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University of Colorado Denver

 

June 2014

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


 

News from the Support Center: Quality Assurance Reviews

As part of the UCD Office of Regulatory Compliance's quality assurance efforts, the Clinical Research Support Center conducts not-for-cause (random) and for-cause Quality Assurance (QA) reviews of research involving human subjects conducted at the Anschutz Medical Campus, the Downtown Campus, and at some of our affiliate institutions. These QA reviews are intended to be an informative and educational experience, providing participants with practical guidance and tools for conducting their project.

The QA review process for not-for-cause reviews has changed from what investigators may expect or have experienced in the past. Because the purpose of QA reviews is meant to be educational and not punitive in nature, the new process now reflects that intent.

Three subject files will be selected at random for review, and findings (unless serious in nature) will be reported directly to the Principal Investigator, along with recommendations for further action. In the case of serious noncompliance, findings will be reported to the Office of Regulatory Compliance.

Please visit the Quality Assurance pages to see helpful links,

training opportunities, and templates.​

 


OnCore Testing Continues

The OnCore project team is continuing their efforts to troubleshoot and streamline the OnCore System:

·         The second round of testing customized “pick lists” and underlying tables was completed on May 30th. No major issues were found, and the Oncore support team will begin the final verification process on June 4th.

·         EPIC demographics interface integration has also been completed. The OnCore project team is working to complete the final round of finishing touches.

·        The Biospecimen Module (BSM) training occurred on May 20th.

·         The OnCore project team is now working with the Central Repository group to define the customized “pick lists” and underlying tables for the BSM module in Oncore.

·         Enduser training for the Early Adopter groups is scheduled for July 8 and 9, 2014.

Check for additional information online!

Visit www.ucdenver.edu/research, select “Human Subject Research,” and click on the OnCore logo.

If you 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 (RSS)

What’s New:

  1. University of Colorado Health has a new website. This means that the Research Support Services website has moved. You can find the new Research Support Services website by visiting https://www.uchealth.org/professionals/Pages/Research/UCH-Research-Support-Services.aspx
  2. RSS will be modifying the new study application to include location-specific questions. You may start to see some additional questions regarding location (e.g., North, Central, South) as they begin to roll the application out to all sites. RSS will continue to update the instruction sheet with any changes. If you have questions regarding the application, please contact RSS.

Don’t Forget:

  1. RSS is your “one stop shop” for data requests. If you would like data for an IRB and RSS-approved study, please contact RSS via email.
  2. RSS is responsible for all research new hire onboarding and orientation to the hospital. Please visit their website to access the materials for Study Team Credentialing and Onboarding.

Be on the Lookout:

  1. New Hospital Orientation coming soon! Research Support Services is excited to announce that starting in July, they will host an all-day orientation to the hospital that will include EPIC Training, EKG/Phlebotomy Training, RSS Orientation and more. All of this will be provided at no charge to the research community. New research hires will automatically be enrolled for this orientation once they submit their initial onboarding materials.
  2. Changes to EPIC will be coming soon. RSS is working closely with the EPIC teams to prepare for the EPIC 2014 Update that will occur in early 2015. With this update, there will be many research upgrades. RSS will provide more information closer to the “go-live” date.
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