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University of Colorado Denver

 

January 2014

All the news that is news at the Clinical Research Support Center


COMIRB 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:

  • Completing submissions to COMIRB, especially Initial and Continuing Reviews. Detailed guides on how to complete submissions to COMIRB can be found here.
  • Writing Consent Forms. The Clinical Research Support Center has staff available to assist with this challenging step to gaining approval for your research.

Changes to Research Ad E-mailing by SOM’s Research Affairs Office

The 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.

To 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 each study.

Ads 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.
  • Once COMIRB has approved the ad, submit this Clinical Trials Participants Advertisement Form and send a copy of the ad to Brenda Crawford.
  • 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.
 

Please 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.


Adverse Event and Noncompliance Reporting to COMIRB: new report forms
Investigators 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 continuing review.
 

The 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.

COMIRB 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, include:
 

What’s New at UCHealth Research Support Services?
 
  • New EPIC access for research staff will be released this month. Make sure to keep an eye out for more information about how to obtain this access.
  • A new federal regulation has come out that requires that the National Clinical Trials (NCT) Number be included on bills going to Medicare. To remain compliant, University of Colorado Hospital Research Support Services will require the NCT # on applications (when necessary). To find the NCT #, you can either ask your sponsor or look it up at clinicaltrials.gov

Be on the lookout:

  • PRA Credentialing and Monitor Access will be moving to an online submission form soon. Be sure to look for UCH RSS’s email with more information.

Don’t Forget

  • 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/
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