Office Hours – Help with Submissions and Consent Forms
COMIRB Office Hours are a great way to receive help and guidance
with issues that could delay approval of your research. COMIRB Office
Hours are an excellent opportunity to find help with:
to Research Ad E-mailing by SOM’s Research Affairs Office
Research Affairs Office in the School of
Medicine has streamlined the email process for distributing research and
clinical trial ads. Previously, each study was emailed separately.
However, as the number of ads grew, so did the number of complaints about
overcrowded inboxes and heavy attachments. As a result, some people have
blocked all Research Affairs ads from their email accounts.
avoid losing more recipients, the Research Affairs Office has begun compiling
research and clinical trial ads into one daily
email that will supply a summary of that day’s trials. Each summary will
contain a link to a CU Denver clinical trials website displaying details about
can also be posted on the Research Affairs Office’s publically-accessible
clinical trials website, independent of the E-mail notice distributions.
How has the process changed for you for new studies?
Submit the ad to COMIRB as you normally would.
All information shown on the form must match the COMIRB ad exactly.
If you have a current ad running, there is no action required. We will simply switch from individual ads being sent to the summary show below.
email Brenda Crawford with
any questions about the change in email policy. Go to the Research
Affairs Website to see the current list of clinical trials.
Event and Noncompliance Reporting to COMIRB: new report forms
are often unsure of when reporting of adverse events and instances of
noncompliance need to be reported to COMIRB. Most
adverse events, noncompliance, and protocol violations need to be reported to
COMIRB at some point, but not all need to be reported within five days of
learning of them. Many events can be reported at the time of
general guideline is that adverse events which meet
the definition of unanticipated problems (are unexpected, related to the
research procedures, and caused harm or risk of harm) need to be reported
within five days. Other occurrences,
such as noncompliance, which signal an increase risk to participants also must
be reported within five days. If an event does
not meet the criteria for prompt reporting, it should be tabulated on an
aggregate reporting form for submission at the time of continuing review; these
aggregate reports allow the IRB to evaluate the PI's assessment of the ongoing
safety of the study. Note that if there is an independent safety monitor
for the study (e.g., Safety Officer, DMC, or DSMB), aggregate reports do not
need to be submitted at the time of continuing review. Instead, COMIRB
defers the ongoing safety oversight to this monitor, and a summary report from
the monitor should be submitted at the time of continuing review.
is pleased to announce the release of new forms to
help guide investigators in when submission of an untoward occurrence must be
made promptly. These forms, now available on the COMIRB web site,
New at UCHealth Research Support Services?
Be on the lookout:
When you are completing your UCH RSS application, please include ALL services the protocol requires, regardless of payer. This means both standard of care and non-standard of care should be accounted for on the application. You will not be expected to pay for items determined to be standard of care.
- Research Support Services at University of Colorado Hospital keeps the website up to date. Please make sure you are checking our website regularly for updated policies and forms. Our website can be found by going to: http://www.uch.edu/for-healthcare-professional/Research-Administration/