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Coordinators train investigators
Research program administrators often find that it’s difficult to convince investigators to attend voluntary education courses, but this doesn’t mean that institutions should give up on educating researchers. At least one institution has found a way to indirectly teach and update investigators about clinical trials rules, regulations, and processes.
The research training and education program at Baylor Research Institute in Dallas focuses on teaching clinical trials coordinators, who are then expected to go back to their studies and use their new knowledge to better inform their principal investigators.
"I think that many sites, including ours, struggled with how to get investigators to these training programs," says Betsy Stein, CCRC, director of clinical research. "I realized this year that the most effective tool we have in educating our investigators and doing quality research here is by investing in our research coordinators."
After coordinators attend the classes, they’ll talk about it with investigators, and because research coordinators and investigators form a close team, this is an efficient and effective way to teach investigators, she adds.
"By investing in coordinators we ultimately are investing in our investigators," Stein explains. "They pass the information on in a way that ultimately teaches our investigators without their having to sit in a class."
The research coordinators are the ones who may have the greatest affect on research quality, she notes.
When the Baylor program began, it offered a two-day good clinical practice (GCP) course twice a year, Stein notes.
"The first time we offered it we taught the fundamentals, and that was meant to be applicable to new coordinators and experienced staff," she explains. "The next year, we offered a GCP course that takes it to the next level, building on the education we’re providing."
Now that the institute is in its third year of the revamped education program, there is a fundamentals course offered in the fall and an advanced GCP course in the spring, Stein reports.
Course topics include guidance on developing study budgets and research billing compliance, and there is a monthly research coordinator meeting, she adds.
A new goal is to offer shorter programs that can be held in the morning or at lunch-time or in the afternoon, so if a clinical coordinator is busy doing rounds in the morning, he or she will have a more convenient time available for attending a class, says Elizabeth Cothran, MS, CIP, director of the office of research subjects protection.
The educational courses also offer continuing education credits so licensed staff may use these to maintain their licenses and certifications, Stein notes. "The offering of educational credits is a big incentive and it’s very appreciated, especially since some programs are fairly long," she says.
In all, coordinators attend three coordinator meetings in one quarter, averaging about eight hours, Stein says.
Staff feedback evaluations confirm that participants feel the GCP training is the most important educational program provided by the institution, she says.
Professional medical trial trainers teach the courses, and this gives the program credibility in the eyes of experienced study coordinators, Stein adds.
"The people we have teach a course like that have been research nurses in the past and have worked as a monitor, and they bring a rounded experience with them that coordinators relate to," she says.
Boning up on AE reporting
"One of the most popular sessions is on adverse event [AE] reporting," Cothran says.
The adverse event reporting session covers reporting requirements, evaluating AEs, timelines for reporting, the role of monitors and sponsors, and how AE reporting impacts drug labels, she explains.
"In the drug approval process, the labeling that shows up as possible side effects in the Physician’s Desk Reference come from adverse event reports made during the clinical trial, including things reported as possibly and probably related to the drug," Cothran says. "It’s important for investigators to really evaluate the event and relationship to the study drug because that will have long-term implications for labeling on a product."
The AE session stresses how principal investigators are chosen by the sponsor for their expertise, including their judgment about whether a particular symptom is related or not to a study drug, Stein says.
"If you write down that everything is possibly related, then that kicks into a Yes,’ and that can result in some bizarre things being attributed to a side effect," she notes. "One example we use in class is how a drug label says a drug causes menstrual cramps when it really doesn’t."
While it’s the PI’s responsibility to make certain AE reporting is fair and accurate, it’s the research nurses’ responsibility to complete the case report forms as clearly and accurately as possible, Stein adds.
Several times a year, the institute offers a budget writing course as either a refresher or training session that is conducted with the manager of the grants and contracts department, she reports.
The two-hour class includes a presentation piece that discusses the kinds of items that need to be taken into account during the creation of a study budget, including hidden costs. The class also offers research coordinators a look at tools that are available for developing a budget and the in-class use of a budget template for practice, Stein says.
"We have an Excel spreadsheet custom-designed for our site, and we have a sample budget with numbers they can put into the budget template," Stein explains. "They learn how to move through the template and enter data."
A separate course on research billing compliance covers best practices to ensure correct and accurate billing so that all items included in the study budget are done only for research purposes and are appropriately billed only to the research study and not to the patient’s insurer, Stein says.
"This is a complicated process that require special training for coordinators with special forms," she says.
The institution’s central billing staff assist in teaching this session, which helps study coordinators learn how the day-to-day handling of billing works and provides them an opportunity to put a face with a name, since they’ll be dealing with the billing staff on a regular basis, Stein adds.
One of the new programs for study coordinators involves how to successfully complete IRB forms, Cothran says.
"This class goes through all of the IRB forms, the purpose for them, what the IRB is looking for, things we’ve seen that are good and bad, and what’s important," she says. "I’ve had a lot of requests for this topic and decided to put it together as a small class, held four times before the end of the year."
So far the class has been booked each time and has received positive feedback, Cothran says.
Besides the class sessions, the institution also provides on-line training that’s available at any time for investigators to receive their credentials and a CD-ROM education on topics such as shipping blood samples, Stein says.
"We try to provide a variety of educational approaches and not just classroom teaching," she says. "This is an important part of the program."