In an effort to better meet the needs of investigators, COMIRB
will be reorganizing their administrative teams.
Up until now, minimal risk studies that were reviewed by a single
IRB panel member (expedited studies) were processed by a different administrative
team than those studies that presented more than minimal risk to subjects,
which required an entire panel of reviewers (full board studies).
Moving forward, all studies assigned to each of COMIRB’s 5 review
panels will be reviewed by a single administrative team (e.g., all studies
assigned to COMIRB Panel C will be processed by a single administrative team,
regardless of whether they require an expedited or full board review). Exempt
and non-human subject submissions will continue to be divided and processed by a separate team.
Investigators may notice some differences; for example, protocols
may be assigned to a panel with which investigators do not usually work. Please
pay particular attention to your feedback and approval letters to ensure that
you are contacting the correct team that is reviewing your study. Contact
information for all of COMIRB’s teams will soon be posted on their website.
As part of this reorganization, COMIRB is also creating a
dedicated investigator support team to assist investigators with the COMIRB
Though COMIRB feels that this will be a difficult transition
within their office, they are confident that these changes will ultimately
improve their ability to serve you. COMIRB greatly appreciates your patience as
they make this transition, and will work hard to minimize any disruptions.
Please feel free to contact COMIRB with any questions at
303.724.1055, or COMIRB@ucdenver.edu.
OnCore Testing In Motion
OnCore project team is currently in the process of performing various tests in
an effort to streamline and centralize the system’s functionality:
The first round of testing customized, drop-down menu “pick lists”
and underlying tables was completed on April 25. The second round of testing is
scheduled to start on May 14.
Testing is also in progress for the EPIC demographics interface
Biospecimen Module (BSM) training is scheduled to take place on
May 20 at the Anschutz Medical Campus. If you have specific questions about the
module, please contact Meg Rebull (firstname.lastname@example.org)
no later than May 16.
The following groups have volunteered to test run some of their
studies in OnCore once it has been implemented: Orthopedics, Renal Medicine and
Hypertension, Ophthalmology, and the Cancer Center GU group.
End-user training materials are currently being developed.
information is now available online! Visit www.ucdenver.edu/research, select
“Human Subject Research,” and click on the OnCore logo.
have any questions, you can reach a member of the OnCore support team by
emailing them at OncoreSupport@ucdenver.edu.
Updates from University of Colorado Hospital Research Support Services
a continued effort to improve EPIC access for research coordinators, RSS has
worked to add access to view all pended orders. Additionally, research staff
should have access to the smart tool manager, which will allow you to build dot
phrases outside of a patient encounter. This access is available now. If you
have any issues utilizing this new functionality, please contact RSS. A
‘How-To’ document will be posted on the website in the coming weeks.
the increased collaboration with UC Denver to provide RSS with IRB approval
information, RSS has removed the need to upload an IRB approval letter in the
UCH Badging Office has moved! Moreover, RSS is working with the badging office
to ensure that those who are approved for a badge receive it in a timely
manner. This means that there is no further need to complete an online badge
request. RSS will do this on your behalf and provide further instructions on
how to schedule an appointment and receive your badge. If you have questions
about this process, please contact Research Support Services.
Party Payers (including Medicare and insurance companies) may require
documentation of a patient’s involvement in a research study. In order to remain
compliant, please alert RSS to any requests you or your patients may receive as
soon as possible. RSS will work to obtain and release this information in a
studies (such as medical chart reviews) DO require RSS approval if you will be
accessing UCH’s electronic medical record to complete your study. Please
remember to complete the online application for these studies.
and bills are now being sent electronically in a modifiable format. Make sure
to check your inbox for this information. If you have any issues with the
invoices you receive, contact RSS.
your study involves a device, UCH may need to submit an application to Novitas
for approval. The submission to Novitas cannot be made until a study receives
IRB approval. There may be additional documentation, such as an FDA Un-redacted
Letter or post-market approval, as well. Novitas review and approval may take
up to 45 days; RSS will not activate a study in EPIC until Novitas approval is
received. RSS will post further guidance in the coming weeks.
on the Lookout:
an effort to work together with all departments, Research Support Services will
start requiring all study set up be complete before activating a study in EPIC.
This means that starting July 1st, RSS will require Pharmacy EPIC
Build, as well as CTO set-up and Radiology EPIC build (if applicable to your
study), before activating a study in EPIC. RSS will post a comprehensive guidance
on their website in the coming weeks.
Support Services is striving to minimize confusion around study builds in EPIC.
In order to be consistent throughout the Health System and in EPIC, “g-codes”
will be getting a facelift. RSS is working to standardize and align a “study
code” as a system-wide unique identifier. Look for coming details regarding the
new “study codes” in the next month.