Human Research

Human Research

Getting Started

Steps to starting your research project

Select lifecycle subphase below:

Research Lifecycle Orientation

Learn about the research lifecycle at the University of Colorado

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Training

Links to research administration training orientation and requirements
 

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Systems Access

Obtaining access to the applications used for research administration at the university

 

Contact Information

General Systems Access via Research Information Technology
For questions and support around InfoEd eRA System or eSirius access, please email era-access@ucdenver.edu
OnCore Support

Phone: 303-724-1111
Email: OnCoreSupport@ucdenver.edu
Available M-F 6am - 5pm

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Study Development

Developing study designs and analysis plans

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Identify Resource Needs

Space, equipment, personnel, shared resources/cores, facilities needs
 

Contact Information

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Budget Development

Developing your budget
 

Contact Information

Office of Research Development and Education

Denver Campus
1380 Lawrence Street, Suite 300, Denver, CO  80204

CU Anschutz
By appointment

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu
Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Draft Protocol

Creating your draft protocol
 

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Funding

Learn about funders and funding options for sponsored research

Contact Information

Office of Research Development and Education

Denver Campus
1380 Lawrence Street, Suite 300, Denver, CO  80204

CU Anschutz
By appointment

Essentials

Things to consider before starting your research project

Select lifecycle subphase below:

Study Design (Biostats, Funder Requirements, Data Storage, etc.)

Designing your study including bio stats, funder requirements, data storage, etc.

Contact Information

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Timelines & Requirements

Learn about timelines, deadlines and internal department processes and requirements

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Identify Staff Resources

Determining staffing needs and resources

Lab Assignment

Requesting lab facilities

CDA Approval

Obtaining a Confidential Disclosure Agreement
 

Contact Information

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Securing Funding

Funding information for Sponsored Research Projects

Select lifecycle subphase below:

Proposal Development

Developing your proposal

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Proposal Review

Internal and external proposal reviews

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Funders Proposal Requirements

Using funder/sponsor requirements when developing a proposal

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Proposal Submission to Funder

Submission process for funder/sponsor review

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Funding Approval

Obtaining funding approval, award process, requesting speed types

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Just in Time Requirements

National Institutes of Health (NIH), Just in Time (JIT) guidelines and requirements

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Research Approvals

Research Approvals required to conduct research at the University of Colorado Denver | Anschutz Medical Campus

Select lifecycle subphase below:

Approvals (Federal, Committee, Site)

Applying for Federal, Committee and Site approvals

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Training (Regulatory, Site)

Training required before application for approvals

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Resource Access & Assignments (Lab Assignment, Systems Access)

Obtaining access to applications used in research (InfoEd eRA System, OnCore, etc.) and obtaining lab assignment

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

OnCore Support

Phone: 303-724-1111
Email: OnCoreSupport@ucdenver.edu
Available M-F 6am - 5pm

General Systems Access via Research Information Technology
For questions and support around InfoEd eRA System or eSirius access, please email era-access@ucdenver.edu

Sign Agreements

Contracts, sub-contracts, MTA's, data use

Contact Information

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu
Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Financial Accounts

Financial account set-up

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Protocol Revisions

Making revisions based on committee feedback

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Submitting for Approval (Regulatory submissions)

Regulatory approval submissions

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Feasibility Assessment

Study feasibility assessment

Contact Information

Colorado Clinical and Translational Sciences Institute (CCTSI)

CU Anschutz
Leprino Building
12401 East 17th Avenue, 3rd Floor
Aurora, CO 80045

720-848-7100

Research Activity

Resources and guidance while research projects are underway

Select lifecycle subphase below:

Recruitment

Recruiting study participants

Contact Information

Colorado Clinical and Translational Sciences Institute (CCTSI)

CU Anschutz
Leprino Building
12401 East 17th Avenue, 3rd Floor
Aurora, CO 80045

720-848-7100

Procurement

Ordering supplies and equipment

Budget Management

Payments, tracking and reporting

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Regulatory Reporting

NHIS, FDA reporting, amendments and adverse events

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Inspections and Audits

Internal and external inspections and audits

Data Management

Experiment results and safety monitoring

Lab and Inventory Management

Management of supplies and facilities

Training (Continuing Education)

Links to research administration training orientation and requirements
 

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Clinical Research Support
Phone:  303-724-1111
Email:  ClinicalResearchSupportCenter@ucdenver.edu

Committee Approvals (Reviews, Amendments)

Maintaining ongoing committee approvals requirements

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Research Wrap-up

Information about wrapping up and closing out your research project

Select lifecycle subphase below:

Study Results

Finalizing study results

Financial Close-out

Fiscal reconciliation

Contact Information

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Committee Close-out

Closing studies with all committees

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Permit Close-out

Terminating permits

Inventory/Resource Close-out (Resources, Specimens)

Returning, releasing and/or storing resources and results (specimens)

Contact Information

Regulatory Compliance
CU Anschutz
Fitzsimons Building

13001 East 17th Place

W1124

Aurora, CO 80045

303-724-1010

Regulatory Close-out

Completing all regulatory reporting

Contact Information

COMIRB

Phone: 303-724-1055
Email: comirb@ucdenver.edu
Address: Anschutz Medical Campus
                 Fitzsimons Building (500)
                 3rd Floor North
                 Aurora, CO 80045

Grants and Contracts
Phone:  303-724-0090
Fax:       303-724-0814
Email:  xenia@ucdenver.edu
Address:
Grants and Contracts, Mail Stop F428
Anschutz Medical Campus, Fitzsimons Building (formerly Bldg 500)
13001 E 17th Pl, Room W1124
Aurora, CO 80045-2571

Data Sharing Dissemination

Publication and dissemination of study results

Data Close-out (Share/Lock, Analysis, Documentation, Secondary)

Finalizing data analysis, documentation, secondary use or locking