November 8, 2013
Center Helps CU Spine Surgeon Survive FDA Audit
facing an audit, it’s nice to have professional resources to support you. Dr.
Vikas Patel, chief of orthopaedic
spine 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.
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
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.”
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.”
Research Support Services Updates
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.
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.org
and 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.
your study will only be built in EPIC if you have IRB approval and a fully
School of Medicine - New Initiative to Facilitate
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