Then brainstorm risks related toThen brainstorm risks related to
each root cause
• Analyse
Agree Impact/Consequence and
Likelihood
Derive the Risk Score or Risk Level
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30. How to Utilize Risk Management in Clinical
Trials
• Plan ‐ ONLY for the most significant risks
Identify the actions to be takenIdentify the actions to be taken
Identify who will actually perform those
actions
When does the action need to be
reviewed?
• Track
At regular intervals the Study Team
should review progressshould review progress
• Control
As the study progresses regularly review
the Risk Register or Risk Log and check
for any risks that can be closed or new
risks arising
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31. When & Who?
• Write Protocol and IB
Who is involved at this stage?
Core trial team members
Drug development team representatives
.... any others?
Risk Management activities
What risks have been identified by the drugWhat risks have been identified by the drug
development team that need addressing?
Identify risk triggers related to phase, study
population and locations, PK and PD results,
etc.......
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32. When & Who?
• Select sites and gain approvals
Risk Management activities
Take all previously identified risk triggers and
use those as a basis for a brainstorm on
potential risks
Once brainstorm is complete risks should be
scored and prioritized
Responses should then be agreed ONLY for the
most significant
Ownership of the responses and time‐frames
should be documented in the risk register/log etcshould be documented in the risk register/log etc
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33. When & Who?
R i P i• Recruit Patients
Who is involved at this stage?
• Collect/clean data and Monitor sites/
Who is involved at this stage?
• Finalize Database
Who is involved at this stage?
• Stats Analysis and Report
Who is involved at this stage?Who is involved at this stage?
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34. Risk Documentation
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35. Remember to Structure Risk Statement
• Because of .....
… there is a risk that .............
… resulting in ........................
• Build your risk documentation around that• Build your risk documentation around that
structure initially
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36. Risk Identification
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37. What should Risk Documentation look like?
• Whatever works for you!!
• 'Team' friendly
N t t h d t ilNot too much detail
Not too technically complex
Accessible by everyone who is on
the team or owns responses
Managed by one person
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38. What should Risk Documentation look like?
• Need some easy way of uniquely identifying
each risk to ease tracking and communication
• Multiple risks in rows per sheet rather than one• Multiple risks in rows per sheet rather than one
sheet for each risk
• Spreadsheets make for easy sorting by Ids/ Risk
Scores/Owners/Due DatesScores/Owners/Due Dates
• Include a method for tracking ongoing progress
• Call it a Log, Register, RMP .... whatever!!!
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39. When & Who?
• Minimum contents
Risk ID – numeric or alphanumeric,
sequential
Risk statement
Risk score
Response (or N/A)Response (or N/A)
Response Owner
Response Actions (if necessary)
Response Due Date
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40. Risk Documentation
Risk
Driver
Root
Cause
Because
...there is
a risk that
...resulting
in...
Impact
(Very Low=1
Low=2
Medium=3
High=4
Likelihood
(Very Low=1
Low=2
Medium=3
High=4
Risk Score Action Owner(s) Review by
(dd/mm/yy)
Because
of...
Very High=5) Very High=5)
Because
eDiaries
may not
there is a
risk that
resulting
in
i
ay o
be
accepted
by
patients
s a
vital data
are not
collected
compromi
sed
statistical
analysis
4 3 19
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41. Risk Documentation
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42. Risk Documentation (Register)
4242 Copyright @ 2015 DDi. All Rights Reserved

43. How Risk Management adds value
• Everyone who participates in the risksEveryone who participates in the risks
assessment will have an understanding of the
whole picture and where the problems are
likely to be
• The whole team gets to meet at the outset
• There are never adequate resources available,
but risks assessments ensure that resources are
allocated where they will deliver greatest
benefitbenefit
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44. How Risk Management adds value
• Once risks are identified scored and prioritized• Once risks are identified, scored and prioritized,
it is then possible to justify to senior
management why some actions are NOT being
under‐takenunder taken
• The whole team meets, and starts to
communicate, from the beginning and as such
make a really positive start
• It is a structured process, that sets a good
discipline across the team
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45. P i iti Ri k d PlPrioritize Risks and Plan
Mitigation Actions where
necessaryy
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46. Prioritization of Risks
• Use that scoring from the Impact and
Likelihood
• Sort the list of risks by score to get the biggest
at the top
• Review the whole list as a team and determine
how far down the list you will aim to go initially
(you may only take on the top 10 risks)
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47. What to do about the Risks
• Responses to risks can take 4 forms
Avoid – i.e. make major changes
Mitigate – i.e. take action to reduce likelihood
or impactor impact
Accept – i.e. take no further action
Transfer – i.e. pass the risk to someone else
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48. Risk Mitigation
4848 Copyright @ 2015 DDi. All Rights Reserved

49. How do you decide What actions to take and
How to manage them?
• Only take action if the risk is high priority
• Only take action if it is within your sphere of influenceOnly take action if it is within your sphere of influence
If it's not, can you transfer the response to
someone else?
i h ld b d b h i l• Actions should be owned by the appropriate people
The person who will actually do the work
Not the 'Team Leader' for everything!! y g
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50. How do you decide What actions to take and
How to manage them?
O i k d l i l i• One risk may need multiple actions
That's OK ‐ but each action needs an owner
Track the progress for each actionp g
• Only allocate one person as many actions as they can
actually manage
• Start with the most significant risks and work down the• Start with the most significant risks and work down the
list in order of priority, that may mean only tackling
3 or 4 risks at the start
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51. Risk Tracking
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52. Risk Management Results
• Any risk management activity will improve the
quality of your trial – mainly by limiting waste
of resourcesof resources
• The study team will be focussed on the
activities that will deliver maximum benefit
Th t ti b b d th• The team meeting can be based on the
progress of risk management activities
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53. Summary
There are 5 steps within risk management andThere are 5 steps within risk management and
a regulatory Expectation of a ‘risk based
approach'
All members of the clinical trial team should beAll members of the clinical trial team should be
involved in the risk management for the trial.
Risk Management should be an ongoing
process through‐out the whole trialprocess through‐out the whole trial
Risks can be documented in any way that the
team finds helpful, as long as it is regularly
reviewed and updatedreviewed and updated
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54. Thank you for your time !Thank you for your time !
For any questions, please email to
5454
For any questions, please email to
tula@ddismart.com