Little things in CT process cause major headaches

Create study regulatory binders

Sometimes it's the little things in the clinical trial (CT) process that can cause the biggest problems down the road.

CT protocol reviews conducted at the Children's Hospital Boston in Boston, MA, offer some insight into the small mistakes that can cause real headaches for CT sites.

For instance, CT sites sometimes use recruitment methods that were not reported to the IRB, but should have been, says Eunice Yim Newbert, MPH, manager of education and quality improvement program at Children's Hospital Boston.

"They sometimes expand the recruitment process to a scope that you think should be reported," Newbert says. "In general, I tend to catch things that should have been reported to the IRB for a review."

For example, if a CT professional visits a potential participant's home to discuss the trial when most of the recruiting has been done at the site, this home visit should be reported to the IRB.

"When CT sites wants to add a new blood draw to a protocol, they'll submit the proposal and wait until it's approved," Newbert says. "But they don't always do this when it involves recruitment practices and how to approach subjects and when and where to obtain informed consent."

Some of these things require a common sense approach, Newbert notes.

If a CT site is sending out more recruitment letters to its patient population, then this might be okay to do without receiving additional IRB approval, she explains.

"But if you send these out to a different subject population, it might feel intrusive to the people receiving them," she adds. "These are the things the IRB members will want to know about, so we encourage principal investigators (PIs) to submit these requests to the IRB."

Study documentation is another area CT sites should focus on, Newbert says.

"Every person has study documentation that could stand improvement," she says.

"Most people at academic settings don't do big studies or research for a living, so it's a lot of knowing what they're supposed to have," Newbert says.

For instance, CT sites should develop a study regulatory binder for each study, she suggests.

"People can look at this binder to see what they need, and it makes it easy for them to keep compliant," Newbert says. "We gave out 100 binders and had great feedback about these."

The three-inch thick binders should be different for Food and Drug Administration (FDA) studies, versus non-FDA studies. At Children's Hospital Boston, the FDA binder has 18 sections and the non-FDA binder has 13 sections, she adds.

"We buy those big white binders and use professionally-printed tabs," Newbert says. "We put in a contact sheet if someone has any questions, and we provide suggestions on how to organize the binder."