Electronic system improves IRB record management

System reduces human error

A well-organized record keeping system is essential to IRB functions. IRB and research offices might improve their office documentation and efficiency by following a best practice model established by a large research institution.

The Pennsylvania State University, located at University Park, has a research program that handles about 2,500 active study protocols per year, involving human participants research, and there are nearly 1,500 new protocols submitted each year, says Mary Becker, RN, CIP, associate director of the Office for Research Protections at The Pennsylvania State University. The research program's records include research protocols, committee functions, noncompliance reports, adverse events, training, conflicts of interest documents, and research misconduct reports, Becker notes.

"What we have is a wonderful system called the PRAMS system, for protocol review and management system, that is actually an electronic database," Becker says. "It allows us a checks-and-balance system because it shows us the associations between different protocols."

PRAMS, which stands for Protocol Review and Approval Management system, was created with an NIH enhancement grant, Becker says. Having the database reduces human errors and makes it easy for research staff and others to keep up with what's happening in various committees, she says. Also, PRAMS automatically generates a one-year expiration date based on the date of the protocol's last review, Becker adds.

"Reminders are sent out automatically to investigators 75 days prior to expiration and again 45 days prior to expiration, so our staff does not have to generate reminders," she adds. "And if no continuing review application has been received, then it sends out an expiration notice the day it's due to expire."

The system also assists with training records. "We have an on-line IRB training course, and when people come in and take the training and complete a quiz, a record of it comes up on our system and it's entered into the automated PRAM system," Becker says.

When protocols are submitted, if the personnel involved have not completed training, then the system will notify the IRB office, she says.

"The system will not allow us to give a final approval in the electronic system if there's a missing training record for someone involved in the study," Becker explains.

There also is an automated flag for Health Insurance Portability and Accountability Act (HIPAA) training, she adds.

Likewise, if there's biosafety training or some other training that's required for a particular study, then the system notifies the research office about who has completed the required training and who has not, Becker says.

The system will not permit a user to skip through processes, and so it eliminates human error, she notes.

"It also gives us a profile of the reviewers, so the IRB office can go in and look at the IRB [workload] and office members and see how many protocols each person currently is reviewing, and it notes the training and expertise of each reviewer," Becker says.

The next step for PRAM will be online submission of protocols, Becker says. "We're half-way between electronic and paper submissions at this point," she says. "Once we have an online submission for applications, our reviewers will be able to access protocols online and review them through their own system, and the principal investigator could check the status of the review and application online."

The biggest challenge in switching from a paper to electronic system has been trying to customize the application, Becker says. "We call it our wizard because as you are coming to a question, if you answer it one way it will trigger another set of questions, and if you answer another way it will skip those questions and trigger a different set," she explains. "It has been challenging to try to capture everything in this on-line application and make it work so that investigators don't take hours completing it."

The goal is for investigators to spend 30 to 40 minutes on the electronic application, Becker says.

"The best part of the electronic management system is its accuracy," Becker says. "It puts a check and balance system in place, and I think that's a really positive thing."