November 8, 2013
Support Center Helps CU Spine Surgeon Survive FDA Audit
When you’re facing an audit, it’s nice to have professional resources to support you. Dr. Vikas Patel, chief of orthopaedicspine surgery at the University of Colorado, got a chance to discover just how helpful the new Clinical Research Support Center can be when the FDA comes knocking.
“We had plenty of clinical expertise, but we were just learning how to run clinical trials when this project started 7 years ago,” Dr. Patel explained. “When the FDA came to audit our study they reviewed all of our data from the very beginning of the study. It was scary because they have the power to shut down your research. It was great to have the Support Center help us with that process.”
Responding to the FDA was made much easier with the help of the Support Center, Dr. Patel said. “No matter how perfectly you run the trial, there are always going to be issues that come up. Letters of deficiency are issued and you have to respond to them. Having an experienced group like the Support Center was invaluable.”
Happily, the FDA audit process is over and Dr. Patel’s research focused on a spine surgery device continues. “Earlier I had utilized the Support Center for study monitoring and to develop standard operating procedures. I was grateful for that help, and later I was immensely thankful for the audit support.”
UCHealth Research Support Services Updates
1. Research Support Services (RSS) continues to refine the review and approval process. There are several changes implemented as of November 1 to continue streamlining processes as we prepare to move to a single campus process.
- You no longer are required to submit COMIRB/WIRB documents. This includes approval letters and consents.
- You are no longer required to submit is a contract. UC Denver will now be routing these documents to RSS.
- You will receive RSS approval packages without these documents. However, your study will not be built in EPIC until UC Denver has provided these.
2. With the new approval process, our approval letter has changed as well. Some of you may have received a new approval letter. Please make sure to read the letter and contact us if you have any concerns about what is required with Research Support Services approval.
We were very excited to announce the beginning stages of reporting capability with the research community. However, we ask for your patience as the IT department has notified of that there is a delay in completing the necessary infrastructure for these reports as they work hard down south with Memorial’s go-live. Please still send report requests to UCH-ResearchSupport@UCHealth.organd we will work on them as this infrastructure becomes available.
Be on the lookout
We have been working hard to develop new access to EPIC for research staff based on the over 200 responses provided to the survey back in September. We are happy to announce that we are close to rolling this new access out. There will be 3 levels of access:
- View Only- this access will not change from what is currently available
- Research Coordinator- this is our new level of access, things to look for are access to schedule patients, do phone triage notes, review and add allergies and medications and much more. We will have training before this access is released.
- Research RN- this access essentially will not differ but training will be different. RN’s with active licenses will receive the same training that all other RN’s receive and will be required to do an additional training to learn the specifics of research functionality within EPIC.
As part of your approval with UCH, you agree to associate all patient visits with the research study. Research Support Services builds these studies in EPIC to make this possible. If you do not find your study code in EPIC, contact Research Support Services right away.
- Remember-your study will only be built in EPIC if you have IRB approval and a fully executed contract.
School of Medicine - New Initiative to Facilitate Clinical Research
In an effort to serve the clinical researchers in each department better, the Department of Medicine has allocated funding for a 0.5 FTE to create the position of a Research Facilitator. The primary responsibility of this Research Facilitator will be to assist with the completion and perform pre-reviews of all required documentation prior to their submission to COMIRB. Our goal is to improve the quality of research applications, which in turn will speed up your IRB review and approval. The ideal candidate for this position is thoroughly familiar with COMIRB processes and requirements, and is willing to assist all faculty with the requirements of exempt, expedited and full board review research projects. The person in this position will work closely with and under the guidance of senior staff at the Clinical Research Support Center. Please forward this e-mail to anyone you think may be appropriate and refer anyone who is interested in hearing more about this position to Heike Newman.