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Spend a dollar on training, save a few more on fines
Train your staff, or risk noncompliance
Do you want a compliant clinical research program? Start with training and education, clinical research administrators advise. Otherwise, you could end up paying millions if your staff make a critical mistake, such as improper billing.
Training isn’t cheap. Some programs spend $20,000 or more on a one-day off-site training event held every few months. Some programs report spending $80,000 and up in a year on direct costs for training, education, and auditing.
"I expect these costs to rise as the requirements for institutional accreditation begin to be implemented," says Lynette M. Schenkel, administrative director of research and academic affairs at Beth Israel Deaconess Medical Center in Boston.
You want to spend your dollars wisely, so consider these suggestions from your peers:
• Assign mentors. The Jacksonville (FL) Center for Clinical Research pairs new coordinators with an experienced mentor during training, says Michael Koren, MD, FACC, chief executive officer.
The mentor determines how the individual obtains training, he says. "It has to do with their previous experience and the type of setting they’re involved with," Koren says.
• Use the web. At the Jacksonville center, a large portion of the training is a web site where staff, including physicians, can access a series of questions to assess their knowledge of various clinical trial issues, including regulatory issues and clinical issues. Different tracks have been created for different staff members. The web site was developed internally, but other programs can access the site for a $2,500 first-year site license fee and $1,000 annual fee in following years, which includes training of flagship staff.
During employees’ orientation, they are introduced to the web site, which can be accessed at computer stations in the facility, Koren says.
The site is self-directed, and the facility’s standard operating procedures have been integrated into it, he explains. "If you don’t know the answer, the program takes you to where you can find the answers."
• Consider off-site in-house training. Koren’s facility offers an intense training seminar twice a year at a restaurant, hotel, or staff person’s house. A comprehensive list of topics is covered, he says. The costs range from $15,000-$20,000, which covers meals and a night at a hotel for 50-60 staff members, plus speakers’ fees.
• Supplement with independent training providers. Three advantages of independent training providers are that they can come to you, tailor their program to suit your needs, and offer a fresh voice, Schenkel says.
"Instead of your research community hearing the same people sometimes drone on about the same things, independent training providers have a different way of presenting the same information and can provide recognizable, yet anonymous, case studies from other institutions," she says.
The disadvantages is that no independent provider is ever going to know the nitty-gritty details of your operations, such as your systems support, Schenkel says. "That is why use of independent providers should be an important supplement, but not your sole training imitative," she says.
• Look at on-line certification programs. Beth Israel Deaconess requires all of its researchers, clinical research staff, investigational review board (IRB) committee members, and IRB staff to go through an internally developed on-line certification program.
The certification asks a series of questions that the users must answer, Schenkel says. If a user answers incorrectly, the correct information is pulled up on-screen in a dialog box that he or she must read through, she says. Subsequently, the user returns to the certification screens and correctly responds to the question before moving on.
"This assures the institution of a basic level of knowledge on the part of all individuals engaged in or supporting the process of clinical research," Schenkel says.
Beth Israel Deaconess requires recertification on an annual basis.
"The only disadvantage I can perceive in this process is that if you have an individual who is very brand new to clinical research, they may not learn enough from the on-line certification process," Schenkel says.
• Use national trade associations. Supplement your training with participation in national trade associations, such as the Public Responsibility in Medicine and Research and the Applied Research Ethics National Association, both based in Boston, Schenkel suggests.
"It provides staff with focused time for education, away from the distractions of their regular day-to-day work," she says. "It allows them to network and understand the importance of good clinical research at a national level, rather than their everyday view of the clinical research world."
In addition, Beth Israel Deaconess regularly sends staff to regional and teleconference meetings, she says. And there is a final step to training and education, Schenkel emphasizes.
Use spot checks to ensure staff are correctly applying institutional and regulatory requirements, she says. You will realize a payoff when your staff keep your program compliant, Schenkel maintains.
"A good training and education program does not come without institutional commitment and investment, but is worth all the accompanying headaches when the results are realized," she says.
[Editor’s note: For information on the license for the web site developed by the Jacksonville Center for Clinical Research, contact Gary Woods at (904) 739-9057.]