PowerPoint Presentation Module 8 Managing Communication and Managing Risks Building rapport Building healthy collaborative working relationships is vital on a study team. You with each person,...

PowerPoint Presentation
Module 8
Managing Communication and
Managing Risks
Building rapport
Building healthy collaborative working relationships is vital on a study team. You with each person, and between other team members.
Important to establish connections based on different personalities, interests, working styles, etc. Take an interest in what is of interest to others.
Building rapport
Be a reliable team member – follow through and do what you say you will do. Apologize when needed.
Keep confidences when asked (and if you can't, say so)
Demonstrate respect for all team members in your conversations. Save any concerns you might have about individual performance for discussions with the person themselves.
Communication
Open and two-way
Say specifically what is needed and/or...
Ask for input and ideas on tasks and projects
Discuss what is needed and who will do
Repeat back the feedback/decision
Communication
Ask what the person needs in order to accomplish
Decide timelines (by when) - Urgent? Less so?
Check for understanding
When communication isn't enough/adequate, find other ways, state the issue and problem solve with the person, etc.
Explore various tools – text, email, team huddles, 1:1s, etc
Planning and communication meetings might include
Internal
Programmatic/divisional priority meetings
Nuts and bolts planning and implementation meetings with study team
PI huddles
Budgets/contracts meetings
Other groups as needed
External
Sponsors
Multisite collaborations
Local subs
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Communication plan example
Risk management
Anticipating, planning, and responding to risks
Risk in research
Research is inherently risky because it is often investigating the unknown
Some amount of risk is necessary in order to fuel innovation
But, there are project-related risks which can derail progress which need to be proactively identified and managed
Common risks in clinical research
Technology issues
Inefficient processes
Supply delays
Institutional ba
iers
Recruitment problems
Forecasting risks
Take a look at the protocol with your team (the more experience and eyes, the better)
Can you identify tasks or processes that might be challenging to accomplish?
Are there parts of the protocol that are contingent on each other?
Are there supplies or equipment needed?
Are there other internal or external groups that execute part of the protocol (like a lab or clinical team)?
What institutional or other processes might be needed (besides IRB, will you need IBC, administrative approval, etc.)?
Are there other institutions involved and what do they require?
Risk planning
As much as possible, plan out what your team will do to try to mitigate the known risks (timelines, prioritization, etc.)
Write a plan for each risk – look at potential problems and plan for them
Example – risk of outside lab needed for research. What steps will you need to take to find out what paperwork or processes or funding etc. is needed to involve this lab? Will contracts be needed and if so what are the process risks with those?
Example – multiple committee approvals needed. What order do they need to be done in? What are some of the known issues/delays with each group?
Think about the unknown risks and how you might identify, escalate, and address those as they come up
Manage the unexpected
Successful projects have proactive leaders and teams
Have an SOP in place for risk and issue management
Very important to develop risk assessment with entire team/collaborators in order to get multiple perspectives
Risks should be reviewed by the study team on a regular basis
Blanco, H. June 18, 2020. Dealing with the unexpected: Covid-19 and risk management. Clinical Trials. https:
www.clinicaltrialsarena.com/analysis/clinical-trial-risk-management/​
Cornerstones of risk management
Strategize (successful study implementation)
Problem solve potential pitfalls (of study implementation)
Anticipate problems (with study population, vendors, resources, funding, staffing, sites, and others)
Have systems in place to deal with issues when they arise
set up redundancies of effort/cross training when possible
make sure issues are regularly discussed and escalated
team should identify the abnormal whenever it comes up
discuss risks whenever talking about projects and tasks
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SOP for risk management
How frequently risk will be assessed
Cross functional team involvement in risk assessment
Risk score based on impact and likelihood
Proactive actions to reduce risk
Pre-defined actions to take if risk becomes an issue
Blanco, H. June 18, 2020. Dealing with the unexpected: Covid-19 and risk management. Clinical Trials. https:
www.clinicaltrialsarena.com/analysis/clinical-trial-risk-management/