Organization achieves success with EDC system

It eliminates paper, automates corrections

A major research organization in the Northeast successfully uses an electronic data capture (EDC) system with hundreds of clinical trials each year.

Dana-Farber/Harvard Cancer Center in Boston, MA, has used an EDC system for research since 2005, achieving better quality and improved turnaround time and increased efficiency, says Marina Nillni, PMP, EDC program manager for the DFHCC.

"We conduct a lot of our own research," Nillni says. "Investigators do their own trials with sponsorship from the government, and these EDC tools are used to manage data and conduct principal investigator-initiated studies."

The sponsored trials are conducted with whatever electronic tools the sponsors use, she adds.

Nillni outlines these benefits from using an EDC system for clinical trials:

• No more paper case report forms: Using electronic case report forms can save time over the long haul when compared with using paper, printing, mailing, and faxing, Nillni says.

"You also do all of the work upfront," she says. "In EDC you spend a lot of time building those case report forms and analyzing the needs of investigators."

The payoff is when the trial is up and running, the workflow runs smoother, saving time, she adds.

There also are some cost savings, although the electronic solutions have an expensive upfront cost, Nillni notes.

• There can be a reduction in queries to the study teams: "We’ve definitely seen a reduction," Nillni says.

One reason for the reduction is that the EDC has built-in parameters that prevent some common errors involving putting in the wrong decimal point, she says.

"The EDC can fix data with the wrong decimal point rather than having someone send out a query," she says. "A lot of data is immediately corrected by the data entry person."

The EDC system also can correct immediate errors related to data that indicates treatment for the wrong diagnosis. When the wrong diagnosis is plugged into the EDC, it will be identified as an inconsistency and can be fimmediately corrected, Nillni says.

"Quality assurance happens simultaneously," she explains. "As soon as a person has data there is a query and the person has a chance to respond right away."

EDC users can program automatic and complex checks in the system, according to the common mistakes they’ve identified.

• The EDC has system integration within the research organization: "The protocol registration is integrated with the EDC," Nillni says.

"Because we are both site and sponsor, we have a centralized registration system for all our patients participating in clinical trials," She explains. "So any patient who comes through for participating on a clinical trial or even patients who maybe be on a different site all get registered through a centralized registry, and that piece is integrated."

For example, if a subject is enrolled today on a new study, that enrollment is put in the EDC tool that night.

"Every night we populate demographic data, date of birth, case number, gender, all into our EDC tool," Nillni says.

Also, the EDC can send some reporting information to external regulatory agencies and insurance companies, she adds.

The system’s integration capability is limited to demographic information, and it doesn’t extend to the hospitals’ electronic medical systems because these do not capture data in a systematic way that would work for use in clinical trials, Nillni points out.

"In an EDC tool, every data point is coded; we don’t take free text because you can’t do an analysis at a statistical level on free text," she says. "Medical records are not structured in that way."