Best Practices

Timely tips on improving Good Clinical Practice

Staff training is crucial

From communication to documentation to staff training, clinical trial sites need to adhere to Good Clinical Practice (GCP) guidelines.

One key is to focus on federal regulations in obtaining informed consent, completing clinical research forms, and submitting protocols to the IRB, says Gina Nesbit, RN, CCRC, research manager at Northeast Georgia Heart Center in Gainesville, GA.

While principal investigators (PIs) are responsible for all practices at their clinical trial sites, there are multiple other research individuals involved, including sub-investigators, pharmacists, laboratory staff, and research coordinators, she notes.

So staff training is paramount.

"When we hire staff they get their training program here," Nesbit says. "We focus on FDA regulations, the informed consent process, IRBs, CRF completion, and all of the things required with the conduction of clinical research and protocol deviations."

Principal investigators should emphasize communication between research staff and have regular meetings with coordinators to discuss enrollment, adverse events, MedWatch reports, safety reports, and participants' lab values, she adds.

"The PI should always be aware of what's going on," Nesbit says. "So we meet regularly with PIs and have a research committee that discusses what is going on with the trial."

Monitoring MedWatch reports, adverse events, and the trial's execution are all part of GCP. Nesbit offers these tips on improving GCP:

• Keep patients informed: "At our site we spend a great deal of time with patient education," Nesbit says.

As a cardiology practice, many of the site's trials deal with people who have had a heart attack.

"When someone has a heart attack, that's new to them, and they're overwhelmed with the process," Nesbit says. "So when we come in to discuss a clinical trial it's really overwhelming to them."

This means that the informed consent process must focus on what is going on with the patient's disease and treatment and helping them understand that process, she says.

"Once they understand the medical process, we say, 'Now let's talk about the study so you can compare what we do every day to what we propose in the study,'" Nesbit says.

"Informed consent is not something that occurs one time at the beginning of the trial, it's something that is ongoing throughout their participation," she adds. "So with follow-up visits, talking to patients, and throughout the patient's time, you're constantly reiterating study procedures, what the study is about."

• Communicate continually with IRB: "We constantly communicate with the IRB with regard to adverse events, protocol deviations, MedWatch reports, and the continuing review process for the trial," Nesbit says.

When the trial has an adverse event, this is reported on a specific form and sent to the IRB. The MedWatch reports are compiled and sent to the IRB at the continuing review.

The site reports all AEs, even if they are unrelated to the product being studied, Nesbit says.

"We have a lot of cardiac trials, and if a patient is admitted to the hospital with a cold, then it's an adverse event because it's a hospitalization," she explains. "But it's not product-related."

Or if a patient is seen in the emergency room because he broke a toe, then that's reported, depending on how the protocol is designed, she adds.

• Document everything: "If it's not documented, it didn't happen," Nesbit says. "Documentation is extremely important with this patient population."

If a patient has an adverse event that requires sponsor action, then it's very important all documentation related to that AE is complete and accurate.

"If it's not complete then that makes the adjudication much more difficult for the sponsor, so every effort is made to make sure the documentation is complete," Nesbit says.

Look at the documentation as telling a story, she suggests.

"I once had a monitor tell me that when you are putting together your regulatory books and case report form binders about the patient you want to `tell a story,'" she says. "It has to have a flow to it, and so the way we've organized our regulatory binders, patient binders, and flow of communication is to make sure it's always telling a story."

• Train staff and create checks and balances: Everyone who works with the institution's IRB has to go through GCP training online, Nesbit says.

"Every year we review GCP within our own practice so everyone remains up-to-date, and it's always on the forefront of everyone's mind," she adds. "Also, at investigators' meetings, they reinforce GCP and remind them of those principles."

For clinical trials that have outside sponsors, the checks and balances primarily come from site monitors who regularly review data, comparing what's in the case report form to the patient's chart, Nesbit notes.