CR changes result in more trial site work and challenges

Electronic data entry is time-consuming

Clinical trial sites and CT coordinators increasingly feel pressure to fit more work into an already long day.

"I feel sorry for monitors because they've gotten so pressed for time," says Jane K. Downs, RN, CCRC, research director of Raleigh Neurology Associates of Raleigh, NC.

"The CRO wants them to come out and see as many sites as they can," Downs says. "Monitors are crunched for time because everyone wants them to go faster."

This means the monitor typically has very little time to answer questions or return phone calls, and this leaves coordinators with some confusion.

Delegating or gatekeeping?

While the monitor used to be the site's point person for everything, now the CROs are using other staff for handling investigator and coordinator questions and reviewing the site's regulatory documents, Downs notes.

"You now have your site's regulatory document person deal with their regulatory document person," she adds. "And for some companies, there's an in-house monitor who deals with different issues."

So CT coordinators might have to report a problem to several people, or they might have difficulty finding the one person who is supposed to handle a particular issue, Downs says.

"For small sites that have just one coordinator, there might be three or four people you deal with," Downs says.

"Every company has a different way of doing it," she says. "One pharmaceutical company just instituted a policy where you don't call the monitor him or herself."

Instead, CT coordinators are expected to call a different, in-house person who takes care of all the issues that arise and then gives the information to the monitor only when the in-house person believes it's absolutely necessary, Downs adds.

Raleigh Neurology Associates has eight full-time coordinators, including Downs, plus a full-time regulatory/documentation employee and a full-time data entry person. The latter two jobs have become essential because of the workload that CROs have shifted to CT sites when they use an electronic data capturing (EDC) system, Downs says.

"So many studies are going to EDC, and pharmaceutical companies are hesitant to pay for that data entry person," Downs says. "They used to have data entry at their office, but they say it's faster and more economical for them to put it in our house."

But the workload can be crushing for a CT site.

For example, one CRO that uses a special Internet site requires all regulatory documents to be faxed with an individual fax sheet to the web site's main hub, Downs explains.

"So if you have 15 doctors, and they each have a 20-page curriculum vitae, then your regulatory documentation person is faxing information for eight hours straight because each fax has to have its own barcode," Downs says.

While this system is faster for the CRO, it means more paperwork for the CT site.

One solution might be to have coordinators tote around laptop computers, but this is impractical from a patient care standpoint, Downs says.

"And we have to have source documents," she adds.

No two systems are alike

Another challenge is dealing with many different computer software systems.

Each CRO and/or sponsor has its own software system, and CT sites need to learn how to navigate each one as they input data.

Some of these systems are inflexible and force answers from questions that have no known answer.

For example, one software system requires CT coordinators or data entry workers to answer every question precisely.

If the acceptable response isn't recorded, the software system won't let the CT coordinator continue through the document, Downs says.

"So if we have an 85-year-old patient with Parkinson's disease, the computer wants to know the day the woman first was diagnosed with PD, and it won't take the answer 'unknown,'" Downs says. "You have to come up with some date, but how can you come up with a date?"

This type of software glitch is particularly frustrating when CT professionals need to take care of an emergency, such as a patient hospitalized because of a serious adverse event (SAE) that is associated with the study product, Downs adds.

"So we have to hospitalize a patient, but the computer won't move because I can't give it the exact date her Parkinson's disease started 20 years ago," she says.

And the solution varies widely according to which software is used. One type might permit dashes in place of months and days; another will put a default date, and the data entry worker will have to put a note in the program that says the date is a default date that is not accurate and does not match the source documents, Downs says.

The risk is that an inexperienced coordinator might put in any date to satisfy the computer's technical requirements, but risk posing problems if the site is audited by a regulatory agency, since the electronic data won't match the source document data.

This is the type of situation that must be avoided, and it means the CT site will have to expend more staff time and energy on coming up with a solution that will not result in audit findings, Downs says.

And these types of issues are why it helps if a site can have a dedicated data entry worker.

The data entry worker will need some training, but otherwise should learn the job through experience, Downs says.

"Until they get in there and learn to work with the [various electronic systems], they won't know the ins and outs," she says.

At times the CT site and data entry person will find themselves dealing with an untested computer software system, and their time and energy spent on helping to get out the glitches are not financially compensated.

"We've worked with one electronic system where it would take 30 minutes to finish a page of data," Downs recalls.

The coordinator or data entry worker would click on the save link, but the system wouldn't complete the task for 20 minutes or so, she said.

Yet the site had no option but to transfer the information in this format.