MSHS in Clinical Research Administration

[00:13:57.63] So, I want to go through, I want to do a quick agenda so you have an understanding of how everything will work. What I’ll do is I’ll go through and do an introduction of myself, Dr. Butler, and we also have another individual joining us tonight, her name is Shay Brill. Dr. Butler will go through and do a program overview, give you some highlights on that. We’ll then proceed into a curriculum overview to give you a deep dive into some of the content, and then what we’ll also do is we’ll open up the floor at the end for questions and answers.

[00:14:29.13] Do want to take a quick second though, and you may notice there is a chat box towards probably the right side bottom of your screen. As we go through the information, please feel free to go ahead and type any questions in that you may have. What we’ll do is at the end of the presentation, I’ll go through, I will definitely address those questions, but either myself, or Dr. Butler, or Shay will be able to answer those too. So let me go through and do more of a proper introduction of who we are.

[00:14:57.97] So this is me, my name is Kelly Byrne. I am an executive admissions representative for the online programs for the Graduate School for Education and Human Development, and also for the Graduate School of Medicine and Health Sciences. So I’m really excited that we had such a great turnout tonight. And I’m excited to be able to introduce myself as well as our presenters this evening. As far as my experience, I have over 10 years of experience in online admissions, and I definitely helped prepare numerous students both in an online and campus-based program, in starting and graduating school.

[00:15:33.87] My past education, I have a Bachelor’s Degree in Psychology. I do have a Master’s Degree in Curriculum and Instruction. And I also have a Graduate Certificate in Industrial and Organizational Psychology. A bulk of my education was online, so I absolutely know what it’s like to be an online student. But let me go through and do an introduction of Dr. Butler.

[00:15:57.09] So Dr. Butler, she has over 28 years of experience in the pharmaceutical industry, in drug development and clinical trial conduct. She started as CRA then moved into regulatory, and found her passion as a project manager. She co-led multidisciplinary teams to develop new drugs and biologic therapeutics and devices. Hoffmann-La Roche loaned Dr. Butler an FDA in 1993-94 as an industry project manager to help all FDA divisions, as far as implementing the FDA’S team that based manage review process.

[00:16:34.66] So as far as that, she did move in to an executive management position in 2000. As the assistant professor, she started here in 2008. Now the director of clinical research administration programs. Dr. Butler enjoys working with students, teaching, and her research interests include the scholarship of teaching and learning in the online environment, competency-based education, and the professional identity of clinical research professionals. So we’re really excited to have her this evening.

[00:17:04.59] Just want to make sure, can everyone hear me OK? I do have the chat box open, so please let me know. Just want to make sure. OK, good. It looks like we’re able to– hopefully, you can hear me OK. Good. Perfect.

[00:17:23.34] So as far as our other panelist this evening, Shay Brill was recently promoted to create and manage ARG’s newest department, corporate development. Shay joined ARG in 2012, and managed all project staff by evaluating team performance and resourcing needed across the company. She was also responsible for leading quality initiatives and new business processes. In Shay’s newest role, she’ll be creating training programs to help develop new clinical research professionals in the workplace, and supporting employee performance.

[00:17:58.35] Prior to joining ARG, Shay served many roles in a large CRO, including process improvement with a focus on technology, management of global clinical services, and clinical training. She is certified as a CRA with ACRP, and as a PMP with PMI. She has been a clinical trainer for ACRP since 2003, and was the 2012 chair for the Global Conference Planning Committee. Before clinical research, Shay worked as a medical technologist for outpatient services at the University of Georgia Healthcare.

[00:18:34.95] Her education, she did earned her BS in Medical Terminology from Mary Washington College, and she just recently completed all required coursework for her MSHS In clinical research administration here, at the George Washington University, and will be receiving her degree in 2018. So congratulations, Shay. I want to go ahead and I want to turn this now over to Dr. Butler to go through the program overview. Dr. Butler?

[00:19:02.54] JOAN BUTLER: Thank you, Kelly. I also want to thank Shay Brill for coming and joining us today, so she can give you the student perspective. ARG is the Atlantic Research Group, which is the organization she works for. So I’m going to start and give you some information about the Graduate Clinical Research Administration Program at GW.

[00:19:26.75] First of all, of our courses have been aligned, and what I’m talking about is the curriculum has been aligned, and the course outcomes for all of our courses, with the published clinical research professional competencies, which were issued initially by the joint task force for clinical trial competency and published in 3 clinical research journals. And they’ve recently been updated in this past year, and I was involved in one of the subcommittees with the joint task force.

[00:20:04.25] Our program is fully online. And it’s what I’d like to call an applied program versus a more basic science program, like pharmacology or physiology. And our program is grounded both, of course, in the science and medicine of clinical research, but also with practical skills and knowledge to prepare you to be a leader, and a manager, in clinical research.

[00:20:35.81] Now, throughout this program, students evaluate key concepts and skills and clearly align with the competencies which focus on medicines development, human subjects protection. And we complete, what I like to call, professional assignments. In many of the CRA courses, and also some of the health sciences courses, which I’m going to talk about, and what I mean by a professional assignment is it’s a piece of work that you might actually perform in your workplace.

[00:21:11.48] Our program also has an emphasis on leadership. And I’m going to talk to you about the three leadership courses, which focus on strategic planning, competitive scanning, and how to be a change agent. So that’s it for this slide. Next slide, please, Kelly.

[00:21:32.42] So I just wanted to list in these next two slides what are the expected student learning outcomes. What will the students have learned once they complete the whole Master of Science in Health Sciences program? We do also offer a Clinical Research Certificate with only the CRA courses, but these program outcomes are for all of the courses in the master’s program, which I’ll go over shortly.

[00:22:03.75] So students will be able to demonstrate a solid grasp of the clinical regulatory and business requirements in clinical trial conduct. Also, through the coursework, students will learn how to translate regulatory considerations with the regulations, guidance, the requirements, and also the ethical concepts for patient recruitment, retention, anything having to do with the patient. Also, students will learn to integrate research design principles with scientific medical regulatory and commercial requirements that are really needed in medicines development to develop a new investigational product, a new investigational therapeutic.

[00:22:50.02] Our program mainly focuses on therapeutics versus devices, or in vitro diagnostic. Next slide, please. Lastly, students will examine how to manage risk and ensure quality in clinical trial conduct by applying certain management concepts and training methods, and also to utilize effective leadership and management practices to lead multidisciplinary teams, but also to effectively lead projects to completion by applying critical thinking, project management, and problem-solving skill sets. Next slide, please.

[00:23:32.33] So, I’m briefly going to go over our curriculum. So, students will take two eight-week courses in each semester. There’s a session A and a session B. Session A is when you would take the CRA course and then session B is the health sciences course. Between the two courses, there might be a couple of days in Boiling Spring to a week in the summer. In each of the CRA courses there are really three major assignments, to written assignments and discussion board, and there may be other assessments.

[00:24:10.90] So briefly, the first course that students take in the program is CRA 6201, Critical Analysis in Clinical Research. This course sets the student up to succeed academically, as well as laying the foundation, or actually it might be a refresher, on the major concepts in drug development from discovery to the end of phase three. And also major development concepts, such as benefit risk assessment.

[00:24:42.28] In this course, the two major assignments are mainly academic and scaffolded, that means they build on each other. So the first assignment is an annotated bibliography, where you’re doing research, analysis, and demonstrating critical thinking. And then you use that research, as well as some additional research, to prepare an executive memorandum, where you take a position on a particular topic, you present your arguments, your recommendations for whatever position you take, and then you conclude with your takeaway or key messages.

[00:25:22.92] CRA 6203, Partnerships With Human Subjects, is what I typically call our patient centric course. Students examine the various activities focused on the study participant, including subject recruitment and retention, dealing with the vulnerable populations, and we also explore therapeutic misconception versus clinical equipoise. Again, there are some professional assignments such as preparing pieces of a patient education plan.

[00:25:53.53] CRA 6204, The Clinical Research Industry, focuses on the business aspects of clinical research and project management practices, including root-cause analysis, and leading and managing multidisciplinary teams, and some of the team dynamics by examining decision making models, meeting management, and cultural competency. And in this course, it’s based on problem-based learning, where students actually will work through a case study. For at least one of these courses, because we are limited in time, I also wanted to have Shay just give you the student perspective on one of our courses. So Shay, would you like to say something?

[00:26:39.84] SHAY BRILL: Yes. Thank you, Professor Butler. It’s so exciting to talk to each of you tonight. I really wanted to give you a bit more example on the clinical research industry. Because I’ve been in the contract research organization for most of my career, I found this class quite exciting, because the assignments that we had to be involved with were real live examples around a case study, that I can absolutely tell you from my experience would be exactly what you’d be doing in a company my size or larger, when evaluating a clinical project, and actually evaluating the enrollment strategy that had been put forward.

[00:27:22.33] I will tell you already, it was not meeting its target, and how you would assess what to do going forward with meeting those enrollment goals. You had to look at the regulatory requirements in many different countries, the clinical aspect of what that would mean by being delayed in meeting that enrollment goal, and then the financial impacts of the requirements of that project. That would be one of the assignments.

[00:27:51.96] And then upon building on that, there’s also the second assignment that came about with team performance. And this team was individuals from all aspects of data management, clinical operations, and looking across that in many different countries, which I think provided a great example, in the class that I was in, in being able to showcase what you would have been doing in a real world example. So I hope that helps to give you a little bit more perspective of this particular class and being able to translate, not only what you are going to be doing in the classroom setting, but I can promise you would also fulfill your goals working in a sponsor company or even an CRO organization, like the one on in.

[00:28:39.41] JOAN BUTLER: Thanks, Shay. So I’m going to continue now with the next course, which is CRA 6209, Quality And Risk Management, which is one of our more advanced courses, building on some of the concepts that students have already learned, and focuses on ensuring quality to manage risks during clinical trial conduct using quality by design as a model, for the first half of the course. And then the second half focuses on safety risk management, which it focuses from the beginning of development, starting with preclinical studies and risk assessments there, through post-marketing surveillance.

[00:29:23.78] Our next course is CRA 6202, Medicines Development, which is another more advanced course. And this is where students examine various activities and decision-making that must occur when one is in a pharmaceutical company developing a new therapeutic or actually working in a CRO. And it gives you a perspective if you’re working on the site side as well, about what’s happening and how you are contributing to the sponsored pharmaceutical company.

[00:29:55.88] So this course mimics how a pharmaceutical company might develop a new therapeutic starting with assessing the competitor’s labeling, if it is a product where there are other competitors, evaluating initial safety, moving from the different phases, and developing an adequate benefit efficacy and safety pool, so that you can adequately assess benefit risk. And this course also does examine post marketing activities, which include lifecycle management types of strategies.

[00:30:33.80] Now, in the CRA core curriculum students choose one of these two electives. The first is CRA 6208, International Clinical Research, where the students evaluate key strategic regulatory and operational aspects of conducting a global trial in various regions or countries around the world, obviously. Or the second one is CRA 6211, Monitoring, Auditing, And Oversight In Clinical Research, which focuses on monitoring. Clearly risk-based monitoring is examine the role of a QA audit and the importance of a QA audit versus what is clinical oversight in clinical trial conduct functions. So these courses would comprise a Graduate CRA Certificate.

[00:31:30.59] Now I’m going to switch to the next slide, please, Kelly. Now, these are our health sciences courses. So each of these courses are taken in session B. These are not in the order that they are, but I’ll try to link them in. So in terms of the first course, which is actually taken in the third semester, it’s HSCI 6263, and I just want to say with the health sciences courses, your students are mixed in with other graduate students from regulatory and health care quality. Two other graduate master’s programs in our department of clinical research and leadership, whereas the CRA courses are predominantly CRA majors.

[00:32:15.55] So in biostatistics, this course provides an introduction to the foundation of biostatistics, which is comprised of the design and analysis of clinical trials, and topics can include distributions, populations, sample selection, hypothesis formulation, T-tests, analysis of variance, chi-square analysis. And students examine and output from a statistical software, typically SaaS, which is what is used in the pharmaceutical industry, and practice problems and review scientific literature, so that you have a good understanding of how to apply statistics in clinically and translational research.

[00:32:59.48] The second course, which is actually in the second semester, is Epidemiology For Clinical And Translational Research. And of course, this is an epidemiology course. And epidemiology is a study of the distribution and determinants of health related events within a given population. So in this course you use descriptive studies, surveillance, and analytical studies. You’ll explore public health factors, risk factors, being able to identify risk factors and health disparities of disease. And you also explore basic concepts and methods of epidemiology, and their application in measuring, studying, and improving the health of populations. And how epidemiological practices are applied in clinical research and translational research.

[00:33:54.28] Now the next three courses are strategic leadership courses. HSCI, Health Sciences 6223, is Topics In Healthcare Leadership. And this is actually in the first semester, you take CRA 6201, and then this course. And in this course, you would explore the major conceptualizations of leadership to develop your own definition of leadership, and how leadership functions within an organization. So just to give you an idea of some of the major assignments, and they do change, might be a reflection journal, where you could be free to write your own thoughts and also really explore leadership concepts to help you develop your own leadership style; an action coaching project; and a final integration paper on your own conceptualization of leadership.

[00:34:49.12] HSCI 6240, Issues And Trends In Health Systems, is where you would analyze the structure and organization of the US Healthcare system, including policy development at the federal, state, and local levels, and see how these policies apply and impact clinical research. You are encouraged to compare and contrast current and emerging health policy issues, including legal, ethical, and bio-ethical concepts. And in this course, you formulate a policy analysis on one specific issue within the cost quality access model to influence and improve a healthcare system. And we have had students who have worked on papers and they’ve actually been able to publish them.

[00:35:42.82] HSCI 6241, The Healthcare Enterprise, is what I call the strategic planning course. And this is a course which challenges you to integrate the strategic and operational components of a clinical research organization, or the organization you work in, I’m assuming it’s clinical research, but it might be a little bit different. And what you create is something that is typically created in business scenarios, the performance dashboard or scorecard, and there’s a lot of literature out there about that, where you would evaluate performance on key attributes, service, people, finance, quality, and growth.

[00:36:24.01] Now, our last course, which we call the capstone course is where you really integrating many of the concepts that you’ve learned within the program, but you also integrating, possibly, something about your own organization, because we want you to apply the principles from HSCI 6241, the strategic leadership course, and also I always tell students keep all of your work from HSCI 6223, because it will come in handy in this course. You’ll also learn about the academic change literature. And the big assignment here, there are two. They also scaffold. You’ll do a literature review to inform your change management PowerPoint presentation.

[00:37:16.72] And here, students will develop a proposal, which is unique to the needs of– we like them to use your own organization or an organization of interest, and you identify a change based on one of the metrics that you’ve identified in your balanced scorecard from HSCI 6241. And then part of the presentation is talking about how you will implement your change. How you will lead the change, because it’s very important, and I firmly believe it’s important for leaders to be able to, one, adapt to change, but also lead change in organizations. It’s a big part of it. In my time as an industry I co-led, with many other people, change initiatives. So with that, I’m going to turn it back to Kelly.

[00:38:12.87] KELLY BYRNE: Hi, everyone. Thank you so much. No, thank you so much, Dr. Butler and Shay, for sharing all that great information with us. So I want to go ahead and I absolutely want to open up the floor for any questions. I did see several questions coming through already, so I’m really excited to be able to share this with you. It looks like a couple of questions. So the first question that we have, I think, is more directed to Shay. Shay, it’s nice to hear from a recent graduate. Would you describe a project or assignment that you worked on that you would consider a favorite or very impactful?

[00:38:50.37] SHAY BRILL: Yeah. I’d be glad to describe a couple of them. One of the examples that I’m going to give you tonight is about the example of, I had never had to write an opinion editorial. And it was an opportunity for me to be able to put together my thoughts and ideas about an issue in healthcare, be able to take the time to research that, and really go through an examination of the cost and expenses that we incur in the last years of our life.

[00:39:23.25] I had just recently had my father pass away two years ago and experienced that firsthand, and so by studying the healthcare industry, which I had not had an opportunity to do in the many years of working with a contract research organization. I had that opportunity. And was able to publish a opinion piece in my local newspaper, where my family is quite well-known, and put out there that exposure and experience of how much it costs, and many people actually came up to me when I went back home to visit my mom, saying how much they appreciated the consideration that went into that. And I would not have been able to do that, or had that opportunity, if I had not been a part of this program.

[00:40:09.39] Another example that I’d like to give, which is more in the space that I’m very comfortable with, would be giving a presentation or a video about the regulatory requirements in a given country. I was actually assigned South Africa in the class for the clinical research industry. And I had to put together some of the limitations of doing research in South Africa, as well as some of the advantages of doing that. There was experience that I had had, because I’d been in that country 10 years ago. But the nice thing about this program is that it caused me to re-evaluate how far South Africa had come in their regulatory strategy, and the research they were actually conducting today, beyond just HIV trials, which I was having experience with 10 years ago.

[00:41:04.93] KELLY BYRNE: Thank you so much for sharing that information. That, actually, another question had popped up for you to, Shay. The question is, Shay, on average how much time do you think you spent per week working on the program?

[00:41:18.29] SHAY BRILL: Wonderful question. I really appreciate that. What I found, and I’ll have to say I highlight my time management skills, because being an executive at a small company, I found that my routine, and I’ll give you my own example, is that I would usually finish my day job around 7:00 or eight o’clock at night. And then I would find myself usually working from usually 8:00 to 11:00, on any given evening, reviewing content, writing down notes, and getting ready for what, I would say, that would lead me up to usually Friday, where I would have a discussion board that I would need to post, along with citations, and references for that, because it wasn’t just good enough to say Shay Brill says, I had to find any information that would support my opinions or my thoughts on a given topic.

[00:42:13.57] And then usually what would happen is on Saturday and Sunday, I would spend some time responding back to two or three students in the course that I was in providing them feedback in what they had put together, maybe even challenging some of their comments and some of their thoughts, and then maybe taking a deeper dive on a particular reference that they had, that I had not found during the week, in getting ready for that particular post. Of course, over the eight weeks, there were two, what I would consider to be, larger assignments for each class that I had. And those would take a little bit more time. Those would be times I would find myself working several more hours on a Saturday and Sunday in order to prepare for that assignment. So in any given week, I was working somewhere around 10 to 15 hours in this program.

[00:43:14.82] JOAN BUTLER: And we typically tell students they work on average 15 hours a week, it’s Professor Butler. [LAUGHS]

[00:43:22.71] KELLY BYRNE: Thank you so much for sharing that. I have another question and this, I think, can probably be directed to Dr. Butler. The question is what is the typical background and experience of a qualified candidate for the program?

[00:43:39.14] JOAN BUTLER: So our admissions requirements, there is an undergrad GPA requirement, however, we sometimes do admit students that have a little bit lower GPA, but it’s the whole picture. It’s the whole Gestalt. We admit students who are clinical research professionals or sometimes related experience. In terms of clinical research professionals, in our program, we have many different types of clinical research professionals. We have, first of all, from different stakeholder organizations, from sponsored pharmaceutical companies, CROs, sites, government agencies like NIH, so its various stakeholder organizations.

[00:44:26.69] We have CRAs that are in-house monitors, we might, I consider QA auditors clinical research professionals, data managers. So it really runs the gamut. Most classes it is varied in terms of job roles and also experience. We do admit students with some related experience, but I tell people who are interested in the program, you have to know the basic clinical research foundational concepts, because this program is not to teach newbies about clinical research, you have to understand, you have to know about the different phases of development and what they mean. You have to know about human subjects protection, what informed consent is, what a protocol is. You have to understand about what is safety and efficacy, just basic foundational concepts.

[00:45:23.81] So we don’t require a certain amount of time, in terms of if you are a clinical research professional. Typically, our admits might have a year up to 15 years. I mean, it does run the gamut. We have admitted students with related experience, such as in public health, for example, because they do health services studies a little bit different from biomedical or clinical trials, that clinical research professionals do, but they understand the foundational concepts.

[00:45:59.84] KELLY BYRNE: OK. Thank you so much for sharing that information. So another question is structure of the program, and I can answer this. The question is how many classes per term do students typically take? And I know she went into a little bit about her experience with some of the courses, but also some of the projects that she’s worked on. But typically, our students take one course at a time. Oh, and actually, this prompted another question. Do you have a situation where students have taken more than one course at a time? Dr. Butler, I don’t know, did you want to respond to that one?

[00:46:35.62] JOAN BUTLER: So just to finish, students take two courses a semester sequentially, as Kelly has mentioned. And fall and spring are required, summer is optional, but if students want to get their master’s in two, years they go two courses every semester, fall, spring, summer. We really don’t recommend students taking more than one course at a time. However, we have had students, and it’s limited, it’s very limited, who are not working. Students who are working, I don’t think you really have the time. But we have had students who either are working part-time, or maybe they’re just not working for whatever reason. And then some students have taken two at a time. And this, meaning in session A and/or session B.

[00:47:37.55] KELLY BYRNE: OK, thank you for answering that. Right. And I know when I’m speaking with students, I always recommend definitely starting with the traditional course, and that would be one course for eight weeks, that would be A, and then one course for eight weeks, that would be B. So to Dr. Butler’s point, even though you’re taking two courses over that semester, that session, you’re not taking them simultaneously. You’re taking one class, and then one class favor A session and your B session. So hopefully that helps to clarify your question. Thank you.

[00:48:10.58] Another question as well is this is a question regarding transfer credit, so this individual has a question because she has some credits from a certificate program that she took in clinical research conduct and management. So as far as transfer credit, I know that we’ll definitely take a look at transcripts, but Dr. Butler I don’t know if you wanted to add anything to that regarding transfer credit into the degree.

[00:48:40.10] JOAN BUTLER: Sure. GW has a university policy. I know it’s at least two, it may be three. But there’s a review process. So the courses have to be applicable to the program and to the learning outcomes. If a student has applied, we will obviously have their transcript, but a student has to submit a full syllabus of the course that they want to transfer in, so we have a good idea of what the content is, meaning the syllabus should be including a course overview of what each week provides and some of the assignments, so we have a good idea of what that course contains in terms of the curriculum.

[00:49:30.47] There is a review process through the program, you work with our advisor, and she’ll put together the paperwork, and I’ll review it, or for example, let’s say you take an epidemiology or biostatistics, then I would kick that over to the course director for the research courses, and they would review that syllabus to see if it’s applicable. If it’s applicable, you have to complete a form for transfer credits, you submit the form, and then you get those transfer credits, so you don’t have to take the course, and you, obviously, get the transfer credits. And it’s at least six, but I believe it’s nine now. I think they recently changed the policy. So it’s definitely six, it could be up to nine.

[00:50:17.91] KELLY BYRNE: OK thank you so much. I do have a question here and this is a really great question regarding previous educational background. Is there any particular undergraduate education that you’re looking for, such as chemistry, biology, clinical research? Dr. Butler, if you want to talk about that, that would be great.

[00:50:40.61] JOAN BUTLER: The short answer is no. [LAUGHS] And I used to work in the industry. And different companies have different philosophies, but I know in the 90s there was a shortage of CRAs, a real shortage. There’s always a shortage, but there was a real shortage. So companies were hiring from all different backgrounds, communications, anything. The typical background is a science background, biology, of course, healthcare professionals, there are some nurses that go into clinical research. But there is no requirement for a particular undergrad degree that comes into the program. But it is good if you have experience as a clinical research professional. And I think for those working clinical research professionals you know there are clinical research professionals that have psychology backgrounds. I’ve seen a lot of people who have psychology backgrounds, some communications, of course, the sciences, immunology or biology, but it’s not a requirement.

[00:51:48.05] KELLY BYRNE: OK, thank you so much. I have another question here, and I can take this one. It’s just a question regarding how long the program typically takes to complete. Typically, if students are taking the one course at a time for eight weeks. I would say on average usually students are done within about two years, it is a 36 credit hour program. So hopefully that answers your question. Here’s a another great question. So the question is how many students are typically in an online course? And is the program only offered online?

[00:52:23.07] JOAN BUTLER: That is a good. First of all, these all have been good questions. So this program is a fully online program. Although, for example, with discussion board, you do have to enter, like I set up my discussion boards Friday to Sunday, you never have to be online for a particular time and day. We do offer optional collaborate sessions, which are recorded, which are real time. I do that for my courses to talk about assignments or whatever. But again, they’re recorded. And then, what was the other question?

[00:53:01.20] KELLY BYRNE: Yeah, absolutely. So the question was how many students are typically in a class?

[00:53:06.14] JOAN BUTLER: Oh, yeah. OK.

[00:53:06.70] KELLY BYRNE: Yep.

[00:53:07.02] JOAN BUTLER: So yeah. So our typical cap is 15 students per section of a course. And sometimes it might be a little less, it really depends on the enrollment that semester. There are cases where there might be more than 15, and then if my faculty, and they’re all for the CRA courses experienced clinical research professionals, I have some faculty who love to teach. I have one person who loves to teach CRA 6209, very experienced. And what he likes to do is he will teach more than 15 students, but what he does is, he divides them into groups. And so there are two separate groups of, let’s say, 10 students each. And those students all have the same curriculum, but their discussion boards are only a group of 10. We do cap it at 15 usually, because we found for a faculty to do a good job on managing the discussion board, it’s hard to do with more than 15. Sometimes faculty will do a little more, but we do try to keep it at 15 or less.

[00:54:31.65] KELLY BYRNE: OK. Thank you.

[00:54:33.38] SHAY BRILL: Professor Butler?

[00:54:34.43] JOAN BUTLER: Yes.

[00:54:34.94] SHAY BRILL: Would you mind if I add to that?

[00:54:36.92] JOAN BUTLER: Yes, please do.

[00:54:39.89] SHAY BRILL: Because of my age, of course, this is my first time doing an online program. Everything that I experienced before that, undergrad, was in person. I had done a few webinars certainly throughout my course in a professional manner, but never committed to two years of being in an online program. I’d like to encourage everyone that what I really liked about this is that if I had not done an online program, I could have never guaranteed with my travel, my need to be in different places all across the globe, a commitment to being at George Washington on a particular day at a particular time. I couldn’t have been able to do that. And we have several people in my company that are traveling CRAs that could have not been able to do that either.

[00:55:33.29] What I liked is that the flexibility that this gave me is that on any given day, I could decide when I was going to work on my course, and my assignments, and do my reviews. I also had the luxury of being able to see what every student, along with myself, was taking away from that reading material. So I wasn’t missing a conversation, because everybody was going on to the discussion boards and typing up what their opinions and thoughts were with the content that we were viewing. And I really liked that, because I felt like I got a better experience, not only from what I was seeing, but also the interesting part every week was taking the same material and seeing what someone else’s perspective was from reviewing that. And I really appreciate the online flexibility.

[00:56:25.82] I did not have any technology issues. I was always able to get connected. And many times I was not connecting every night, I had the materials with me, I could review them any time. And then from time-to-time, it was looking at a video or those sorts of situations. So the online thought scared me at first, but as I got into it I found that it gave me flexibility to work on it in the morning, or in the evening time, or at a break during the day. So I just wanted to add that opportunity for everyone else that might be worried being online makes them nervous.

[00:57:04.46] KELLY BYRNE: Thank you. That was very helpful, Shay. I’m sure there’s a lot of people who, and I know just with talking with people on a daily basis, there’s a lot of individuals who have never taken an online course before, maybe have graduated from their undergrad years ago, so of course, everyone’s a little nervous. Especially, kind of fear of the unknown. I was going back to school myself, I mean, years after my undergrad, and I decided to pursue my master’s degree online. And of course, I was a little nervous as well, but to Shay’s point, I loved the flexibility of it. I loved the benefit of being able to really see how others with maybe similar experiences as me professionally, but they’d be a little bit differently, like how they were able to incorporate the information and what their experiences were like as well.

[00:57:49.01] And it’s one question I always get too, is how interactive are your online courses going to be? And I do, I feel that you really get a lot from being able to interact with your classmates, and of course, at the convenience of your time as well. So, I do have a question, will this session be recorded? Absolutely. This session will be recorded. We will ensure that we send out the recording to all of the attendees this evening, so that way you can review it again as many times as you want to.

[00:58:18.49] Let’s see. And it looks like– Oh! OK. I do have a really good question. OK, so the question is if the program is asynchronous, and there is not a set time to be logged in, how would I be able to view lectures, material? OK. This is a great question. I think they’re looking for more information on additional content that we would provide, or I guess, maybe, what their experience would be like as an online student. So I don’t know, Dr. Butler, or Shay, if you want to add any additional information about that? That would be great.

[00:58:55.04] JOAN BUTLER: Well, I’m going to start, and then Shay may be able to add more. Just so that you understand the format, so our program is built on a learning management system that online training, if you have online training or taken it, is built on. So it’s a learning management system called Blackboard, which is used in other universities and colleges.

[00:59:20.06] The coursework, the curriculum, for every course, at least for the CRA courses, and they’re also laid out pretty similarly for the health sciences courses, is it’s online. It’s asynchronous, but you can go in at any time. So you go into the course, there are buttons where you navigate on the left margin, it opens to an announcement page, and those are announcements for every student. Then you click in, you see the syllabus on another page. Then the way we set up our courses is by weekly sessions. Every course is eight weeks, so there’s a session for each week. Week one through week eight.

[00:59:59.48] So you click into the weekly session, you see in the syllabus are the course objectives, in the weekly sessions it starts out with the weekly objectives, which builds up to the course objectives. Then it’s some type of overview. It could be a narrated PowerPoint, it could be text, but there’s an overview of the content of the particular topic for that weekly session. And then next comes readings and resources. That’s where you’ll get your readings that you can download, or they might be web links. For example, we also use some materials from FDA.gov, which, obviously, you could go to FDA.gov, but we provide you with the links.

[01:00:43.07] There also might be some websites. And they also, particularly in the CRA 6204 course, some practical business articles about project management, or whatever. But otherwise, the literature is evidence-based from peer-reviewed journals. So again, there’s the overview, the readings and resources, and then the assignments. And that’s where what’s listed is what’s due that week. It could be a discussion board, it could be a written assignment. Only the assignment is written there.

[01:01:16.70] On a different web page or learning management section is the discussion board, so you click in there. And also there’s another place for the two major assignments, which explains every detail about what’s required for the assignment, and also the grading rubric, how you’re going to be graded on it, and the submission link. So you actually submit your assignment through the link. And lastly, then you have a grade center portal. That’s where you’ll see all the assignments and your grades listed. And there are some resources, there’s also some technology resources in the courses. Shay, you have anything to add from a student perspective?

[01:02:02.08] SHAY BRILL: I just want to reassure everyone that what you have and what Professor Butler has reviewed is really, and I literally took it week, by week, by week. I could absolutely see what I needed to do on a given week. I’m looking at an assignment right now that would have been due on Wednesday, and my discussion board would have taken me through it on Sunday. I knew when my bigger assignments were coming up and being able to understand what they were. So this was laid out all at the very beginning. And classically, the first week was some reading that you would have to do and introductions that would be needed. And then it would often build upon that up to the last eight weeks.

[01:02:45.65] I really enjoyed the fact that I could see what my week was going to have. And from time-to-time, as you can always imagine, either personal requirements came in that I needed to take care of or my business, and my day job would take over, and there were times I would have to ask for extensions. And my professors were always accommodating with that, they would understand. I’d ask for, sometimes, an extension, and they would grant that.

[01:03:17.50] And I want you to know, over the course of the two years, that will probably happen to you as well, that you’ll have to ask for that kind of extension. And the professors were absolutely very understanding in what you were able to do, and really trying to make the best accommodations for you to complete this. So the professors, I felt like, were totally behind your success in completing what you could and understanding real world examples when you would find some weeks a little bit more challenging than others.

[01:03:50.03] JOAN BUTLER: That’s right. And every course has of course overview that lists all the assignments and due-dates.

[01:03:57.38] KELLY BYRNE: OK. Thank you. And that actually prompted another question, do classes require textbooks, or are we only responsible for the readings posted to Blackboard?

[01:04:08.62] JOAN BUTLER: So for the CRA courses, because those are what I’m ultimately responsible for, there are very few textbooks, because what we found is that textbooks, there’s a model, as soon as the textbook’s published it’s out of date. So [LAUGHS] we supply the readings in each of the courses. There is a short, a small book in CRA 6203 that we ask you to purchase, because it’s the only book we found with that particular content, but we also are mindful of the expense.

[01:04:50.56] But to that point, and I think Shay’s also mentioned this, you will be required to conduct some of your own research. We have Himmelfarb Library, which is totally online. They have online information people to help you. Because your assignments, not all of them it depends on the assignments, they might require you to find articles to support what you’re saying. So for the course readings, we supply them all, but for some of your assignments you may have to do some of your own research. And you could do it through Himmelfarb, which has access through Google. If you like using Google, you can use Google Scholar through the Himmelfarb, but then you can click on the– if Himmelfarb has it, it comes up through that search.

[01:05:45.58] SHAY BRILL: Professor Butler, I also will tell you my own experience when there were textbooks involved, each one of them I could get on Amazon Prime, and have them delivered to my home within two days. So I absolutely knew going into a course whether that book was available to me, or if I needed to buy it, and like I said, and promoting my own membership to Amazon Prime I found it very easily to get those books through Amazon Prime and have them delivered in two days, so I didn’t find that to be an issue. But most classes the readings were already provided. And then I didn’t purchase many textbooks at all over the course of the two years.

[01:06:29.80] JOAN BUTLER: So Shay, you probably are in a better position, I think for epi and biostats, in one of those courses is there a book? Or both of them?

[01:06:41.65] SHAY BRILL: Yes. I remember, because this was my first stats course, everything that I had learned about stats were from our personal statisticians at the two companies I’ve worked for. I did end up buying that book, because I found it to be a great reference and a tool for me in the future. And then, there was a leadership book from Northhouse that I ended up purchasing, because it basically provided a hundred years worth of information about the leadership models that have been created throughout history, and I found that to be quite interesting as well. So there were two classes that I ended up really wanting to have more information about. And really for my own reference library in the future.

[01:07:31.83] JOAN BUTLER: Thank you.

[01:07:33.76] KELLY BYRNE: OK, fantastic. Thank you. So there is a question regarding financial assistance. And I can answer that. So we do have a lot of students who inquire about utilizing financial aid, typically applying through the FAFSA, which is the Free Application for Federal Student Aid. I know with a master’s degree, absolutely, whatever it is that you qualify for you can use. But that could be an option if it’s something that you’re interested in applying for. Of course, there’s specifications on it. There’s requirements on what you can qualify for. I would advise you, if you’re interested in it, go ahead and apply for it. That way the financial aid office can give you a better understanding of what it is that you would be eligible for, but that’s a fantastic question.

[01:08:19.78] Oh, I do have another question regarding next session. Oh, OK. So this is a great question. The question is you had mentioned, there’s an A session and a B session. Does that mean that we can start in either term if we decide to pursue the program? I can answer that question. So typically, we would suggest applying for the A session, and what I mean by that is there’s usually three terms the year that we have incoming students for. The next session would be the April 30 session, and then after that would be the fall session. So hopefully that answers your question. I mean, anything else on that one, Dr. Butler?

[01:09:03.42] JOAN BUTLER: Well, I do recommend that you start with section A for your first semester, because we crafted the first course, CRA 6201, to develop or reinforce the academic skill sets that students are going to need to be successful in the program. So I really recommend, and I strongly recommend, that students start with session A for the CRA program.

[01:09:30.83] KELLY BYRNE: Mm-hmm. Right. Right. Absolutely. So and again, the next session would be the April 30 session, we are still accepting applicants for that term, so if you are interested I would highly recommend reaching out to the admissions office that way they can talk with you on an individual basis, answer any questions that you have, really make sure that you understand the application process and what would be needed to complete a quality file. The number is listed at the bottom. It’s the 844-386-7323 number.

[01:10:07.83] Oh, great question, a question on office hours. So typically, there’s somebody here usually Monday through Thursday until about 8:00 PM Eastern. Friday, we’re usually in the office till about 5:00, but there’s always somebody here probably from about 9:00 AM until about 2:00, 3:00 PM on Saturday. So we are available. Again, I mean, reach out if this is something that you’re interested in applying for that way we can address any questions, concerns that you may have, and of course, help you build a great quality file to hopefully gain acceptance into the program. So those were very good questions. I do have another question here too. So another question is regarding the applicants again. So it says, her question is, do most students who complete the program work mainly in clinical administration? And you could address that if you wanted to, Dr. Butler.

[01:11:11.14] JOAN BUTLER: Well, clinical administration, that’s very broad. Again, we have students that come from different job roles. We actually have had some students apply that are not working at that point, or they’re taking a break for whatever personal reasons. We have had some students, in various job roles, whether it’s a CRA, directors of operations, so it really runs the gamut. We’ve had independent consultants who are running their own companies. So we focus on clinical trial conduct in an administration, but we also focus on drug development. So when you say administration, I may define it a little bit differently than you do. But so they’re in various job roles.

[01:12:10.71] KELLY BYRNE: Definitely. Right. Right. I feel the same way, it’s very broad when you think clinical administration, so there’s so many different positions. But yeah. I have another question here too. So this goes back to– Let’s see. Oh, OK, so the question is, how many students are accepted each term? I think, from my experience with it, I think, it varies. It varies by how many applicants we have. Dr. Butler, if you wanted to answer the question, that would be great, if you have more guidance on that?

[01:12:46.77] JOAN BUTLER: Well, Kelly, of course, we work together.

[01:12:49.68] KELLY BYRNE: Right.

[01:12:49.98] JOAN BUTLER: So you’re–

[01:12:50.74] [KELLY BYRNE LAUGHS]

[01:12:51.25] –absolutely right. There is no cap. There’s no market and then we stop. So it really depends on how many are applying and their qualifications, and the numbers vary actually each semester. And we do admit students for fall, spring, and summer.

[01:13:18.03] KELLY BYRNE: Great. OK. And then I’m just making sure that I’m not missing any additional questions here. A lot of fantastic questions came through tonight. Thank you so much for your interaction, all the attendees. I mean, it looks like there was a lot that came through. And I love that we were able to answer those questions. There was a lot of duplicate questions that came through, so it was great that we were able to address really all of them.

[01:13:42.75] So let’s see. Let’s see. Yeah, I’m not seeing anything else that wasn’t already addressed. Oh! Here’s a great question. One more actually that has come through recently. So how long do I have if I start the program to complete the program? I realize typical students take two years to complete the program, however, if I need to take a term off, would that be OK?

[01:14:10.21] JOAN BUTLER: So I think GW’s policy is you should finish within seven years the latest. However, with that said, in terms of what you’re allowed to take off, students are allowed to take two leaves of absence for a semester. And also summer is optional, remember. So let’s say, you just want to go fall, spring, fall, spring then you would finish in three years, as an example. But again, students are allowed to take two leaves of absences, which means two semesters off, and summer is optional. So students want to finish rapidly, then they go through it and finish in two years, but students are allowed to take a break, and I believe it’s a university policy that you have to finish within seven years. But if you only take– But typically students will finish anywhere from two to three and a half years.

[01:15:19.74] KELLY BYRNE: OK, thank you so much. Oh, just one other question. I think she’s just looking for some clarification. So her question is, what happens if, say I’m the 18th most qualified candidate out for review, does that mean I don’t have a place and I have to decline to the next term? I think, maybe, her question is surrounding how many people are typically in a class, and how the class–

[01:15:46.53] JOAN BUTLER: Oh, I see.

[01:15:46.71] KELLY BYRNE: –is run. Right. I think, she’s just a little concerned. Right.

[01:15:50.97] JOAN BUTLER: No, that’s a very thoughtful question. So again, we admit students it really depends on enrollment. I can tell you, I can share with you, for example, we admitted a lot of students for spring. So we actually ran three sections of CRA 6201. Because I hire faculty, again, they’re all experienced clinical research professionals, people who want to teach, but sometimes there’s more than one instructor running a separate section. And that’s how we handle the amount of students that are admitted.

[01:16:37.10] KELLY BYRNE: OK, thank you. Yeah, I think that answers her question. Another great question. And it looks like– I don’t see too many more– Oh, yeah she says, thank you. [LAUGHS] So it doesn’t look like there’s too many other questions coming through, I mean, it looks like they’ve all been addressed from previous questions that were asked. Let’s see. Yeah, I mean, as we’re wrapping up tonight, I don’t know if you have any closing thoughts, or any other advice, or suggestions that either you, Dr. Butler, or Shay, maybe you want to share with the individuals that attended tonight?

[01:17:16.70] JOAN BUTLER: Well, first of all, I want to thank you, Kelly, for organizing this. I want to thank all the attendees for taking the time out of your evening, I know we are all busy. And Shay, I really do appreciate, you just graduated from the program, but you came and you took the time to give back to the program, but also to prospective students. And so thank you very much.

[01:17:43.19] KELLY BYRNE: OK, thank you so much. Yeah, oh, sorry. Go ahead, Shay.

[01:17:46.25] SHAY BRILL: No, I was just going to say absolutely. It’s so exciting to be– certainly. I started the program in January of 2016, I went the spring, summer, and fall sessions for the two years. I also had some great recommendations from other individuals that I highly respect that are right now in a position of being a director of project management and a director of quality assurance, both that CROs, Contract Research Organizations. So I know the program comes highly recommended. I’ve enjoyed my experience and I certainly think it continues to improve our industry to being clinical research professionals, so I think those are my closing statements and comments. And I really appreciate the faculty that they have involved, because these are certainly experts in the industry providing their perspective and overview of your education as you go through this program.

[01:18:50.27] KELLY BYRNE: OK. Thank you so much. So again, if anyone has any further questions, I mean, feel free, reach out to the admissions office. We would love to be able to assist you and really talk through options for you. Talk about terms coming up, when is going to be a good time for you and so forth. The number is listed at the bottom. It’s the, 844-386-7323. I do understand we ran over just a little bit tonight, but I appreciate everyone still in attendance, and hopefully, you were able to find a lot of the questions, the responses, very beneficial.

[01:19:25.80] Other than that, yeah, I mean, I definitely look forward to speaking with all of you eventually, but want to concludes tonight’s presentation. Thank you again, Dr. Butler and Shay for providing some fantastic insight tonight, answering all the questions for potential candidates as well. And other than that, everyone have a great evening. I look forward to speaking with you soon.