1. Human Subject Research Portal
Children's Hospital Colorado

2. A new, online "one stop shop" site where researchers, study coordinators and others involved in human subject research can easily navigate the project approval process.
This single entry portal will eliminate redundancy and avoid confusion for those engaged in Human Subject Research.
What is it?

3. Portal Overview

4. Which institutions will use the portal?
Piloting the process
University of Colorado Hospital
Children’s Hospital Colorado
UCDenver
Clinical and Translational Research Center (CTRC)
Existing Process
Veteran’s Administration
Denver Health
National Jewish (non CTRC)
Boulder (non CTRC)

5. Which protocols will use the portal?
All Submissions: Industry, federally funded and internally funded, (including Expedited, Exempt, Non Human Subject Research)
University of Colorado Hospital
Federally funded, Investigator-Initiated, Industry Funded (Full Board only)
Children’s Colorado
Federally funded or Investigator-Initiated (Full Board)
UCD Only
All protocols requesting use of CTRC resources
CTRC
Aim is to eventually have all studies using the portal at this point each institution is piloting If you are unsure follow submission instructions which will assist in making this determination.

6. Which protocols will require Scientific Review?
Investigator-Initiated, Internally funded
Some foundation funded studies (if not peer-reviewed as part of the funding process)
Federally reviewed grants (including training grants) where the science has significantly changed since the grant was peer-review

7. Which protocols will not require Scientific Review?
Industry Funded (protocol funded and owned by industry)
Multisite Studies (where UCD is not the lead site)
Those that receive FDA review as part of an IND or IDE clearance
Federally funded grants (not including training grants) where the science has not significantly changed since the review

8. Advantages Facilitates parallel submission
Single feedback letter which avoids conflicting requests for changes
Tracks submission timelines and deadlines
Reduces the complexity of navigating the current protocol approval process
Advantages