Clinical
Research Project
Management
Topic = "Recruitment Strategies"
Please write a brief paper answering the following questions:
1. What are some recruitment challenges a study might face?
2. What strategies would you use to promote equitable access to
research?
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 6 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 barriers 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 14 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/