The Rockefeller University Hospital Expedites Protocols with IRB

Challenge

The Rockefeller University is the oldest biomedical research institute in the United States, with a 125+ year history of promoting the scientific study of medicine. The storied — but relatively small — Rockefeller University Hospital exists solely to conduct clinical research. Rather than a general-care hospital, it is designed to facilitate clinical research for both the investigator and the research participant. The Hospital has recently started undergoing a transition to become an Outpatient Diagnostic and Treatment Center.

Although Rockefeller University has a large IT department responsible for maintaining infrastructure and servers, the Hospital itself has its own informatics department responsible for overseeing its clinical and research applications and databases.

The hospital’s research management software was originally developed in-house, and by 2005 its digital infrastructure included separate homegrown systems for managing schedules, patient registration and visit tracking, IRB protocol submissions, protocol hosting, adverse events and deviation violation reporting.

While an improvement over paper records and processes, these systems were largely siloed with minimal integration, most requiring time-consuming manual data entry that introduced human error risks. Without easy integrations or accessible data, providing status updates building reports required a significant time and effort commitment from administrators. Study progress reports could take up to a year to complete, and required collaboration from outside vendors who didn’t always understand the hospital’s processes, requirements, or nomenclature.

“We had several different siloed systems that required manual data entry, and when you’re inputting data manually, you can make mistakes.”
Technical Project Lead

Solution

With research activity continuing to increase and siloed, homegrown systems slowing IRB protocol submissions and approvals, the hospital’s leadership looked for a way to consolidate their workflows on one platform and began transitioning to vendor software in 2006.

The stakeholders of the Institutional Review Boards were all well-versed in human subject protocols and familiar with good clinical practices. For new hires, however, the application process could be lengthy and confusing, requiring back-and-forth clarification emails and follow-up questions. With this in mind, leadership looked for a vendor solution that could incorporate best-practices into the submission workflow itself to facilitate faster handoffs and teach investigators how to write a proposal in the process.

When weighing vendor options, they were impressed with Cayuse IRB’s flexibility for creating customized study applications for human subject protocols and other submissions. The ability to write questions an investigator may have into the application would help investigators better understand submission requirements without reaching out to veteran investigators.

“Leadership saw that with IRB, you can actually write the protocol the way you want, especially initially with the submission form.”
Technical Project Lead

Ultimately, the hospital implemented IRB, and has continued using the solution for protocol management over the past 18 years.

Results

IRB has proven to be a large improvement over Rockefeller University Hospital’s former homegrown protocol submission system, and is now a reliable fixture in the hospital’s electronic research administration infrastructure.

Where leadership sought a more centralized solution for protocol management, IRB provides full transparency into statuses and updates through a single, secure sign-on. Integrations with other digital infrastructure — including electronic health records, CITI data, COI disclosures, and grants management software — reduce the time needed to complete forms, ensure more accurate data, and help provide a full, up-to-date view of study details without searching through separate repositories.

Additionally, the team now has more robust reporting capabilities thanks to the software’s centralized database access. Rather than relying on a vendor to pull data and write reports, individuals can directly access study data, build reports, and upload completed reports to IRB’s reporting dashboard for end users. And with forms designed with the hospital’s specific requirements in mind, stakeholders can feel confident that the data used for their reporting is accurate. Different departments across the university have also found the reports generated with IRB data to be helpful for informing decisions and staying up-to-date with study progress.

Perhaps most importantly, IRB has helped to dramatically simplify workflows for human subject protocol submissions, reviews, and outcomes. Where submissions previously could take months to receive final approval due to several factors, like confusing or ambiguous requirements and manual entry errors, brand new protocol submissions take no more than 30 days with IRB.

“With IRB, a study will take a maximum of 30 days to approve when a brand new protocol comes in.”
Technical Project Lead

Application forms are now designed with new investigators in mind, not just those who know exactly what is required from them, and why. Built-in prompts will ask for any missing details so no information is overlooked before completing a submission, and if a member of the study team is unclear about an answer, they can contact the facilitation department for a quick response and explanation. When an application is complete, applicants receive a report stipulation for confirmation of accuracy and an easily-traceable record.

Overall, the team is happy to report that IRB has helped save investigators, administrators, and review board members save significant time and effort, seamlessly reinforced training for new team members to ensure future submissions move even faster.