Risk Mitigation for Statisticians

In today’s episode, I discuss the crucial topic of risk management in clinical trials with guest Jess Thompson. Jess, the founder of the Association of Clinical Research Project Managers, shares her extensive experience in the field, emphasizing the importance of proactive risk identification and collaborative communication within project teams.

The conversation delves into practical strategies for risk assessment, impact scoring, and contingency planning, highlighting the significance of involving all team members, including statisticians, in the risk management process.

We talk more about the following key points:

  • Understanding Risk Management
    We discuss the importance of continuous risk assessment and proactive planning throughout a clinical trial’s lifecycle.
  • Risk Identification
    We discuss the importance of collaborative risk identification, the role of assumptions in assessment, and aligning team members’ timelines for successful project completion.
  • Risk Assessment
    Jess explains the importance of collaboration and input from team members when assessing risks using a 1 to 10 scale in order to accurately evaluate the likelihood and impact of identified risks.
  • Contingency Planning
    Risk scoring, mitigation options, risk tolerance, contingency planning, and documentation/communication are essential for successful risk management.
  • Risk Reporting and Lessons Learned
    Status reporting is an important tool for activating necessary plans, recognizing successes, and fostering a collaborative atmosphere while also documenting risks.
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Jess Thomson

Industry Disrupter – Founder of ACRPM – Consultant | MS, CCRC, PMP

As a Project Manager, she leads and oversees multiple global clinical trials in various therapeutic areas, ensuring timely and quality delivery of project deliverables within budget and scope. She has over 12 years of experience in clinical research, with certifications in Clinical Research Coordination (CCRC) and Project Management Professional (PMP).

She is also the founder of the Association of Clinical Research Project Managers (ACRPM), a global professional organization that connects, educates, and supports clinical research professionals who employ project management tools and methodologies to achieve successful outcomes. Her mission is to advance the field of clinical research project management and enhance the well-being of CRPMs worldwide.


Risk Mitigation for Statisticians

[00:00:00] Alexander: Welcome to another episode of the effective statistician. And I’m super happy to talk about a very, very important thing today with Jess. Hi Jess. How are you doing?

[00:00:13] Jess: Hi, I’m doing great. How about yourself?

[00:00:16] Alexander: Very good. It’s in the middle of the summer here. It’s still pretty hot in Germany, as we recorded and this topic that we’ll talk about today is also, you know, always a hot topic because there’s this kind of famous kind of words like everything can happen in a clinical trial.

And you know, all kind of different risks can come up and risks are there for any project. Yeah. Even if you run on a project, let’s say on some kind of capability improvement or process improvement or these kinds of things, we always have these kinds of different projects and it’s really good to kind of think about risks beforehand, mitigate them, learn from them and all this kind of things.

And the umbrella term for that is risk management. And so Jess from her background has a lot of experience. So, but before I kind of dive into this topic, just maybe you can introduce yourself a little bit into your background.

[00:01:25] Jess: Yeah, absolutely. So my name is Jess Thompson. I am the founder of the Association of Clinical Research Project Managers. I actually started out in a lab many years ago. We won’t do the math there because that’ll just hurt my feelings. But I started in a lab moved to a coordinator position, then moved to more of a regulatory position, then into Clinical Trial Management and then project management. I’ve worked at sites. I’ve worked at CROs and most recently I’ve worked at sponsors and across all of that. I kind of saw a very common theme of we always had so much technology, but we did not have the training and training is really 1 of those things that we need in this industry more than anything, because we could have all the technology in the world, all the best technology there is.

But if people don’t know how to actually manage a study, or even just some of these. Smaller topics, like risk management or change management we’re kind of setting ourselves up for failure. So that’s really the goal behind the association of clinical research project managers, but also taking into consideration. I think we all learned through cobit and through the pandemic, how important it is to really take care of ourselves as well. So, my goal with is to really look at project managers. As a whole person, not just a productivity engine and to really break down that horrible idea that there’s only one project manager in a clinical trial.

Everybody’s a project manager because we are all managing very important pieces of the project, which feed into this very, very large project. But we all do utilize project management skills and resources and tools. No matter what your role is study coordinators, statisticians, CRAs. All everybody in clinical research is truly a project manager. And that’s really kind of the message that I’m trying to get out there just so that we can increase training and resources and make sure that our projects are successful.

[00:03:15] Alexander: Completely agree. And the more advanced you get into your career, the more you will need these skills. The projects only will get bigger, more complex, and so on. More people get involved. You not only have, you know, people from your company, but you may have several different vendors and all kinds of different things can happen in this world. And so, at least since COVID, we also know that a lot of things can happen that we didn’t expect.

[00:03:47] Jess: That’s so true, right? Who had on their risk management plan that a global pandemic would occur? Because I know I didn’t.

[00:03:53] Alexander: Yeah. Okay. So let’s dive into the topic. So let’s start, you know, as a mathematician from the background, I always start with what is the definition of risk management?

[00:04:06] Jess: Sure, so I’m going to not give the super classical definition. I’m going to kind of give what realistically, you’re using risk management for. So, risk management is really an iterative process. So you’re going to do this throughout the life cycle of your study. Like Alex said, anything that can happen will happen. And we know that with clinical research and a quote that I love to use is failing to plan is planning to fail. And so that was by Ben Franklin. And if we’re not taking the time to really plan our projects, which I don’t know about you, Alex, but I see that all the time.

All the issues of, you know, we’re always so busy and trying to get everything done and we just won’t take the time to really sit back and think about how we’re actually going to do the study. So risk management really allows that time to. You know, identify the risks and then plan accordingly for those risks, but also making sure that the entire team is aware of the risks that are potential and having that input through out the project team that shouldn’t just occur at the sponsor level. That shouldn’t just occur at the CRO level. That should really occur at each organization and each role. So that these risks can be can be managed and identified and mitigated prior to them becoming a bigger issue.

[00:05:17] Alexander: I love that you say getting everybody on the same page. Yeah, it is a communication tool, a very, very effective communication tool. Because we all work in kind of different areas, we will have different perceptions and different thoughts about what are risks. Yeah. Well, just kind of in all the programming things. Lots of different things can happen in a, you know, the working with a vendor or kind of different things can happen.

It’s a science all, you know, says, and everybody can contribute here something. So this is not, you know, the. Oh, that’s done by project management. Statisticians don’t need to worry about it. It’s, this is really, if you don’t worry about it as a statistician, I would say you are not doing your job.

[00:06:07] Jess: Absolutely. And you’ll see by this document that’s gonna be shared as well. I’m a project man manager. I’m not a statistician, so trying to identify risks from the statistician point of view was difficult for me because again, a lot of times risk management is only done by a subset of the team, or even just at a very high level, and then these risks occur that if we had just taken the time earlier on, and just had those open communication lines to say, hey, this can be a problem.

You know, we could avoid so much cost. So many timeline delays. So much stress if we just had these conversations and the more I talk about project management, the more I lean into that project management is such a soft skill that it’s really just teaching how to communicate with your project team rather than most other things.

It’s although. Yes, we are going to talk about risk management, but it really talks about how to communicate these risks to the project team to make it understood and to really make that collaborative environment that I feel like we kind of miss in clinical research. You know, it’s always very broken up between sponsors CRO site where we all really need to work together to make sure that we are doing these projects effectively and efficiently.

[00:07:19] Alexander: Yes, absolutely. As you’re just mentioning this document, this document is kind of a blueprint of risk management for statisticians. And you will find it on the homepage of The Effective Statistician on this episode. And on it, you’ll also find all the contact details for Jess. So if you want to learn more about it, I can highly encourage you to reach out to her. And she can help you in these kinds of things. So let’s talk, go into risk management. The first step is Risk Identification. So how do we actually do that?

[00:08:02] Jess: Sure. So there’s a couple different ways that we can do this. My favorite way is really just kind of tackling it from the beginning of, okay, what is coming to mind that what can go wrong? Right? So for this, I. This fake study that I’m kind of talking about, we talk about, like, slow enrollment, faster enrollment falsified data, incomplete data patients that are lost to follow up like, the funding can be decreased. Another way that you can do this is looking at the objectives or the work order that you are given.

Depending upon how you do your contract in your roles and seeing what the expectations are and what is needed from others in order to actually fulfill your role. So this could be, you know, the, your after data lock, you are analyzing the data. I’m sorry again, not a statistician. So I can’t use the words you guys use.

So Alex, you’re gonna have to put this in statistician, statistician language for me. But really just sitting there and thinking through what can occur. Global pandemic could occur, right? So if a global pandemic occurs, what happens? Then we may not have our patients. We may not have, all the data that we need, we may not make the falsified data could be an issue because we can’t get CRA on site.

So it’s really just taking time to look at what can happen. Of course, this needs to be done as a group. If you’re the only statistician, it’s a small project. What I would recommend is really going through this for yourself and then talking to the project manager or your contact with the study, whoever that may be.

And if you’re the lead, if you do have a team, I would start the list 1st, and then circulate it to your team because then you really want to do this as a team to talk about risk mitigation strategies, contingency plans, the impact all of that. Because some people might see this as. You know, the impact might not be likely because maybe they have some additional information that you don’t have, like, they’ve changed inclusion exclusion criteria or something like that.

So it really needs to be done as a team because. You’ll get the whole picture and then also, because some of your risks will feed into the risks will feed into some of the other risks. So it’s just really important to make sure that that open line of communication and collaboration is existing in this space.

[00:10:13] Alexander: Yeah, if you can, one aspect in risk mitigation that I always look into is what are your assumptions? And just kind of by discussing about these assumptions, you can see that them can be vastly different assumptions. Yeah. In terms of timelines and things like this. And timelines is just an one kind of key aspect.

I know you said many people are measured on timelines. And that leads them to send back the timelines.

[00:10:46] Jess: Yes.

[00:10:47] Alexander: And then they say, well, we’ll probably use. Need 10 months for that. And in their heads they’re thinking, I think six months should be really fine, but I’ll say 10 months. So, you know, if I do it in seven, nobody kind of, you know, rips off my head and sends a statistician saying, oh, I have 10 months to do this.

Oh, I can first do something else. And then, and one six someone says, oh, by the way, we’ll be done in a week. And he says, What? You said 10 months. I thought I still have four months to go.

[00:11:21] Jess: Yes. Yes. And I could talk about timelines all day because that is such a important part of all of this and it’s such a big impact and it increases costs and quality and all of that kind of thing. Because, you know, like you said. You could say this timeline and honestly, we all know zeros are really bad about this too. Whenever they are doing bed defenses and they’re not bringing in the study team to say, oh, yeah, we can get all this done in 6 months. They know, you know, like, then the same team gets it and you’re like, what in the world are you thinking?

We are benchmark is not that. So all of this really feeds into each other, which is why I think it’s so important that we really start to discuss that. Again, project managers aren’t just at the sponsor level. Statisticians are project managers because what they’re working on is a project. So understanding how to evaluate what that timeline is going to look like, how to manage your time accordingly to make sure that again, maybe enrollment is actually quicker than expected.

And then the timeline moves up. That is a risk, but that’s a positive risk because risk can actually be positive or negative and are things that we need to look at. So say that we do have that risk of the data coming in much quicker than the timelines would be different. And we would need additional resources.

We would need to change out resources. But there are options that we can take and put into place on even the positive risks that we identify and how to, you know, either exploit those or accept those or, you know, anything like that to really think about, okay, if this does occur, what do we do, then not, you know, and we have a plan in place rather than, oh, crap, it occurred. What do we do now?

[00:13:02] Alexander: Yep. It’s also, you know, one of the things is you show to your upper management that you thought through stuff. So you can show, okay, these are all the things that we have considered and planned for. And I think that is the next step. Yeah. So risk assessment. Can you talk a little bit about this?

[00:13:23] Jess: Absolutely. So risk assessment is where we start to look at what’s the likelihood of the risk occurring and what is the impact of the risk if it does occur. So just to give an example, enrollment slower than expected. This is always a risk. I I’ve not seen many studies that are going faster than that.

You know what I mean? Then what is expected? So the likelihood of occurring in my perspective is high. I feel like those timelines keep getting smaller and smaller and smaller and sponsors want enrollment to occur faster, but sometimes it’s not, not even possible. So the likelihood of that is high. And so the impact would then be high. You can use impact scoring or sorry, it’s a risk assessment scoring. So I use a 1 to 10 scale just to get an idea of, you know, what the impact could be, or what the score will be. Including the impact and the likelihood, so the impact of occurring would be a 10. The likelihood is a 10 so the score is a 20. And then I usually put in notes, you’ll see all this in the document just so that it would actually really be helpful if you bring up the document while we’re walking through this today because we’re kind of just going straight through the document. So that way you can see it because that’s how I learned.

So I like to make sure that others see that as well. So the timelines would be compromised. That’s just something again, whenever you’re bringing this to the study team, you’ve really thought this through. You’ve really thought about. Okay. How does this impact me? But how does this impact the study as a whole?

Because again, this is all about collaboration. Some of this. Might just be the statistician identifying and then the project manager or the project lead, whoever it might be then creating the scoring and contingency plans. But again, we need to make sure that the study team is involved because you are the experts. You are the SME’s and we need to make sure that you have that input. And I might not know what the impact is of occurring if there’s incomplete data, but you do.

[00:15:12] Alexander: Yeah, and I think from kind of the scoring from 0 to 10 or from 1 to 10, I wouldn’t kind of think too much about it. It is really a way for you to get a feeling for what is more likely and less likely. Yeah, so it’s not so much about whether it’s 9 or 10 or 8 or 9. It’s more kind of in relationship to all the other risks. Is it more likely or less likely? Is it more impactful or less impactful?

[00:15:46] Jess: Absolutely.

[00:15:48] Alexander: Yeah.

[00:15:49] Jess: Yes. And I should explain that a little bit better too. I apologize. So for low, I use a one or a zero. For medium, I use a five. And for high, I use a 10. I make it as simple as I possibly can. And that’s only so that I can show the study team why we need to act on something. So, it’s not really having to go through, like, 1, 2, 3, it’s really like, what’s the likelihood it’s a low, low impact or high impact.

But then just so that we can easily see, because again, a lot of project management is communication skills. Some people are going to see this and think, oh, okay, we have a low and a medium and we can sit on that. But some others may need to see the score, or may need to see it in color to then understand the impact or the reason that we are acting on an issue.

So you’ll see a little bit in again, risk management, the idea here, you don’t have to follow this to a tee. It’s really just to get you to understand the impact and the reason that this should be a team effort rather than a very small subset of the study team working on these risk management plans.

[00:16:52] Alexander: Yep. And here it comes to life. What I mean about communication tool. Yeah. It as you’re putting it into the script. Everybody will weigh in, and some people will say, well, this is low, and some people will say, no, I think this is high. And if there’s disagreements, that usually means that there’s different experiences, different perceptions.

And you can get a common understanding, why is this tool so that’s why it’s really, really nice. And of course, you can also create some kind of scatterplot or something like this, where you kind of see, or these are the high. Risk high impact one sees us a low risk low impact one. So this is probably what we, you know, just need to have a glance over you know, high risk, high impact one, we definitely should have some kind of plan in place. And that is the next step.

[00:17:53] Jess: Absolutely. And I love that you brought in this. I feel like statisticians could have so much fun with this and understand it on a level that I could never. I’m like, Oh, very high level. And you’re like scatter plots. And I’m like, Oh, I just did a colored grid.

So that’s exactly it. The next part is really contingency planning and trying to figure out which of these risks that we’re going to take any action on. It is really important to think about when you’re doing contingency planning that there are usually additional costs in relation to this. But if the impact and likelihood of occurring are very high and negative, it is probably worth that additional cost.

Also, risk tolerance is something that we need to talk about here as well, because. Like you said, Alex, it’s very much 1 of those things that. Okay. Somebody might think that this is high, but somebody else might think this is low. But again, that’s a risk tolerance situation. That is a conversation that needs to be had. We need to understand why 1 person might think it’s low. 1 person might think it’s high, but your organization or your team might have a higher risk tolerance, or they may be very risk averse. So, again, this is going to vary based on your study team. This is going to be very based on your individual. I’m very risk averse.

So anything that I can do ahead of time and have plan A, B, C, D, E, all of that, I’m going to do it, even if it’s additional time on my part, because I know the value of planning for that. And if the risk occurs, I already have a plan in place. I’ve already thought through what we’re going to do. So again, this is really specific to organizations, to study teams, to individuals, but utilizing communication in this and speaking to the study team as a whole, or at least the leaders in each of the different parts of the study team is essential to really start talking about contingency plans for risks.

[00:19:42] Alexander: Yeah. Risk tolerance is another really interesting topic. I’ve really learned first about it and benefits risk assessments. Where I understood, ah, risk tolerance is something that is very, very individual. Yeah. For example you know, if you think about side effects, yeah. And the potential benefit from a treatment.

Very often, physicians are more risk averse. Because they are focused on the safety, whereas patients very often tend to be more risk tolerant, actually, which is an interesting thing. And so that leads them to very, very different decisions. Yeah. And same is here true. Yeah. As a study team, you might be very risk verse your management might be more risk tolerant.

And say, yes, that’s great, but we don’t want to spend more money on it. We just absorb it. Yeah, exactly. Could be, yeah. And here, it’s again, it’s a communication tool. Yeah, you can show, okay, this is what you could do. Do you want to invest? You know, all the time or money and kind of this mitigation plan or don’t you want to do it?

[00:21:03] Jess: Absolutely. And that’s such a good point. But also I think that documentation, if it’s not written down, it doesn’t exist. That is one of the keys in project management. If it’s not written down, it does not exist. So bringing these risks up to your management or to the study team and then choosing not to act on those covers you that makes it known to management that, hey, I brought this up. If something were to occur and they decided to be more risk tolerant than what you were advising, you have that documentation to say, I did bring this up at the beginning of the study. And these are the options I presented. But the study team chose to, you know, utilize something else, which is what we’ll go into it.

That leads perfectly into the next section of what our contingency plans are. So as a study team, you really start to think about. What your contingency options are based on your risk score or again, you don’t have to use risk score. You can utilize the likelihood and the impact scoring. But then we talk about negative risk contingency options.

So we can avoid the risk completely. So that’s just eliminating the risk at the beginning. Just get rid of it. I think for this one, I really think about, you know, a really busy schedule of activities. If we, you know, we want patients to be seen every day for seven days, patients don’t want to do that if we don’t need that data.

So we would avoid that. So we could just change the schedule of activities on this one. Again, this is a bigger study team conversation, but it is 1 of those things that if you identify it, it can bring up the conversation. Mitigating a risk would be planning ahead to introduce additional plans to decrease the likelihood or to decrease the impact.

So, a good 1 for this 1 is we could say data is falsified. The study would then use risk based monitoring to and run regular data checks to look for any trends. Accepting it is just saying, okay. I know that the risk is there, but we can’t really do anything about it. We just have to say if it happens, we’ll deal with it.

Then transferring the risk. So, this one’s a little bit harder. I think in clinical research, but I always use vacations as an example for this. So, say, I book a vacation, it costs me a lot of money instead of me taking the risk of losing that money. If something happened, I buy travel insurance. I’m transferring that risk to somebody else.

But again, not all risks are negative. So there’s positive risk contingency options as well. So if we think that maybe enrollment is going to be faster and we really want to work with that. We want to complete enrollment quicker. We would exploit it. So we would increase the likelihood of that risk occurring.

Accept it. Again, we just understand that the risk is there and we deal with it. If the risk occurs, we can enhance it. So. That is increasing the impact of the risk. So, say, you know, risk the enrollments faster and we get to get increase the timeline speed up the timeline. So that would be really enhancing and you can enhance and exploit at the same time.

It just really depends again. What’s your risk? What your risk mitigation plans are what your risk tolerances and then or sharing, you can share a positive risk. So this could be something like, if we enroll faster, each site gets a bonus or something like that. I’m not a contract person either. So please don’t use that for anything, but just to say, like, okay, if we get this done quicker, you benefit as well.

So we kind of go through in the document, you’ll see how some options for. Risk contingency planning and what the actions are and what the contingency plans could look like. Again, this is really just a communication tool. This is something that you’re talking about in a team meeting. You’re thinking through what are we going to do if enrollment slow?

What are we going to do if enrollments fast? What are we going to do if the timeline for data entry is not met? Because again, if we’re talking about it early and planning for this, it makes the risk less likely to occur because we have thoughts. And if the risk does occur, we have a plan in place to really help fix that risk or exploited or whatever we need to do, depending upon the risk.

[00:25:02] Alexander: Yeah. And this is, you know, not just an operational thing. I was just thinking about was once working on a phase three study and enrollment was really slow, really slow. Yeah. And we learned that was because of one in exclusion criteria.

[00:25:21] Jess: Yep.

[00:25:23] Alexander: So the yeah, we changed, we changed it. Yeah, it had a dramatic effect on everything.

[00:25:32] Jess: And that’s a perfect example of how risk management is iterative. This is something you’re going to do throughout the life cycle of the study. It’s not just going to be at the beginning when you’re planning, you’re going to have to watch these risks. Which Alex, this is so great. You just keep leading me to the next section, which is so fantastic. It’s like we rehearsed it, but we didn’t the next part is risk reporting.

So, or status reporting. So this is where you’re really looking at the status of those risks. So, like you just said, we noticed that enrollment’s going slower. We need to take action on it. So we escalate that to the study team, or we escalate it and talk about it in, Our next team meeting, whatever it is, so then we think about, okay, what is that?

What was that contingency plan that we said we were going to do if the risk occurs and then we start to activate the contingency plan. So we’ve already thought through what’s going to happen. If this happens, if this occurs, so now we have the plan in place that change management’s going to be so much easier because the team is already aware of what the change would be.

If the risk occurred change management, it can be an entire section in itself because change management is so hard because. People typically don’t like change. We like to do things the way that something says, and oh, my goodness, it usually means an amendment for a protocol. And my goodness, none of us want to deal with that.

Right? So, if we already include these things in the protocol, like that, we’re doing these different, we’re adding in this vendor or whatever it might be. We’re going to take these measures. That’s going to make your change management process so much easier, and it’s going to be able to allow you to pivot and take action as needed rather than having to go through all of this.

You know, all these meetings and all of these approvals. You’ve already done this. You can just keep moving forward.

[00:27:14] Alexander: Yeah, it speeds up things so much. So contingency planning, yeah, it’s risk identification is really a tool to front load stuff. Yeah, and as we all know, if you front load, that’s usually a good investment. We do front loading all the time when it comes to doing analysis. Nobody starts with, you know, analyzing data once the database log is there. Since you know, decades ago, we did this maybe, but not today anymore. And so this is also, it’s in the same. Wave front loading. Yeah. And as you’re planning for all kind of data errors to occur, you also need to plan for all these other things that can have an impact on your study outcome. In terms of quality speed money, all these kind of different things.

[00:28:10] Jess: Absolutely. 100%. And then finally, thinking about this in a lessons learned perspective. Most studies are very similar. Our roles are very similar. So a lot of our risks are going to be the same. On 1 study, they may change a little bit based on, you know, therapeutic area or study phase, something like that.

But really making sure that you utilize lessons learned. This is something that I think that we have so much opportunity to really exploit and develop in clinical research because. In my experience, we don’t really capture lessons learned in a way that really benefits other study teams, or even benefits our study teams as we move forward.

So really capturing those lessons learned to just sit there and think what was the outcome? What did I do? If there was an action so that’s kind of what you do with this. It’s again. It’s a little different than the status reporting 1, but what you’re doing is thinking through. Okay. Did this occur?

And then maybe for your next study, you realize that, oh, you thought that this risk was less likely to occur and then it occurred and it really has to shift your mindset so that you prepare for your next study in a different way. And then that way, you can bring that experience to your other studies to your other projects.

But again, lessons learned is so important and so valuable. And I think that this is an area that we really, really, really need to, take advantage of in clinical research, because right now I don’t feel like we do. And then, of course, lessons learned should be a study. Team event should be a conversation.

I know. Most people, as soon as we get on the study, we’re like, oh, thank goodness. I don’t want to see that study number ever again. But having that last conversation, what did we do? Right? What did we do wrong? What can we learn from this? It’s as simple as that. If you are the city, if you’re the leader in this, you can always start it out with making the risk, sharing that risk chart, everything that we’ve already done.

And you already have all this listed because we’ve already talked about it the whole study long. So you’ve been already identifying the risks as they occur. We’ve been talking about the action plans. We’ve been talking about the outcome. So again, as we’re planning ahead, we are preparing for the future of the study, but also preparing for future studies as well and really setting ourselves up for success.

[00:30:19] Alexander: And this shouldn’t be a finger pointing exercise. Yeah.

[00:30:24] Jess: Absolutely not. Absolutely not. Yes, that is such a good point because this is a team effort. This is never, you know, whenever something wrong happens on a study, very, very rarely. Is it 1 person to blame? It is a team effort for sure.

[00:30:41] Alexander: Yeah. And of course, yeah. As we discussed earlier, there’s a positive and the negative ones. Yeah, so feel free to celebrate a couple of things. Yes, that you actually achieved or risks that you identified and very well managed these kind of things. So it’s not all about, you know, all the bad stuff. It’s also about the good stuff. Yeah.

[00:31:05] Jess: Exactly. Yes. And that’s such a good point. I mean, taking us into, like, the conversation being that really end of study celebration because you made it. Even if there were risks, even if things occurred, you made it, you’re done with the study, right? So there’s not any reason that you should be looking at this from a negative perspective.

This is a celebratory learning activity because we only learn by, you know, Potentially messing things up. That’s the best way to learn. And I think that it’s really a good time to just say, okay, we did this correctly. We didn’t do this correctly. We identified this risk at the beginning, but we didn’t identify this one because again, you want to keep adding risks as they develop or as you identify them.

And again, it’s not a finger pointing exercise. It is not a anything that should be bringing down morale, anything like that. It is really just a learning opportunity to take into consideration what went well, what didn’t and what you can change for your next studies.

[00:32:03] Alexander: There’s a famous quote by my most favorite sports person. That’s Michael Jordan. We talked about how often he lost a game, how often he missed a shot and how often he was given the, you know, the game winning shot and he failed. And then he concludes and says, Oh, I succeeded. Yeah. Yes. Failing over and over and over again, you actually can learn much more from failures and from success.

[00:32:38] Jess: Absolutely. And I feel like everybody, if you most successful people, that is exactly what they’ll say, especially if they’re very self aware, they’ll say that in my failures. I learned the most. And yeah, again, this is not just a 1 person situation. This is a study team X activity exercise. And it really just helps because without doing this, we are at risk of continuing to do.

The things that we did incorrectly the first time. So take 30 minutes. Take an hour and do a lessons learned call and just really think through what went well, what didn’t go well, and but celebrate I any opportunities to celebrate. I think that you need to take ’em. Use this as a celebratory call. Yeah, you can even with some of this, you can have a risk owner who’s looking at the risks and then they that way they own it because studies are so large.

So this again, this is kind of like an overview of risk management, but there are so many other things that you can kind of dive into, especially if you are a project manager and doing more of the higher level project management, rather than just very focused on your, your role in the study. Again, those roles that are very specific are still utilizing project management activities, but there are options if you need to you know, incorporate all the risks of the study and having different risk owners and that kind of thing as well, which again, my contact information is here and I’m happy to discuss that further.

[00:34:02] Alexander: Thanks so much. That was an awesome episode and we walked through all the different steps in terms of risk management from identification, assessment, contingency planning going through the different contingency options looking into status reporting, and of course, doing your lessons learned.

And so thanks so much, Jess. For your final thoughts, what are kind of, is the one key things that a listener should take away from this episode?

[00:34:32] Jess: I’m going to go with, if it’s not written down, it doesn’t exist. And I think that that is because risk management planning, sometimes when things get heated, fingers get pointed. And I think that if you just take the time to really identify your risks in the beginning, and present those to your study team, present those to your management, whatever it might be you’re really able to… Kind of cover yourself if the risks do occur and the individuals chose not to act on those risks.

[00:35:00] Alexander: Thanks so much. Awesome.

[00:35:02] Jess: Awesome. Thank you so much for having me today. This was wonderful to chat with you.

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