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Improve your site's relationship with monitors
Coordinators and monitors can compromise
Clear communication and a good understanding of expectations and goals are necessary elements of the relationship between clinical trial professionals and clinical research monitors.
However, each person may have a different perspective and objective, so finding common ground sometimes can be a challenge.
"One thing people need to recognize is that motivations between monitors and study coordinators are different," says Celine M. Clive, MBA, president of Polaris Clinical Research Consultants Inc. of Cary, NC.
"Although study coordinators and monitors are both interested in research, study coordinators are focused on clinical care of patients — as they should be," Clive says. "But the clinical care is secondary for monitors."
For example, monitors focus on retrieving data and retrieving regulatory documents, Clive says.
These aspects of research often are of secondary concern to study coordinators who make study participants their main focus, she adds.
"The coordinator does make research a priority," Clive explains. "But most of the time, she thinks that being in this research is the best clinical option for that person."
Study coordinators will find that sponsors each have their own ways of doing things, and adapting to many different expectations can be a challenge, notes Jane K. Downs, RN, CCRC, research director of Raleigh Neurology Associates of Raleigh, NC. Downs worked as a monitor for several years in the 1990s, but she missed caring for patients and so switched to the other side of the fence.
"You have dedicated, invested people on both sides, and that can cause conflicts," Downs says.
"The study coordinator will say, 'I've always done it this way,' and the monitor will say, 'I've always done it this way,'" Downs explains. "The key is to compromise and keep your eyes focused on what's really important, which — to me — is the patient."
Most of the time, study coordinators and monitors can find common ground, which is why Clive and Downs offer these tips on how to improve the relationship between study coordinators and clinical research monitors:
• Help monitors understand the study's science. New monitors sometimes understand research regulations, but do not understand the science and medicine, Clive says.
Study coordinators typically specialize in one therapeutic area, and so they know that science in depth. Monitors go from study to study and have to be knowledgeable, at least shallowly, on a variety of clinical areas, Clive notes.
"So study coordinators can really help the monitor by actually instructing the monitor on this science and medicine," she adds.
One obstacle to this is time. "Monitors have such a tight time frame that while they may really appreciate the additional instruction, they often have limited time at the site and can't get their work done if they take time for training," Clive adds. "But I think they'd be more effective in their work if they took time for training."
Study coordinators can help by giving monitors any of the patient information about the study, Clive suggests.
"You can take that a step higher and maybe the investigator has published some papers on the disease state studied, and the monitor should be reading the literature that was published by the investigator," Clive adds.
• Compromise, compromise, compromise. "If a coordinator and monitor are having a tough time at something, just say, 'Let's look at this from both perspectives,'" Downs suggests.
For example, study coordinators often do not like to file memos because they are red flags to the FDA that something is wrong, Downs says.
"If there's a problem with one patient on one issue, then you should write a note in that patient's chart, and you don't need to file a memo, which should be saved for the big things," Downs explains. "But you find monitors who think memos are the best thing since sliced bread."
When this happens, study coordinators should carefully explain to monitors what the site's policy is with regard to memos, Downs suggests.
Together, coordinators and monitors could reach an agreement about how much should be reported in a memo.
Everyone's goal is to conduct safe and scientifically valid research that will help to bring a good drug to market, and no one's goal is to complete irrelevant paperwork, Downs notes.
"To promote the monitor-coordinator relationship, I try to make them understand this, and I say, "I'll help you out if you'll help me out," Downs says. "Sometimes they ask me if I'll do this one thing for them because they know [we don't think it's necessary], but they need it."
When coordinators compromise and give in a little to monitors, they might expect something in return.
"I'll do the favor for them, but I'll want them to pick up the phone for me the next time I have a crisis," Downs says.
• Learn from monitors. Monitors might need to update study coordinators about regulations, and if both professionals look at their relationship from a collaborative perspective, they'll both benefit, Clive says.
However, coordinators should keep in mind that some of the rules that monitors say are regulations are company policies and not actual government requirements, Clive notes.
"Coordinators will get a variety of instruction and sometimes it's contrarian instruction because of various company policies," Clive explains. "So what happens is the poor coordinator is being told, 'Here you need an original, and here you need a copy,' and it's different according to whom is asking for it."
None of these types of details are driven by regulations, she says.
"It helps to understand where there is flexibility in terms of company policies, versus no flexibility because of the regulations," Clive says. "If coordinators and monitors are building a good rapport, they can foster that understanding."
• Build rapport. A lot of information, as well as a better rapport, can be conveyed in the on-site visits, Clive says.
"When the monitor goes to visit the study coordinator, and they're both sitting side by side, it gives them a good opportunity to explain why they're doing it this way and what is needed from both points of view," Clive says. "So I put a lot of stock in the on-site visit."
Also, monitors should be sensitive to the fact that clinical trial coordinators may feel overwhelmed by the documentation and electronic data requirements, Clive notes.
"Electronic case report forms were supposed to make everyone's jobs easier, but it transferred the task of data entry to coordinators, so it resulted in more work for coordinators," Clive explains. "It sped up the data retrieval process, and it may have eliminated things like tracking logs, but it doesn't save coordinators that much time."
Monitors have many pressures that coordinators may not understand, Downs says.
"Monitors might have a standard operating procedure (SOP) at their clinical research organization that says they have to turn in a monitoring report within five days of doing the visit," Downs explains. "If coordinators don't give monitors the information they need for the report then they can't do their job."
Coordinators should keep in mind that monitors have an important job too because the sponsor is paying the site to get the research information, and it's the monitor's job to give the sponsor information for the study, Downs adds.
Finally, coordinators should think of monitors as part of their research team and treat them with patience, even when there's a heated disagreement, Downs suggests.
"You can't just say 'No' for the fun of it," Downs says. "When monitors get really excited about something, say, "I'll think about that and get back to you,' letting the situation cool down."
Often what seems like a crisis today is not really a crisis and once things cool down, coordinators and monitors can come back to that issue, she adds.