Erin Vidra, Director of Clinical Research Compliance, gives researchers an outside POV
For a research project, getting funded is just the beginning. Successfully executing the proposed work and staying within the approved protocols requires a research team to practice cooperation, communication and diligence.
Erin Vidra, director of clinical & human subject research compliance in the Office of the Vice Chancellor for Research, has seen that process from within as a program manager and regulatory coordinator for several institutions. In her current role at UIC, she uses that experience to help researchers meet the requirements of their grant and keep their research running smoothly.
Since the program started last year, Vidra has completed more than 50 monitoring visits where she has advised and educated project teams on the steps needed to achieve compliance with sponsor and regulatory policies. But her assistance goes beyond this formal process.
What is the Clinical and Human Subject Research Compliance Program?
Once a study is IRB approved, we come in and review or monitor the study to make sure they are meeting the required regulations from agencies such as the FDA or NIH. We make sure the researchers are compliant when conducting their study.
This process involves “monitoring visits” with projects and their investigators. How are studies selected, and what is their purpose?
For the most part, they're chosen at random. The study can be selected after IRB approval. We review the participants’ research charts, which includes documentation of the consent process, data collection and essential regulatory documents.
It's really two components. It's the regulatory side, which is making sure you're following FDA/NIH requirements, and in following those regulations we confirm there is no risk to participants.
What are the steps of a monitoring visit?
We set up a time to meet with the investigators, and we start the process of monitoring the study even before we meet. We review all IRB submissions, confirm staff training, make sure any agreements made with outside institutions are in place, and if we have a question we reach out to the appropriate departments. The participant charts selected are based on the number of participants enrolled, and we randomly select those that we will review. We confirm the documentation collected mirrors what is written in the protocol. If you're doing everything your protocol states and following the regulations, then you really have nothing to worry about.
When you are finished, what are the potential outcomes?
When the monitoring visit is complete a final report is sent out which includes all our findings as well as education and guidance for the staff to become compliant in any areas that were lacking.
We want to provide education. If we find something that is incorrect or if there's an error, it is about correcting and clarifying, then documenting why the error occurred, establishing a process for moving forward and ensuring the compliance portion is correct. We want to focus on education from the investigators down to coordinators.
Outside of monitoring visits, how else does your office help educate researchers about compliance?
Any time a new study is IRB-approved, I send out a welcome email that introduces our program as well as provides information to researchers; this includes links to our landing page. We’ve broken it down based on the type of study sponsor: if it’s FDA you should have this; NIH, you should have that. Providing this can help researchers and staff when they have questions or prepare to begin a new study, there is a place to go for help.
We’ve also linked up with the Center for Clinical and Translational Science and we’re now part of their masterclass program. We're working on rolling out information for other departments throughout UIC.
What do you hear from researchers when you reach out to them?
People sometimes get panicky when they first hear from us, but we’re not the police. It's human error, people make mistakes. It's recognizing that, correcting your error, moving forward and learning from it. Many researchers are appreciative of the visit, and that's what we want.
Investigators who I've previously monitored will ask us to monitor other studies or say that their sponsor is performing an audit and they’d like us to review their study documents. It's like a dry run and they’re all set for the visit from the sponsor. I think it’s a relief knowing that we have done an audit first and everything was okay.
What do you enjoy about working at UIC?
Previously, I was at private institutions. UIC has so much more variety. There’s more going on and happening even in the world of research compliance, the investigators and the type of research that they do. I find it quite fascinating.