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Human Subject Research Portal

Human Subject Research Portal. Children's Hospital Colorado. What is it?. 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 .

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Human Subject Research Portal

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  1. Human Subject Research Portal Children's Hospital Colorado

  2. What is it? • 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. www.UCDenver.edu/HSRPortal

  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? 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 • Investigator-Initiated, Internally funded • Some foundation funded studies (if not peer-reviewed as part of the funding process) • Federally reviewed grants (including training grants) where the science has significantly changed since the grant was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

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