Welcome to The Compass newsletter, your source for all the news that is news at UCD’s new Clinical Research Support Center.
Support Center is the result of much thought and deliberation from
researchers and those who work closely with them. The goal for the
Support Center is to allow researchers to focus, as much as possible, on
the research they are doing. The Support Center’s creators at the
Office of Regulatory Compliance were concerned that the administrative
and regulatory burdens surrounding research were causing less research
to be accomplished at UCD and its partner organizations, and
causing researchers unnecessary headaches.
researchers are busy, and that reading wordy newsletters is not helpful.
So, in the spirit of the Support Center, The Compass pledges to be
brief, while also being informative. We’d love your feedback on the
Support Center, or this publication. Please send that to Molly Van Rheen
Celebrate our launch and meet the team!
The Support Center will celebrate its launch with six lunchtime meet-and-greet events from 12 pm to 1 pm at the locations listed below. Drop by to pick-up a snack and flier, meet the team, and learn more about the free assistance you can receive through the Support Center!
· 10/8: Building 500 cafeteria
· 10/9: Research 1 South Tower
· 10/16: Quad outside Fulginiti Pavilion
· 10/17: Research 2 lobby
· 10/23: Health Sciences Library coffee shop
· 10/24: AO1 lobby
UCHealth Research Support Services Update
Please check our website regularly. Many of the forms and documents you
use continue to be refined and improved!
A very big thank you to all of you who completed our survey on EPIC
Access! We had over 200 responses and are excited to review all of your
wonderful comments and suggestions. We look forward to updating you soon on
plans to implement changes based on your feedback.
Our new application is available on our website. We now have two different ways to complete the application. You can complete the word document and email it to us (as you have been doing). Or you can try our new Web-Based Smart Form! Be sure to check out our website for more information.
- Our monitor access form has changed. This form includes our faster turnaround policy (2 weeks advanced notice for EPIC Monitor Requests) as well as a new policy around paper charts. All paper chart requests for research purposes (monitors OR research chart review studies) must come through our central email with this new form. Please remember, paper charts need to be requested 5 business days in advance. If you have more than 100 charts that will need to be reviewed, more time will be required. Email us with any questions.
Be On the Lookout:
Research Support Services is now able to assist with research reports. Be on the lookout for more information on our website and how to request these services.
Questions & Answers Regarding Deloitte’s Work at CU
Question: I’ve heard Deloitte is doing a review to see how CU stacks up as a research institution, and how the University could improve its research output. How does this connect with what the new Clinical Research Support Center?
Answer: Deloitte has been contracted by the University to review the research being done here and to advise how to ensure the University remains a leader in this arena. The Support Center has a similar, if somewhat more narrow, goal. Our goal is to ensure human subject researchers have all the support they need in addressing the administrative burdens that are a part of conducting research.
Q: Is the report from Deloitte likely to lead to changes in how the Support Center does its work, or what services it offers?
A: It’s possible the Deloitte report, expected in the next few months, will suggest what additional steps the University could take to better support researchers with their administrative work. So, we anticipate we might be charged with doing even more for researchers. We are quite confident we won’t be asked to do less, since the University is looking for ways to secure more research funding and do more research.
Q: What additional support could be given to researchers struggling with IRB review, etc.?
A: The Clinical Research Support Center stops short of offering professional services to actually do the work required, for example, to secure IRB approval. We instead advise researchers and their coordinators how to do this work. A new Clinical Trials Office could provide researchers with administrative staff to help them with their review responsibilities.
The University of Colorado Denver seeks a Facilitator to work in the Clinical Research Support Center (CRSC) at the Anschutz Medical Campus in Aurora.
This position requires independent action, and the use of discretion and creativity within the limits of institutional, state and federal policies to facilitate the research mission of the University of Colorado. The position works extensively with individuals in all areas of the University and UCD affiliates to negotiate, influence and persuade other entities to collaborate with the Clinical Research Support Center to further the UCD’s research mission.
- This position is responsible for oversight of the following:
- Assists investigators and all members of the research team in the overall management of clinical research protocol documents and activity involving initial submission of new pediatric and adult protocols to COMIRB.
- Provides regulatory guidance and direction to investigators and all members of the research team in order to ensure compliance with all internal, external and federal policies including UCD and affiliates, FDA, OHRP, COMIRB, GCP and regulations that apply to research involving human subjects
- Assists in the development of policies and procedures for all tasks required for interactions with UCD, UCD Affiliates, CTSA, UCH, Children’s Hospital Colorado and federal agencies
- Demonstrates a strong understanding and working relationship with UCD, UCD Affiliates, CTSA, UCH, Children’s Hospital Colorado and federal agencies
- Assists investigators and their research staff who are conducting clinical trials to ensure protocols are in compliance with applicable local regulatory requirements, GCP guidelines and COMIRB requirements