Cumbersome paper logs
Oncology Consultants used the industry’s standard paper logs to collect patient study data. As the established research program continued to grow, paper logs no longer fit the team’s needs, because it required the team to be in the same location to ensure timely investigator sign-off. At Oncology Consultants, Dr. Julio Peguero, Research Director, and the investigators often rotate between locations, meaning sign-off could be delayed if the investigator left the location. “This resulted in delays that were not keeping with study sponsor expectations,” explained Research Department Administrator Laura Guerra, RN, CCRC. The paper log also allowed variation in data entry, such as different date notations, that could lead to monitor queries. Updates and corrections to the log could make it difficult to read.
As a temporary solution, the team created a template in their EHR to replace the paper log. This allowed all members to work on the log regardless of location. However, it was still difficult to track the time to log review and sign-off, a key quality metric.
The Oncology Consultants team now utilizes a set of electronic research documentation logs in OncoEMR®. They are actively using the adverse event log and are a beta testing site for the past medical and surgical history log. Oncology Consultants highlighted the unsigned events report as a key benefit to their practice’s sign-off workflow. “I use the report to follow up with investigators who haven’t signed off on their adverse events,” says Research Quality Assurance Manager Camelia Lazalde. “I can also see where documentation is lagging. I then follow up specifically with those individuals.”
Oncology Consultants also emphasized how guided data entry in the electronic logs has been key to standardizing the entries. For example, all date notations are in a day/month/year format. A built-in CTCAE search functionality helps research coordinators easily enter proper terminology. A collapsible comprehensive change history also keeps the log free of ambiguity.
Timely documentation and sign-off
Just a few months into using the electronic adverse events log, Oncology Consultants has already seen both improvements in time to sign off and fewer monitor queries. The median time to investigator review and sign-off is only five hours, versus the 24–48 hours it may have taken on a paper log. “With paper, it was a manual process to determine whether adverse events were being signed in a timely manner,” Camelia said. “Currently, I can easily track which adverse events are unsigned, which improves our data quality.” Laura also shared that OncoEMR® has reduced monitor queries around data entry, especially queries due to variation in logging dates.
Oncology Consultants is using the electronic research logs in OncoEMR® for studies that support CTCAE versions 4.03 and 5.0. They are also continuing to partner with Flatiron to develop additional electronic research documentation logs in OncoEMR®.
This allows me to easily track adverse events that are unsigned by investigators, improving data quality.
About Oncology Consultants
Oncology Consultants is located in Houston, Texas and is staffed by 15 medical oncologists, two radiation oncologists and four advanced practice providers, with a 14-person research team. OC Houston has a robust clinical research department and participates in the Oncology Care Model. They use Flatiron’s integrated OncoCloud™ technology suite, including OncoEMR® and OncoTrials®.
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