Speaker 1: Hi everyone. Welcome to CHI Rounds. Just before we get started, a couple of announcements. Thank you for filling out the evaluation for this presentation and leaving it in at the basket at the entrance to the theatre. If you haven't received one already, you will be receiving an electronic survey from CHI. This is a survey that we've developed to help us improve our rounds and to ask you about some topics and identify opportunities for presenters in the future. I filled out the survey. It took me about five minutes, so thanks for taking five minutes of your time to help give us some feedback going forward for our rounds. My name is Sarah Kirby. I manage the Health Systems Performance Platform at the CHI, and I also function as a Research Project Manager. Today, you're going to hear all about research project management. We are fortunate to have some very strong staff today to provide a presentation to us. Brendan Foote has been with us since about 2014. He has almost 20 years of experience managing clinical and health research projects. He's been participated in over 50 clinical trials and health research projects, as well as consulted extensively in research administration and management. He is currently working on several national clinical trials running through our office, as well as other research projects. He provides a great deal of leadership and mentorship to our Research Project Management Collaborative at the CHI. Also presenting today is Pusha Sethi. She's been with us for about three years at the Centre and also brings a strong background supporting clinician scientists and conducting their research. She's currently working on a number of national, large and extensive research projects, as well as some local research projects. Today, in our audience, we have members of our Research Project Management Collaborative. They could raise their hands here, Husseini, and right across here. So we're happy to answer your questions following this presentation, but also at any point, you can reach us on Twitter at CHIMBCA, and you can also reach us through our website, CHIMB.ca, where you can contact us directly or you can learn more about our future and upcoming events. So without further ado, I would like to welcome Brendan to start off the presentation.

Speaker 2: Great. Thanks, Sarah. I guess you can hear me, because I can hear myself. Just to get an audience temperature. So how many of you are project sponsors? If you can just kind of raise your hand. How many of you are project, like working as nurses or research coordinators in projects? And how many of you are administration personnel? Okay, good. So I'm going to try to cover the gamut. Obviously, we only have about 45 minutes to do this, so I'm going to try to do the best that I can. Typically, a presentation around project management can be anywhere from 3 hours to 10 hours, and I'm trying to, we're going to try to condense that down into 45 minutes so that we can have some, plenty of time for questions and answers. So our objectives today, the learning objectives are, is because this is an educational component, we're going to, hopefully you'll be able to answer why project, formal project management is important in clinical health research, what the role of a research project manager is and when one's needed, what approaches, techniques, and tools a research project manager brings to a research project, and what are CHI's service offerings, and how research project managers can be engaged, and you can tap into those service offerings. What we're going to do today is we're going to kind of walk through a few things, and this is what we, sort of the outline of why project management is important in a research environment. We're going to talk about some of the approaches, techniques, and tools that we bring in research projects, what research project managers are and what they are not, what project management services are offered at CHI and how you can access those services, and then we'll again have time for questions and answers at the end. So let's get right to it. The Project Management Institute is a body, international body that a lot of our project managers follow. They follow the project management body of knowledge, and they define what a project is. They define a project as a temporary endeavor undertaken to create a unique product, service, or result, and I like to add this element. I like to add that it involves a commitment or investment of resources. Even if the resources are in kind, it's still an investment. Somebody's investing into it. Projects can be very diverse. They're diverse in size. They're diverse in complexity. So for example, they can be small, meaning that you're the project manager. You're responsible for the deliveries. It's a one-man show or a one-woman show. They can be large in that there's a lot of stakeholders, there's a lot of moving parts, and there's lots to manage within that project. It can involve international, national sites, national stakeholders, collaborators, product delivery, product support, contributors. There could be a lot of individuals in there. It can be traditional in that we kind of know what the process will be. We'll follow kind of a waterfall approach, so it's a step-by-step progressive process within the project. It can be complex in that there's a lot of interaction and dependencies between certain components within a project. And it can be innovative, and with innovation brings a lot of unknowns, unknown potential risks. We can't really leverage subject matter experts necessarily because we just don't have that in an innovative project because typically innovation means that it's never really been done before. It can be compliance-driven, and let me explain that a little bit. So we often within research have to comply with regulations, legislation, Tri-Council Policy Statement, ICHGCP. Sometimes these legislations and these guidances, they change. Recent change, for example, to the NAPRA guidelines. I'm not sure how many people know. Anybody knows what the NAPRA guidelines are? NAPRA guidelines are guidelines that pharmacies follow. And there was recent change in those guidelines that actually changed the way that some of the pharmacies were using, were adhering or complying with before-use dates of specific drugs in the absence of stability data. So that made quite a bit of a change in the way that costs were now determined. So imagine that you've got a project and all of a sudden a new piece of legislation comes out, and now it costs you more money because your drug usage is now 14 days as opposed to 60 days because of the new guidelines. Recent changes last year in ICHGCP, for example, are putting more emphasis on quality for the sponsor. And a lot of our trials that we deal with, a lot of our research is investigator-initiated trials. So we could be responding to compliance versus tactical or strategic. So this would be more in the line of I'm doing a printer optimization upgrade, or I'm doing something to further my business need, or strategic, which is more sort of longitudinal. So I want to create a center of excellence within five years. Known outcome versus investigative discovery. So this is the case where we kind of already know what the outcome will be. It's very, again, it's a very traditional project. We know what falls, what steps will fall in, and we know what the known deliverable is going to be. It's very predictable, basically. Investigative could be a pilot study. We don't know what the outcome will be. We just know that we want to do it because we want to answer a question. Research is often driven by protocols. So we have a protocol-driven project, or we have a plan-driven. So operational project might be more sort of plan-driven. But it doesn't really matter the size of the project, the complexity, the innovative nature of the project, whether it's compliance, whether it's strategic, practical, known outcome. Every project deserves a good project plan because good project plans equals good, poor project plans, rather, equal poor results. And you could end up with something like this, something like this, or my personal favorite, something like this. So why do projects fail? Well, you can quite often find all kinds of literature on why projects fail. I've put eight of them up here, and I'll just kind of go over them briefly. But not obtaining the right resources within the right skills. Inadequately defining and managing the requirements of the project. Not developing realistic estimates, schedules, timelines. And we see that one quite often. Failing to set and manage expectations. Not deciding or communicating who is responsible for what. I put going rogue here. How many people have been left out of the loop? I bet you every person would put their hand up. Inadequate budgeting and budget management. Inadequate project planning and execution to a plan, and not proactively identifying risks and putting in contingency plans to manage those risks. Again, another thing that we frequently see in projects. The Project Management Institute has actually identified three categories of why projects fail. People, process, and communications. There's been all kinds of literature over the year that have shown that communication is the number one reason why projects fail. 1996, Keeley et al. said that 56% of all projects fail because of poor communication. Project Management Institute has also cited communications and lack of stakeholder involvement as reasons why projects fail. And the think tank GoHub has also indicated that communications is one of the number one reasons why projects fail. There are challenges in research projects. Well, in any project really. So not just necessarily risks, but there are also challenges that we need to overcome. So for example, projects may involve ill-defined or excessively broad scope. What are we doing? I don't know how many times project managers have heard that. I don't understand why this project is happening. Are we boiling the ocean or are we boiling water in a teapot? Funding can be restricted or its sources are unreliable. CIHR grants or any type of grant funding is restrictive. Your decisions are constrained to your budget. There's no contingency funds available. Projects may require novel tasks and specialized skills. I've a couple projects that required this. Placebo manufacturing. Who's going to do that? Case manager. We have a case manager here that may need to do a readiness assessment. Those are specialized skills that may need to be involved in projects. What may be standard of care or practice may be unacceptable in the eyes of the regulator. I put this one up because I've seen this happen three times where a sponsor is interested in doing a clinical trial or a project and they quickly discover that in the eyes of the regulator or the authority, it could be the privacy officer or whatever, when they say this is the standard of care, this is what we always do, in the eyes of the regulator, it doesn't matter. They're still subjected to submit a clinical trial application, investigational testing authorization, even though across the country it can be clearly demonstrated. Now there's some movement in Health Canada to kind of recognize that, but that has been an issue with some trials where clinical trials applications have been required because it's not recognized by the regulator for the proper indication or proper use of a medical device or product. And accessing data is not as straightforward as we thought. Does the data exist? Where does it exist? Is it in the format that you expect it to be in? And how accessible from a privacy perspective is it? And will privacy allow you to have access to that or your project team to have? So there are quite a few challenges and that's why a project management is really necessary to sort of help navigate those challenges and those risks of failure.

Speaker 3: Okay, so we'll get into what project management itself is. So according to the project management body of knowledge, PMBOK, which CHI we follow, project management is defined as the application of knowledge, skills, tools, and techniques to activities to meet the project requirements. Practically, project management is the process of managing projects using tested tools and techniques while blending in process improvement and change management. So what is a good project management principle? Good project management will help define what project success looks like and how it's measured. This is achieved through defining key performance indicators, metrics, and project deliverables. It helps lay out things in a predictable and pragmatic manner to allow the project sponsor to know what to expect and when to expect it. Through the use of tools like a project breakdown structure or a project plan, it helps control, monitor, and ultimately satisfy sponsor expectations. And this is achieved through project planning, the conduct of structured meetings and project status reports, and optimizes organizational resources, processes, and budget use achieved through quality monitoring and also monitoring and control of staffing allocations, schedules, and cost accounts and variances. Oh, you can't hear me? Can you hear me now? Can you hear me? Can you hear me now? Yes? Okay. So good project management will also help monitor and mitigate risks and issues and help to guide the response when an issue occurs. This is achieved through risk plans, issues logs, and decision plans, and also through the use of good communication plans. It also helps optimize and control how change is managed, achieved through a change management plan. If the studies or the project is quite complex, we'll bring in change management expertise to account for that portion of a study. It helps determine when things should happen and who will make it happen through staff management plans, which includes assessment of the assignment of roles and responsibilities using tools like a skill matrix. An example is a RACI matrix, which assigns resources as responsible, accountable, consultative, or informative, so that we know who's responsible for what and what deliveries are assigned to them. And it provides a written record of the project for lessons learned, as well as controls and monitors vital project milestones and activities. Project management follows a project or project managers follow a project management methodology throughout the life cycle of a project. For us, we use PEMBOK, the project management body of knowledge. These five process groups allow a measured and documented initiation, planning, execution, monitoring, and controlling, and the closure phases of a project. Projects may involve only one cycle, or depending on the complexity of a project, involve multiple iterations of these processes. So depending on what kind of project you're using, it could be quite simple, have a single cycle, or if it's a multinational, multi-site project, you may have multiple phases and you have executions and closures of different parts of that project. As projects are diverse and there are many types of project, there are many methodologies with different approaches and applications that have been developed. Depending on the project and the skill set of the project manager, any of these methods or combination could be deployed in a project. As the project progresses, different methodologies may be pulled in when appropriate. The goal of this approach is to analyze and reduce risk as you move through a project cycle, always updating the project. So as Brenda mentioned, if it's a simple project, like a traditional project, we may use a waterfall iteration where the steps are quite defined. If it's complex and innovative, we might use agile, where we're adapting as we're moving through the project cycle. If there's lots of change management, we may bring in expertise in pro-C. If it's more complex, we may bring in more expertise in pro-C. If it's more operational and we're implementing a new procedure or we're trying to streamline a procedure, we may use lean techniques. So depending on the style of project, we may use different methodologies. These are well established and there's evidence to why these methodologies are used. Project management is really using those expertise that have been developed in the practice to inform how we execute a project. Just like there are subspecialties in medicine, there are subspecialties in project management as well. Well-known examples in the field are IT and construction. Research project management is also a subspecialty that follows the overall project management principles. Here at CHI, we've defined it as research project managers provide goal-oriented support to the research community through the application of globally accepted project management principles, methods, tools, and techniques as a means of advancing the delivery of high quality, high impact, innovative, academic, operational, and patient-oriented research. So that's how we define whether a project is qualified for CHI to partake in. As pointed out earlier, projects are diverse and research project managers can have a diversified portfolio of protocol-driven research projects or operational research projects. Since CHI's inception in 2008, RPMs have been engaged in educational material development for a wide variety of research support and administrative groups, including training. So it could be training of health leadership or it could be also training of research staff. Policy and procedural projects within the WRHA, University of Manitoba, and within the provincial government. Operational process and qualitative improvement projects. Planning implementation and monitoring of qualitative research projects. Planning and implementation of research networks and communities of practice. Development of research and clinical programs. Strategic planning and project management of system transformation projects. An example of this would be the Rhythm Initiative. Project management of observational and interventional clinical trials through the project life cycle. From grant development, so we'll help you put together a grant package, to the final publication of research findings. So we'll take you through the full cycle of a research project. RPMs have been engaged by a vast network of project sponsors from the University of Manitoba, Manitoba government, WRHA, Cancer Care, the Children's Hospital, and Research Manitoba, just to name a few. And we're always looking to work with new programs and entities as well.

Speaker 2: Okay, so, okay, where are we here? Oh, there we are. Okay, so I'm going to get in now into the nuts and bolts of what the research project managers' responsibilities really are when it comes to project managing, as you saw, a wide diversity of projects. Research project managers don't just do research protocol type projects, they also do operational strategic projects as well. So the responsibilities are pretty wide and very, very, and very project specific. Sometimes other project team members may take on various aspects of the roles that project managers would typically take on. So I'm just going to basically speak as a project manager that would be basically all in, to kind of give you an idea of what the responsibilities are, and I'm going to get into some of the tools that we use and the techniques and approaches, and how valuable those tools and techniques and tools are in specific projects. So project managers are responsible for for maintaining the project scope, budget, schedule, and resources to ensure the project objectives are met while balancing the triple constraint priorities set by the project sponsor. So the project sponsor is going to tell you, as a project manager, what the priority is. So for example, a CIHR grant, it's cost restrictive. You know that you only have so much funds that is constrained. Your schedule may not be constrained, it may be optimized, and what may be acceptable to the project sponsor is the quality of that project. Managing and controlling communications, action items that arise outside of the project, of the planned work activities, monitoring risks, their probability, their occurrence window, and their potential impact on the project's objectives, and issues that might arise where decisions and changes need to be made, and assisting the navigation and the response of those issues and those challenges. And the way that it is done is that it's coordinated, integrated them across multifunctional lines, ensuring consistency and approach and alignment across working groups and implementation strategies, and ensuring appropriate deliverables are in place to proceed. The project manager is often responsible for developing plans and documentation. There are several plans that are developed that facilitate keeping the project organized and tight and on track. And I'm going to get into some of them, and they're considered as baseline documents, and they really sort of inform the execution and the monitoring and the controlling of the project. It keeps everyone in the project informed, the stakeholder expectations are managed, and it helps, again, monitor and control the project. So RPMs have assisted in the development of the project, data capture tools, essential study documents, SOPs that are required by regulations, by policy, and even in some cases service agreements. And I think the biggest thing that project managers do is they establish and maintain relationships and networks with KOLs, subject matter experts, collaborators, team members, and they're really sort of the go-between and liaison individuals for the projects. The project manager has also provided consultative support for budgets, for agreements, research grants, protocol development. I've been involved in a lot of the protocol development stuff, not so much the scientific pieces but the logistical pieces, study material development, and of course project management. Compliance and regulatory management for regulatory, legislative, and policy preparation, regulatory inspection, ICGME, trial requirements, trial registration requirements, and then of course consultative support for regulatory compliance in terms of what the regulators are looking for, how you're going to maintain your compliance in terms of ethics, health ethics impact, privacy, as well as local, provincial, and federal legislation. Project managers are often tasked to source and procure materials. Just last week I was sourcing materials for a trial that involved, that needed bottles for storing of the study drug, sourcing subject matter experts, sourcing key opinion leaders. They've conducted facilitation sessions with strategic planning, brainstorming activities, training and managing the performance of research personnel, whether that's through workshops or presentations, and leveraging their network connections to provide multi-organizational, multi-platform, multi-professional engagement. They have a wide variety of project stakeholders locally, nationally, whether they are contributors, collaborators, or part of the project team. So I'm now going to start getting into some of the tools that we use. One of the big tools that we use is the project plan. And the project, although project managers are typically emerged, engaged in the project from start to the finish, a lot of emphasis is placed at the very beginning of the trial. So the PMBOK, which is the Project Management Body of Knowledge, defines the project plan as a formal approved document used to guide both project execution and project control. The primary uses of the project plan are to document planning assumptions and decisions, facilitate communications among project stakeholders, and document approved scope, cost, and scheduled baselines. It's a baseline document to which we'll control the execution, controlling, and monitoring of your of your project rather. And really what it does is it sets up the stage for defining what the work is, any project changes, guiding the process around that, the communications, schedule, quality, risks, procurement activities, and the project team. Although this is an initiating document and not part of the project plan, I thought it would helpful to put this one up. Most people are familiar with a project charter. The project charter is really an initiating document. It formally acknowledges the existence of a project. It is usually signed off by a senior executive, a sponsor, or the executive sponsor. And it recognizes and provides the project manager with the authority to start using resources on the project. The project charter informs, it's really a high-level document that informs the project planning. It contains things like detailed background information, what the problem is, what the plan solution is, what are we going to do, what are we going to achieve out of this, what's the objectives, who's going to be involved in the project from high level. Not every team member may be listed in the charter. The detailed purpose, the goals, the objectives, the timelines, scope, and your approach. What are the boundaries of the project? Are we just going to do it in this clinic or are we going to do it in all clinics? The key inputs and outputs, assumptions and constraints, resource allocations. So we have got 2.6 million dollars to do this in. It doesn't get into the breakdown of every single granular detail, but it gives us a high-level number in terms of the resource allocation that we have and the leadership and resources of the project. Really what a project charter aid is, is our agreement from the sponsor for the scope, time, and budget mandates that the sponsor has. The scope statement I think is really important in projects because what this does is it helps define the parameters of the project, its boundaries, and the project objectism deliverables. And a good scope statement is going to give you the justification, which really is a brief statement regarding the business need, your project addresses, a product scope definition, so the characteristics of the product, services, or results that you're going to produce, and then acceptance criteria. These are all things that project managers in research will work on and develop. Sometimes the scope statement is embedded within the project plan or embedded within the project charter. One of the critical pieces of the project plan is the work breakdown structure. What the work breakdown structure is, and quite honestly it's fairly straightforward, is that it helps lay out the activities that are required in the project. This directs which individuals are responsible for those activities and informs the schedule and the project costs. So from that work breakdown schedule I'm able to determine the level of effort, the level of duration, what my costs are, but what it also does is it helps me determine what the risks are going to be. When I look at that work breakdown schedule and I look at that schedule, it also gives me an idea of when those risks are likely to occur and when that window of opportunity is when that risk is passed. So the PMBOK defines the work breakdown structure as a decomposition of the total scope of work to be carried out by the project team to accomplish the project objectives and create the required deliverables. So again, the work breakdown structure is very important in informing what activities there are going to be in the project. Project team management plan. So what this does is, and Pusha alluded to this earlier, is really it documents who's responsible for what, where does the accountability lie, and who's informed and how are they informed, when are they informed, who's consulted, and it basically outlines who's going to be doing what in the project at what given point. And it could include, as she pointed out, things like the racing matrix, the skills and experience matrix. So sometimes we use the skills and experience matrix when we have a team that we're not familiar with, and what that does is it helps us understand where the skill sets lie so that we can assign individuals who have that skill set to be the primary and who the secondary individuals will be as their backups should there be something that occurs like, for example, employee turnover. Cost management strategy or cost management plan, and the plan details and establishes how costs are established, estimated, the invoice and payment milestones, processes, can also include, in some cases, can even include a revenue stream if you've got some revenue that are coming in. Sponsors may not have the time to really adequately source what costs will be, particularly project managers will often obtain quotes from vendors, they've consulted on the development of budgets for proposals, critical baselines, where funds where, where they're going to lie, and in particular monitoring the costs during a clinical trial. Some grants, they pay, they pay milestone payments. Monitoring the burn rate, as I like to call is really critical in some of these trials because you don't want to run out of money because you know that your April 1st, you're going to get your next payment. So if you're all up front and you're recruiting like crazy in a multi-centered clinical trial and you're making payments based on those milestone payments, you may, you know, you have to manage that. You have to make sure that you're not going to be running out of money. The cost management plan can help mitigate that because it sets the pace, helps you set the pace and control the pace. Communication is huge. Communication, even in a small project, communication plans are helpful because it, it puts on paper how I'm accountable for, for communication and for my sponsor in terms of what I'm going to be reporting, when I'm going to be reporting it. It controls not only the document flow and where those documents are going to particularly go, but what they will contain, what medium, what format, when they're to be delivered. So for example, project status reports, project progress reports, performance reports. It spells out all of that. Meetings are part of communication. When are meetings held? What they will, what will they occur? What's the purpose of them? Will they be bi-weekly? Will they be once a month, quarterly? And what will be, what's the purpose of those meetings? What's the communication objective? What's the strategy? What's your audience? What's the message? Will it be a standing agenda or will it be a flexible agenda? So it reduces conflicts, duplication of effort and lays confidence in stakeholders' perception regarding the project and really the role of the sponsor is, as a leader, is reflected more positively when there's a good communication plan. So project-related meetings like steering and team meetings, when they occur, what's the communication objective and target audience, project reporting, when it occurs and when, and whether reporting recruitment activities in a clinical trial, for example. Many of you that are study coordinators may, when you're doing industry-sponsored clinical trials, you may be sending off your enrollment measurements on a weekly basis to the sponsor. That's part of the communications plan. That's something that would go into a communications plan. So a communication plan is typically done at the very front end of the project. It's usually done one time, but it also needs to be maintained and monitored to ensure that there's compliance within that plan. To build these plans and not follow them is, it would just be pointless to create all these plans. This is a plan that is growing more in clinical research and it's called the Quality Management Plan. And just like the Project Management Plan is what I call an omnibus plan that has a bunch of subsidiary plans like the Work Breakdown Structure, the Project Team Plan, so is the Quality Management Plan. And there are a lot of things that go into the Quality Management Plan and people may not realize that that's where they really should fall. We're seeing more and more of data safety monitoring board requirements for projects. That's the terms of references and the governance, that's where they would go under the quality because again it speaks to patient safety and quality. If you have a clinical trial that's, for example, being monitored for data quality, the monitoring plan would go under your quality. What are you doing for training? Is it just ICHGCP training that you can get through CORE or is there actual specified training on special assessments and so on and so forth? That's where that would go. What about your specifications? Let's say you have a medical device that you're using, what are the tolerance levels, what are the specifications, what are the error rates, accepted error rates, so on and so forth, that would go in there. Let's say you're using mass spec on urine samples and blood samples, what are your validation, what are your calibrations, your calibration records, that would all go in there. Statistical Analysis Plan, Health Economics Analysis Plans, again speaks to quality, would go on the quality management section. The other thing that would go in here too is the Data Management Plan, which really speaks to data validation, data rules, assumptions, data checks. So you can see now we're really building a bigger plan with just under one header of quality. So there's a lot that goes in there, particularly with it really informs sort of your tolerances and what needs to be delivered in terms of getting a good quality results in projects. And of course we wouldn't be good project managers if we didn't have risk mitigation strategies, looking at risks with our potential issues that can occur, identifying what the probability is, what the potential impact is, and what the window of opportunity is, when those risks are going to occur. We use the work breakdown structure for that. We can look at the activities that are being planned and say okay with this work activity there's a potential that this may or may not happen. What's our response to that? Are we going to accept it? So for example, a great example is what happens if we have a 10% negative variance or we're below recruitment and we're 10% below recruitment? That might be acceptable because it's a two-year project, we can catch up over time. But what happens if we're 25% below recruitment? Is that acceptable? And if it's not, what's our response? Is our response to look at our inclusion exclusion criteria and make an adjustment? Is our response to engage other sites, what we call rescue sites? That can all go in here. And risks mitigation is quite important when it comes to good proper planning so that you're prepared when something happens, you immediately know what you're going to do as a result of that. What are you going to do with the results afterwards? A good strategy is to have KT plan. Are you going to notify your patients, let them know what the results were, what treatment arm they were in, and how are you going to do that? How are you going to mobilize the data? Where is the data going to reside after it's done? Is it going to go to open source? Is it going to be locked in a filing cabinet somewhere? What's the KT management, the knowledge translation? Project managers can assist with that, leveraging our knowledge translation platform in CHI, we often do that. They're the subject matter experts around knowledge translation. We as project managers may not have the subject matter expertise in knowledge translation, but we certainly would leverage the subject matter expertise of our platform around that. Same with patient engagement, we would do the same thing. We would leverage our expertise of our patient engagement folks, Carolyn Schimann up there and her team there. CIHR defines patient engagement as meaningful and active collaboration in governance, priority setting, conducting research, and knowledge translation. Depending on the context of patient-oriented research, it may also engage people who bring the collective voice of specific effective communications. I think the next line is an important piece here. They go on to say that patient-orientated research refers to a continuum of research that engages patients as partners, focuses on patient-identified priorities, and improves patient outcomes. This is becoming more and more popular now, obviously, because of the directives from CIHR. Patient engagement strategies are being more involved, and specialists are being more engaged, and we would, as project managers, would leverage those subject matter expertise of our subject matter experts. So these are some of the planning. This doesn't contain everything. We have, you know, there's configuration management plans. There's all kinds of other subsidiary plans that go in there, but these are the basic main ones. Then once the project is executing, we need to maintain and monitor that. We have to maintain and monitor that those plans are in compliance, because they are your baseline documents, and baseline documents can be amended. They can be changed through decision requests and change requests. So project managers are often tasked with doing progress reporting, status reporting on cost accounts, milestones, discussing what variances are, again, recruitment variances, cost variances, schedule variances, escalating issues, and managing action items and decision requests.

Speaker 3: Okay. So as you can see, project managers wear many hats. We're planners, directors, problem solvers, librarians, sometimes subject matter experts, salesmen, and we can perform a variety of tasks, but what we are not are the following. So we're not study coordinators or administrative support. We can be consultative and guide these activities, but don't be often carry out the protocol. This includes study visits and data collection. We're not medical experts, of course, although several have a good foundation in medical terminology and process. We're not able to provide medical guidance. Regulatory experts, again, some have expertise and can help navigate these systems, but cannot be regulatory or legal experts. Biostatisticians or data managers. We can support the documentation and creation of a data management plan, but are not experts in data quality or analysis. So when is a project manager needed? As project management professionals, we like to say always, but that may not be practical given the financial challenges of project sponsors. So project managers have become adaptive and consultative, providing hands-on project management when required and consulting and training when having a project management may not be feasible or when the funding is tight, but there are some situations where we feel that a project manager may be recommended. So when a project is quite large, innovative, or complex, so multi-center RCTs, network development or large grants, when there are numerous communication channels or stakeholders, when you require human resources or management of those resources, and when you need to consult on a project plan or a business case. If at any point you're unsure whether a project manager is required or not, just reach out and ask us. We're happy to meet with you for any size of projects. As previously stated, CHI research project managers have a wide variety of projects, including protocol execution, so a traditional project or a traditional research project, or operational, so system changes. RPMs can be used to fully deploy a project, so full-time on a project, partially dedicated for specific deliverable, so like a business case or a project plan, or provide consultation and training. There's a wide variety of opportunities to engage us. The starting step is really to talk to us and see how we can effectively support you in your project. There's a few ways you can reach us. You can go to our website and download the intake form, or you can reach us at info at chimb.ca to set up a consult or an intake. Questions and answers?

Speaker 2: Any questions? Great. The number one question that I often get from study coordinators and research assistants are, what are the main plans that I should be using in planning the project? Communications planning is key. That's the number one. The risk plan is another very key one. The risk plan is another very good one. Your work breakdown, because the work breakdown helps identify potentially what the risks will be, even if they're high level. Some of the activities that you know that you're going to be doing in your project, how is that going to inform the risk? Of course, your costs, because most projects are governed or constrained by certain cost accounts. Funds are earmarked for staff, and you may not have any buffer to go outside of that. Developing a mitigation around what happens if your costs exceed, what are you going to do, and how are you going to deploy that? Those are probably the main, at minimum, plans that one should develop. Quality as well would be a good one, of course, because there's a lot of elements within the quality, but I would say communications plan, risk plans are probably the two main priority ones. Great. Okay. Thank you very much.