Clinical
Research Project Management
Topic - "Project Planning"
Please write a brief paper answering the following questions:
1. Once a clinical research study is funded and starting up,
what would be important elements to include in planning your team's work? What
would you prioritize?
2. What documentation would you need during startup of the
clinical research study?
PowerPoint Presentation Project Planning and Management in Clinical Research Project manager is responsible for 3 main things Manage project communications Monitor and manage project progress Budget management "Webinar: The Role of the Project Manager in Research." (1:00:34) https://www.youtube.com/watch?v=0J20SZ3rq7Q Project planning and management When done well, it can lead to successful clinical trials Control scope, time, cost, and quality Include risk assessment and risk management Ensure system for communication is built into your plan Outline clear decision-making roles and responsibilities Start the project plan at the beginning of the study and include the entire scope of the protocol Hosely, M. Project management & Planning for Successful Clinical Trials." September 1, 2020. And "Webinar: The Role of the Project Manager in Research." (1:00:34) https://www.youtube.com/watch?v=0J20SZ3rq7Q 3 Project management plan variables Take the grant proposal and/or protocol and translate it into a practical project plan Think about what local SOPs may be needed to develop and carry out the research at your site Talk through the details and the logistics of how your team will conduct the study Determine how you will monitor the activities of your team in order to ensure timely and correct completion of activities 4 Planning phase What problem (or study aspect) needs to be solved? Who will be involved? What steps will be taken to solve the problem? The problem presented to you to fix or do may not be the one that needs to be fixed – need to look at root causes Very important to ask questions about what is needed, in order to develop solutions that actually fix the problem 5 Project plan elements Clear objective(s) stated – what Timelines for completion of various activities – who, how, and by when Resources needed for the work – what and who Accountability of people involved – who does what Communication system planned - how Risks assessed and planned for - what Hosely, M. Project management & Planning for Successful Clinical Trials." September 1, 2020. and Farrell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, 78 (2010). htttps://doi.org/10.1186/1745-6215-11-78 6 Clear objectives around things like Patient outcomes Study outcomes Investigator outcomes Team process outcomes ...use SMART goals 7 Scope of work With research studies there is usually a general scope of work that outlines what the site is responsible for in terms of deliverables However this document is usually a formality and not detailed enough You should instead look at the protocol and determine the scope of what your teams needs to do Determine scope Many projects or studies take on too much and underestimate the resources needed In my experience recruitment and coordinating efforts are notoriously underestimated Can use something called Work Breakdown Structure (WBS) to try to get a more realistic idea of what is needed 9 Work Breakdown Structure (WBS) What will have to be done in order to get x done? Keep asking that question until it is broken down into tasks that cannot be subdivided further Estimate how long each task will take – person hours to do HBR Editors. The Four Phases of Project Management. November 3, 2016. 10 Work Breakdown Structure example Work Breakdown Structure example Deliverables diagram Gantt Chart Project plan template Timelines Account for study startup time which can be lengthy Deadlines for IRB and other review committees Length of project and key deliverables Enrollment windows 16 Timeline example Resources Define your resources What staff are needed to complete a protocol, or multiple protocols simultaneously as is more often the case Where are the gaps – escalate and advocate for more 18 Creating a schedule Work backwards from drop-dead deadlines What deliverables are due when Who does what Calculate task timelines 19 Monitor and track project progress "Watchtower" What is happening with the study and are we meeting the goals or objectives that we need to be Are our processes working as we think they should be Making course or effort adjustments as needed Monitoring project scope and making sure team members aren't being pulled away from their primary objectives and projects. Say no to things outside scope. Sometimes the scope does change, but then need to re-negotiate efforts/time/quality on other activities in order to make this change Budget management Pre-award Prepare the budget for the study Make sure the budget covers the staff needed to accomplish activities Post-award Monitor expenditures on the study – purchases, staff time, patient costs Spend per the funder and institutional requirements Post-project Prepare for audits Close out the study Key takeaways for project planning Relationship and team building Clear communication around project tasks and goals Control project scope Manage timelines Adequate budget to do the work, and cost control Adequate resources – people mainly The goal is to control time and resources in order to accomplish scope in a high quality manner