Training program offers best practices

Initial training lasts all day

Research coordinator training is an area that often is short-changed at institutions.

The traditional way education is done for clinical research staff could be labeled a baptism by fire, says Joan Bardsley, RN, CDE, MBA, an assistant vice president for scientific affairs at MedStar Research Institute (MRI) in Hyattsville, MD.

MedStar Health is the largest provider of health care in the District of Columbia/Baltimore, MD, area. The research institute is a part of MedStar Health and supports research throughout the system, as well as employing researchers to conduct research.

"When we first got into the practice of looking at research coordination training, we found very few published best practice models," Bardsley says.

Research sites either hired staff with experience, and could count on these individuals to get to work immediately, or they had to provide more extensive mentoring to people who did not have much experience, she explains.

When credentialing became available for these disciplines, MedStar Research Institute managers thought it would be very important for research coordinators employed at the institute to meet the high standards set by the Association of Clinical Research Professionals of Alexandria, VA, Bardsley says.

"We felt we needed to do something as an institution to support those credentialing efforts, so we did surveys and came up with a comprehensive program, including a preceptor program and ongoing training," Bardsley says.

Here's how it works:

New coordinator training: "We have new coordinator training where any coordinator new to MedStar, and that includes those who are not just new by experience, is required to take an all-day coordinator education course," Bardsley says.

The course covers the basics of good clinical practice (GCP), as well as these other topics:

- introduction to clinical research and GCPs;
- informed consent;
- practical approaches to IRB submission;
- drug and device accountability;
- ethical considerations in clinical research;
- recruitment and enrollment;
- data collection;
- principal researcher responsibilities and study team responsibilities.

The training also introduces new staff to employees in other departments.

"The program evaluations we've received about the new coordinator training have been positive," Bardsley says."The new employees like getting together, and they've offered suggestions for other topics to include."

CITI program: The Collaborative IRB Training Initiative (CITI) offers basic human subjects protection education and allows institutions to post additional instruction materials specific to their own organization.

"The second piece is the CITI program, which is well known in the research arena for offering training," Bardsley says.

"We wrote modules that are customized to research at MRI. Our employees take basic core CITI modules, plus 12 of our own modules," she says."This ensures they're going beyond the basics."

Each module takes 20 to 30 minutes to complete, and there are 20 to 30 modules in all, she says.

"They do this during their work time, but we recommend completing them over several days to avoid burnout," Bardsley says.

Research coordinators are required to take all of the modules, she says.

Preceptor program: The preceptor program is in the development stage, but several of the MedStar centers are piloting it, Bardsley notes.

The idea is for every research coordinator to have a preceptor when he or she is hired. The preceptor might not be a supervisor but will be someone responsible for ensuring that a set criterion of tasks and expertise is offered to every coordinator, Bardsley says. (See clinical research coordinator/preceptor checklist.)

Preceptors would have an inclusive checklist of tasks, responsibilities, and competencies for the new hire, and the preceptor would be responsible for ensuring the new employee performs as appropriate for the position, she says.

The next step will be to formalize the preceptor program and train employees in how to be a preceptor, she adds.

Ongoing training: MedStar has monthly training sessions, except during the months of the all-day coordinator training.

The ongoing training sessions include a lecture on a topic that is new, pertinent, or requested by the coordinators. The hour-long lecture is given in a group setting, or it can be Web-based, Bardsley says. It's held about eight times a year, she says.

The institute tried video conferences, but these didn't work well, so they have switched to a Web-based program . All of the slides are archived, so participants can review them at a later date for reference, Bardsley notes.

Some recent sessions included these topics:

- changes in IRB regulations and IRB processes;
- how to prepare for an audit by the FDA;
- feasibility and cost analysis of clinical trials;
- ethics and human subject protection in research.

Evaluate training programs: "We're very interested in job satisfaction and quality of research," Bardsley says."We're trying to see if the outcomes of these interventions and programs make a difference, and we're looking at the concept of studying it, although we don't have a formal outcome measurement program in place."

There are evaluations and questionnaires given to coordinators, and from these administrators learn what coordinators need in their training, she notes.

"We try to learn from experience, as well as outside resources," she says.

"When we first began training, we often found that the programs weren't strong or structured enough," Bardsley says."So we've tried to put in place a strong, systematic, programmatic education program for coordinators that is for both initial and ongoing training."

The goal is for the training program to help the institute with professional growth and to help staff with job satisfaction and best practices, she adds.