As part of the IU School of Medicine’s COVID-19 vaccine trial, Catherine Bauer-Martinez, REDCap Administrator for UITS Research Technologies, designed and built the behind-the-scenes research and operations data capture for the AstraZeneca COVID-19 study. “Initially administrators were not sure which vaccine supplier we would be partnered with,” said Bauer-Martinez, describing the uncertainties of early summer 2020, before AstraZeneca was allocated by the Food and Drug Administration.“From the beginning, I was excited to be part of the team and contribute to this important COVID-19 vaccine clinical trial at IU School of Medicine,” she said.
It was a lot of building and then tearing down and having to reprogram and move in a different direction. Database design and management at this scale of research is really all about tailoring and creating a database that fits the needs of the study and the study team.
Catherine Bauer-Martinez, REDCap Application Administrator, Advanced Biomedical IT Core (ABITC), University Information Technology Services - Research Technologies, Indiana University
Keeping up with needs of both researchers and clinicians proved a challenge that involved reworking the clinical trial’s data flow multiple times. One issue early on was scaling the ability of the database to handle multiple accesses at once. “There may be up to 75 people working with the data at any given time,” said Bauer-Martinez. “There might be someone entering data for recruitment while simultaneously nurses are entering the clinical data, and administrative staff are entering the administrative data. The REDCap clinical database needed to be robust enough to handle the workflows for the initial data entry and also follow participants during the two-year study period.” she said, describing a workaround she developed to streamline the study’s complex operational flow.
The COVID-19 vaccine trial marked a first for IU’s REDCap team, as well as the largest clinical trial implemented by the IU School of Medicine to date. With thousands of data fields following over 500 participants for two years, which were screened from an initial population of over 1400 people. After trial participants had been selected, the system needed to scale a seven-fold increase in data point collection, from an initial sixty-five thousand records, to over four hundred thousand. This pace meant data needed to be easily accessible. “The School of Medicine staff were seeing nine or ten people a day. I interviewed the team to learn their process so I could understand how to build and design the REDCap database to best meet their needs,” said Bauer-Martinez. “It was a lot of building and then tearing down and having to reprogram and move in a different direction. Database design and management at this scale of research is really all about tailoring and creating a database that fits the needs of the study and the study team,” she continued.
Because data capture needed to facilitate people without backgrounds in data science, readability was key. “We worked on ways to gather the data in a way that was easy to use and understand, with a lot of quality checks, branching logic, and calculated fields,” she said. One important feature Bauer-Martinez developed with colleague Andy Arenson was using an SQL field to link two REDCap clinical databases together. “This allowed data to flow seamlessly between the two clinical databases.” Another crucial check involved the inclusion and exclusion criteria to determine trial eligibility - a definition which could change as the study, and participants’ lives, progress. “For example, many of the health professionals left the study because, when it became clear vaccination could be implemented for health care workers, they were unblinded because they needed to know if they had the vaccine,” she said.
Bauer-Martinez says that while the AstraZeneca vaccine was not widely implemented stateside, she was fortunate to present her work on trial implementation at the 2021 international REDCap conference. She co-presented alongside the leader of the Clinical Trials IT and Development from Oxford University who also used REDCap in UK-based trials. Oxford University in the United Kingdom was the developer of the AstraZeneca vaccine.