Research training trends and methodologies

Research training trends and methodologies

Expert offers look at best practices

Requirements for research staff education may not include hard and fast regulations, but they might be part of the expectations held by regulators, sponsors, and others in the research industry. So it’s important to design staff training and education programs in a way that will meet all of these expectations and provide information that staff will retain, says Carol A. Connell, RN, DrBA, director of development operations team lead at Pfizer Inc. in Groton, CT.

For instance, training that relies solely on lectures is less effective than hands-on training, Connell says. "Only 10% of what we hear we retain after two weeks," Connell says. "But we retain 90% of what we say and do." It’s important to realize that parts of the education won't be retained, so the most important information will need to be emphasized in repeated training sessions, she says.

When a study involves international sites, there are additional considerations that must be kept in mind. "There are different religious and national holidays, like the Festival of Lights in India, which lasts a whole week," she says.

Also, each country will have its own local requirements and regulatory agencies, and since health care and communication infrastructures vary from site to site, these differences also have to be considered, she says.

"A lot has to do with understanding what the requirements are and finding someone locally who knows this and has contacts within the community," Connell says. "I have worked in a number of countries and areas where you need to get tribal approval for a protocol." In some countries if the trial involves women, the investigators must speak with the men in the community to make certain they’re comfortable with the trial, as well.

When an institution collaborates with international research sites, it’s important to determine the direct and indirect costs of setting up training, including labor and facility costs, Connell notes.

Some of the goals that might be set for research training include:

• Establish expectations: "Prior to starting any trial, the staff conducting procedures in the trial need to be aware of what needs to be done in the protocol and in imparting informed consent," Connell says. Then during the course of the trial, as new staff join the study, there should be refresher training and education, she says. It’s the monitor’s job to make sure the investigator and coordinator understand procedures and are running the trial with integrity and best practices, Connell notes.

"I would expect the monitor would talk with sites to make sure they’re aware of the different requirements and to see if they see something that’s not done quite the way it should be," she adds.

• Focus on the protocol: "The protocol is a huge document today, and many people do not read it in its entirety from cover to cover," Connell says. "At the initiation visit, we go through the protocol page by page with the relevant staff," she explains. Pfizer usually asks that study coordinators be included in protocol meetings, Connell notes.

People often miss procedures on the flow chart if they’re not highlighted adequately, so a good strategy for preventing this problem is to add laminated cards to the packet clinical trial staff use. Research staff could use the cards during study visit procedures as a quick guide to making sure all procedures are done correctly, Connell suggests.

It’s also helpful to provide study coordinators with research training along with their protocol education because this helps them understand why they’re being asked to do various protocol requirements, Connell says.

• Use initiation visits for training purposes: At initiation visits, education might include standard operating procedures, case report forms, information on the protocol, documentation, regulatory requirements, drug/device accountability, among other items, Connell says.

"We bring to the site samples of packaging so we can show people what to do with it," Connell says.

"And we have special procedures done that are part of the protocol, and we show staff exactly what we want done." For example, if the protocol calls for reading a chest X-ray, the instructor will show the clinical trial staff precisely how to measure heart size, Connell says.

Other strategies for making certain staff have learned to standardize the procedures include using laminated cards and using electronic data capture with links to information that can bring the standards to the people who are entering data, Connell says.