Human Subject Research (HSR) Portal
Begin the process protocol for assessments or amendments going to external IRBsFind the regulatory administrative tool right for your project
Clinical Research
The Clinical Research Administration Office (CRAO) guides investigators through regulatory requirements for human subject research (HSR). Begin processes for studies going to an external IRB via the HSR Portal and indicate which IRB will be used within the portal. CRAO and the Clinical Research Support Team (CReST) supply study coordinators and regulatory staff to support investigators from study start-up through closeout.
Clinical Research Agreement Portal
MTAs, CDAs, certificates of confidentiality and dB gap agreementsExternal IRB
Protocol Assessment or Amendment FormProposal Continuation Form
Contract amendments, IPA/JPA modifications or continuation LOIsCReST Request Form
Tell us about your project, and we will set up a meeting.The Investigational New Drug and Device team (IND/IDE) facilitates innovative advancement through expert support and collaboration managing administrative, regulatory and safety elements of the product development lifecycle.
Triage Intake
Complete an FDA IND/IDE formSingle Patient Protocol
Request a record for an IND or IDEColorado Multiple Institutional Review Board (COMIRB) and External IRB review human subjects research work to ensure regulatory, ethical and institutional compliance and participant safety. The Conflict of Interest (COI) team reviews annual disclosures to identify conflicts. The InfoEd Electronic Research Administration (eRA) System manages the research lifecycle and helps researchers submit grants and contracts, human subjects protocols and their COI disclosures.
COMIRB InfoEd Portal
COI InfoEd Portal
Data Sharing Requests
For submission of data-related requests; includes a field for notes/helpful information and a field to upload documents for review by the team. Submissions here prompt a response to your request from the Office of Regulatory Compliance.
Data Sharing Request Portal
Business associate, data use and data transfer agreementsHealth Safety and Animal Research
Access services of The Office of Laboratory Animal Resources and Environmental Health & Safety. Note: To use eSirius, researchers must be on campus or VPN to submit a protocols.
IACUC Submission via Cayuse
Institutional Animal Care and Use CommitteeVivarium Access
Process to work with animals in researchIBC Submission via Cayuse
Institutional Biosafety CommitteeRadiation Safety Application Forms
CIR huCIR RDRC Submissions
More Resources
Office of Grants and Contracts
Intellectual Property Variance
For agreements with patents, copyright or IP concessionsResearch Resources Directory
| Need to Contact a Team? | Email Us |
| COMIRB | comirb@cuanschutz.edu |
| Clinical Research Administration | ClinicalResearchSupportCenter@ucdenver.edu |
| Clinical Research Support Team (CReST) | CReST@ucdenver.edu |
| EHS Services | Various emails |
| EHS Team | Various emails |
| External IRB | externalirb@ucdenver.edu |
| Institutional Biosafety Committee | ibc@cuanschutz.edu |
| Investigational New Drug & Device Team (IND/IDE) | ind.ide.office@cuanschutz.edu |
| Technology Transfer Team | ttocontact@ucdenver.edu |
| Regulatory Compliance | |
| Team members | reg.compliance@cuanschutz.edu |
| Subcontracts | |
| Awards Intake Team | ogc.awardsintake@ucdenver.edu |
| Procurement Service Center (PSC) | finprohelp@cu.edu |
| Status on speedtype and data sharing requests | ogc.4status@ucdenver.edu |
| Subcontracts Team | ogc.subcontracts@ucdenver.edu |
| CU Medicine | |
| Contracts Team | contracts@cumedicine.contractlogix.com |