1. Risk Management
DIA Working Group 22 May 2017

2. DIA GCP R2 Risk Management
Project Management ISO 21500
Project phases
Risk Management
What is a risk?
Sources of risks in studies
Risk life cycle
Risk management – FMEA approach
Discussion
Next steps
22 May 2017
DIA GCP R2 Risk Management

3. Project Management ISO 21500
Initiating
Define scope based on the RFP
Project assumptions
Feasibility
Planning
Proposal & Budget
Resources
PM assignment
Project Core Team
Project baseline
Implementing
Critical path
Project-specific Plans
Project team & training
Project Set-up
Controlling
* Controlling project execution from SIVs to TMF archiving
Closing
* Contract review
* Formal acceptance of deliverables by Sponsor
* Admin & financial closure, 3rd parties’ contract end
* Archiving of legal docs
* Evaluation & lessons learnt
* PM release
22 May 2017
DIA GCP R2 Risk Management

4. DIA GCP R2 Risk Management
22 May 2017
DIA GCP R2 Risk Management

5. What Is a Risk?
A risk is any uncertain event that, if occurs, may prevent the project realising the stakeholders’ expectations as stated in the agreed business case of project definition.
PROJECT SCHEDULE
Contains inherent unknowns
If not resolved, impact the schedule and/or outcomes
Occur to become
RISKS
ISSUES
22 May 2017
DIA GCP R2 Risk Management

6. Do not confuse with risks!
Constraints
Do not confuse with risks!
Constraints are those things that are imposed on the project, knowingly or unknowingly, that you cannot control and have to live with them throughout the life of the project or work around them to achieve your objectives.
Risk
Constraint
22 May 2017
DIA GCP R2 Risk Management

7. Clinical Study & Risk-Based Thinking
& milestones
TIMELINES
What can go wrong and cause the study to fail? RISKS
SCOPE
BUDGET
What do we need to do in order to succeed?
RISK MANAGEMENT
Enrollment target
Participants’ Safety
Data quality
Study integrity
Site
Data
Patient
What I do to make it happen …

8. Sources of Risks in Studies
Sponsor
Protocol
ICF
Data Capture System
Geography
Vendors
Technologies
Sites
Patients
Therapeutic area
IMP
22 May 2017
DIA GCP R2 Risk Management

9. DIA GCP R2 Risk Management
Risk Life Cycle
Identify
Analyse
Assess
Treat
Monitor & Review
22 May 2017
DIA GCP R2 Risk Management

10. Risk Management Process
Identify risks
AVOIDANCE -> Revise strategy
Monitor action & contingency plans
Decide primary response strategy
TRANSFER to 3rd parties
FMEA Form
RESIDUAL RISKS
For critical & major by default, for minor as needed
Derive mitigation plans
Assess impact, probability & detectability
Major
Moderate
Minor
Assign responsibility for each risk
Categorise risks
22 May 2017
DIA GCP R2 Risk Management

11. What could go wrong in my AoR at any time during this project?
Risk Identification
Team brainstorming;
Key stakeholders’ engagement;
Customer involvement;
Checklists from past projects.
What could go wrong in my AoR at any time during this project?
CONSENSUS
AoR = Area of Responsibility
Core Team Meeting
22 May 2017
DIA GCP R2 Risk Management

12. DIA GCP R2 Risk Management
Risk Priority Number RPN
RPN
Detection
Probability
Impact
Example
Impact: Major
Probability: Possible
Detection: Controls not failsafe 2
RPN: 4*3*2 = 24
22 May 2017
DIA GCP R2 Risk Management

13. DIA GCP R2 Risk Management
FMEA Form
Get agreement of stakeholders on risk acceptance & mitigation approach for each identified risk!
22 May 2017
DIA GCP R2 Risk Management

14. DIA GCP R2 Risk Management
22 May 2017
DIA GCP R2 Risk Management

15. DIA GCP R2 Risk Management
22 May 2017
DIA GCP R2 Risk Management

16. DIA GCP R2 Risk Management
Next Steps
22 May 2017
DIA GCP R2 Risk Management

17. DIA GCP R2 Risk Management
22 May 2017
DIA GCP R2 Risk Management