Creating role of data manager makes it easier for site to handle all EDC
What's good for sponsors is a headache for sites
One of the ironies of the electronic age is that while electronic data capture (EDC) makes collecting and analyzing research data a more efficient process for sponsors, it often is costly and challenging for clinical trial sites.
There probably are more than 20 different EDC systems that any single CT site might see, and CT staff have to learn each of these EDC programs, says Debra Gabrielson, BSN, RN, research administrator of Regional Clinical Research Inc. of Endwell, NY.
"We have to learn the program the sponsor is using to collect the information," Gabrielson says. "So research coordinators who are working on five or six studies might have five or six software programs to use."
This adds considerably to the front-end costs of conducting a clinical trial.
"The hardest part for us was how much time it took a coordinator, who might be a nurse, to be trained on a software program," Gabrielson says. "The coordinator might spend hours training, receive a certificate, and wait months to start putting in data."
Then there will be the headaches of passwords that don't work and other EDC glitches.
"It took us way too much time doing data entry," Gabrielson says. "It was taking us hours more per visit to do this."
So Gabrielson came up with a solution: She designated a coordinator to the role of data entry.
"We had a coordinator who was very good at computers, and she puts in all data for all of our studies," she says. "She makes herself available when we have monitoring visits, and she has a certificate showing that she's trained."
Researchers and research staff give her their source documents and notes, which she reads and then types into the EDC program.
"Since she's a coordinator she knows the kind of information that's needed and the correlation needed with adverse events, concomitant medication, and medical history," Gabrielson notes. "So it's a nice double-check, and if something's not complete, she can go back to the coordinator and have it clarified."
This provides the added benefit of another quality assurance check.
While this change has solved some problems, there remain other issues.
For instance, investigators have to review the electronic data pages to make sure everything is accurate before signing off on them with cumbersome electronic signatures that are more time-consuming than a handwritten name, Gabrielson says.
And for investigators, the EDC training is yet another time commitment and training program they have to add to their protocol training, good clinical practice (GCP) training, and, sometimes, special questionnaire training, she adds.
Also, the site needed more computer stations, which is expensive both in the initial purchase and also in the maintenance of the computers.
"We have to have virus protection and Internet access and pay for that," Gabrielson says. "That's something that shouldn't be minimized — every little bit adds up for a site."
The site designated a separate room for monitors to use when they're accessing the computer files, and the room needed to have Internet access.
All of these expenses can result in thousands of dollars per year.
"EDC takes us longer, and it's not that we don't agree that it's an efficient method," Gabrielson says. "But some sponsors are recognizing how much it costs sites and are increasing what they pay." So Gabrielson tries to get sponsors to cover a one-time fee for EDC training.
The data coordinator has to be trained to use the specific software, and at least one additional person has to be trained as a back-up.
"The problem is that you have a password, so we have to have a few people trained with the password so that we can have access to the information when needed," Gabrielson says.
"What do you do when if the only person who knows the password isn't in the office and the monitor needs some information?" she asks.
Still, it's asking a lot of sites to have them absorb the costs of EDC training, which typically can last four hours.
"Sometimes we have sponsors who pay the training fees," Gabrielson says. The site also tries to have sponsors pay an increased coordinator fee for each visit to cover the time spent on data input.
"Some sponsors do have data capture fees, which I appreciate because they recognize the time it takes to put it in," Gabrielson says. "There is a learning curve — once you learn it you can get better at it."
This is why it saves the site some time to have one person take the lead on data capture.
"I recommend using a medical person," Gabrielson says. "Our data coordinator has worked as a study coordinator before, and she's an LPN."
In this particular case, the role worked out well for both the CT site and the coordinator, who wanted a part-time and more flexible schedule after having a child, she explains.
"She can do work at home at night if needed," Gabrielson says.
Typically, the data coordinator will come into the office, boot up the computer, start taking charts and putting in data from all of the visits, she adds.
"She works in the same office as the coordinator and can get answers from coordinators," she says. "You have to find the right person, just like finding the right coordinator."
A good match for a data coordinator role might be someone with a medical background who is detail-oriented, Gabrielson suggests.
"It worked out for us that we had someone who liked EDC and understood what it meant and who liked working on her own time," she adds.
Study coordinators initially were resistant to the change because they feared that it meant giving up some of their control over the data they collect, Gabrielson notes.
"But after they did it this way for a while, they loved it," she adds. "It gives the coordinator more time to see another patient rather than to have to sit down and put in data after each visit."
One of the ironies of the electronic age is that while electronic data capture (EDC) makes collecting and analyzing research data a more efficient process for sponsors, it often is costly and challenging for clinical trial sites.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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