Table 3.

Specific Examples of the 12 Success Characteristics

Success Characteristic	No. of Centers*	Examples of How this Characteristic was Met	Key Demonstrative Quotes
Leadership with Clinical Research as a Priority	9	• Single highly motivated, engaged PI (either adult or pediatric) • Shared leadership between multiple engaged PIs (both adult and pediatric) • Shared leadership between the PI(s) and the research coordinator or manager	“The heart of our program is the very strong leadership of the Pediatric PI and the Adult PI. Really, without them we would have maintained the status quo.” “If I had to say who has the greatest influence on our team, I would have to say both the Pediatric PI and the Research Manager.” “He (PI) is very hands-on. He’ll sit down with us rather than working us to death and say, ‘Let’s re-evaluate, what can we do to get through this, how can I help you?’ He really makes this a great job.”
Adequate Staff	9	• Recruit good staff looking for team player, problem-solving skills, attention to detail, self-motivation, and good fit with the rest of the team • Enough staff for the work: monitor workload and hire or improve processes (i.e., create efficiencies) such that the existing staff can perform the work • Focus on retention by providing opportunities for growth	“I think you can have the best job descriptions and all the funding you need, but if you don’t get good people it’s a non-starter. And it’s a certain type of person…the people that work in our program are all self-starters who you don’t need to tell what to do.” “When I interviewed her…her energy and how quickly she learns things were so apparent to me, and it didn’t take long for her to make key contributions to our group.” “You can’t be like the kid in the candy shop and just keep going….you have to know when the staff is at their limit.”
Effective Communication	9	• Regular research team meetings (adult and pediatric staff) • Research staff attend clinical care meetings • Research staff share office space with clinical colleagues • Adult and pediatric research teams share office space • Responsiveness and clear communication of expectations	“There is just great communication. Beyond the communication about who is coming in and might be eligible for a study, the research team does an outstanding job of communication with us if there is a clinical issue that they notice during a research visit. We will often hear about changes in labs or lung function. There is just a great interchange of information.” “The more you communicate with the sponsors and the quicker you get things back to them, the quicker they’re going to get things back to you. The only way that I can do submissions so quickly is because I call them and say, ‘I am willing to give you my full attention for the next day and get this done for you, but here is what I need from you.”
Customer Service	8	• Study visits scheduled at odd times of the day and on weekends • Attention paid to the comfort and convenience of the study subjects	“The coordinators just have that attitude…’oh we will make it work—we will find you a place to stay when you’re in town, we will get you a gas card if that’s a problem.’ The subject feels valued and that they are important.” “We really coddle our subjects. The coordinators are just so flexible with them…. We’ll come in at night, we’ll do stuff on the weekends, just do the best we can to accommodate their schedules.” “We really make an effort to see these people when they are not participating in studies, which I think they really appreciate because we see them as people, not just research participants.”
Culture of Research	8	• Considered a shared responsibility for clinical care and research teams • Observational studies offered to subjects when young • Research team members attend all CF clinics to meet patients, talk about research in general or about specific studies	“Historically, no one was really approaching the families…it just wasn’t part of the fabric of the center. I give credit to the Pediatric and Adult PIs, because that has visibly changed here. Families now know and understand that we do research here.” “Even before we had the Port CF registry, we had a consent form for an in-house CF database. That consent form gives permission to put their data in the database, but also gets permission to have their data reviewed for potential eligibility for studies. So it is right up front that research is part of the culture here.”
Continuous Process Improvement Driven by the CF Research Team	6	• CF team approached institutional offices to work on reducing time for key milestones (IRB or contract approval) • Fixing problems as soon as they arise • Regularly polling staff about what is working, what isn’t, and what they need	“We did a QI project last year when we got our metrics and we did not like our number of days from regulatory packet to final contract.” “It’s the denial part….you’ve got this whole list of excuses, but then you realize that other centers face similar challenges but are doing better. It was a great motivator for us to see how underperforming our center was compared to others. So we presented it (our metrics report) to the group and started talking about ideas to help improve recruitment.” “About three times a year, I ask them individually a list of questions: What’s working? What’s not working?” Is there someone I should recognize who has really made your job or life better? Do you have the tools you need to do your job?”
Great Team Dynamics	6	• Shared vision about the value of the work being done • Getting to know each other outside of work • Research teams work together to raise money for CF research	“There is a program-wide sense of commitment and camaraderie. We all not only work together here, but we all turn out for Great Strides [fund-raising event]. There is this whole sense of community that this is something that really matters.”
Shared, Efficient Processes	5	• Longevity of staff resulted in shared processes that were not always written down • Written processes, checklists, white boards • Shared calendars • Mock or practice study visit prior to study initiation	“There is an order in which we do things, these are the things we do simultaneously, this our time frame. There is a lot of meticulous cross checking and people keep things up to date and filed so that you can go back and find things.” “I am just constantly in awe of how well it’s run and how organized everyone is, from all these boards telling me what trials are coming up and when all of the subject visits are.” “We prep well in advance anything that we could possibly need at a subject visit, it’s all right there. “You are never running around saying, ‘oh, I need this or I need that’…It’s already put together and ready.”
Business-like Approach	5	• Develop adequate study budgets that cover all costs, and team understands the risk of financial loss if enroll fewer than planned number of subjects • Institution allows IRB, budget, and contract activities to run simultaneously (not consecutively) to improve speed of start-up	“…sponsors and customers see us as an anomaly in the academic world because we’ve made purposeful decisions to be nimble, to be business-like, to be aware of the world outside of here and to be flexible if needed.” “When we produce value, people will come back to us for value and they will keep coming back to us for value.”
IT Systems	3	• Databases used to identify potential subjects • Electronic tracking systems used to facilitate and monitor processes, financial accountability, and metrics	“We involve our data management group…and I think that this has been instrumental in transforming both clinical care and research. We can send them inclusion/exclusion criteria, and within 24 hours we have the exact number of subjects who potentially meet eligibility”
Balance of CF Programs	2	• Adult and pediatric research teams equally invested in research • Clinical care and research are equally valued • Basic research also valued	“As the clinical director, it is really important for us to empower the research people, to let them know that we want them involved…not that it is just OK if you come by to talk to this patient about a study, but that we WANT you to come and talk to this patient about that study.”
Institutional Support of Clinical Research	2	• Institution supports research activities (budget development, contract negotiation, regulatory document preparation, pool of research coordinators) • Institution provides adequate, well-located space for research visits and research staff office space	“It really helped when we moved. We didn’t use to have office space together, but now we are on the same floor, we see each other every day….we just talk more.”

*Number of visited centers where this characteristic was identified as a key contributor of success.

CF = cystic fibrosis, IT = information technology, PI = principal investigator, QI = quality improvement