Submission Type:* must provide value
New submission
Submission for exemption from Group restrictions for a protocol previously approved through the research reactivation portal
New submission with request for exemption
Which group do you believe your study falls into? Group 1 Group 2a Group 2b Group 2c Group 2d Group 2e Group 2f Group 2g Group 3a Group 3b Group 3c Group 3d Group 3e Group 3f Group 3g Group 3h Group 4a Group 4b Group 4c Group 4d Group 4e Group 4f Group 5a Group 5b Group 5c Group 5d Group 5e
For what group are you currently approved? Group 1 Group 2a Group 2b Group 2c Group 2d Group 2e Group 2f Group 2g Group 3a Group 3b Group 3c Group 3d Group 3e Group 3f Group 3g Group 3h Group 4a Group 4b Group 4c Group 4d Group 4e Group 4f Group 5a Group 5b Group 5c Group 5d Group 5e
Name of person completing this survey* must provide value
Email address of PI* must provide value
Check all locations where the research protocol will be implemented* must provide value
AMC (including UCH)
CHCO
For CHCO studies, only select AMC if study activities will occur on AMC outside of CHCO buildings
If the group the study falls under is not yet being reviewed for the site, or the space requested is not open, this application will not be approved at this time. Please reference https://www.cuanschutz.edu/coronavirus/research-guidance for more information.
Where on AMC? UCH
UCH CTRC Inpatient
UCH CTRC Outpatient
UCH Perinatal CTRC
BDC
CU Medicine Building (UPI)
Anschutz Health and Wellness
Fitzsimmons/Bldg 500
Other
For studies that are only using UCH resources (i.e. no CTRC, CHCO or other AMC resources) do not submit this form. Submit to the UCH research administration central box instead.
For studies that are only using UCH resources DO NOT submit this form. Submit to the UCH research administration central box instead.
If other location, please specify
Are all procedures happening at UCH? Yes
No
Is this a CTRC protocol?Please note, if you are requesting a room in CTRC but not CTRC services please select "Yes" to this question.
* must provide value
Yes
No
Are you submitting for multiple protocols?* must provide value
only 1 protocol
multiple protocols
Has this protocol been previously implemented at this site? No, this is a new protocol
Yes, previously implemented
Please upload an Excel document with a list of protocols with IRB number, PI name, contact information and the group you are applying for here (Please use template below)
Please use this template spreadsheet for submitting multiple protocols PI First Name* must provide value
PI Last Name* must provide value
IRB Number (This must be entered as a number in this format: XX-XXXX)* must provide value
CHCO Section/Department (Primary section/department appointment of PI)* must provide value
Adolescent Medicine Allergy and Immunology Anesthesiology Cardiology Child Abuse and Neglect Critical Care Medicine Dermatology Developmental Biology Developmental Pediatrics Emergency Medicine Endocrinology Gastroenterology, Hepatology and Nutrition General Pediatrics General Surgery Genetics and Metabolism Hematology, Oncology and BMT Infectious Disease Informatics and Data Science Maternal and Fetal Medicine Neonatology Nephrology Neurology Nutrition Orthopedics Pediatric Hospital Medicine Pediatric Pulmonary and Sleep Medicine Radiology Rheumatology Other
If other CHCO department, please specify
CHCO Study Visit Locations (please select all that apply)* must provide value
CTRC Outpatient
CTRC Inpatient
CTRC Perinatal
Non-CTRC Outpatient-OP Pav Level 1
Non-CTRC Outpatient-OP Pav Level 2
Non-CTRC Outpatient-OP Pav Level 3
Non-CTRC Outpatient-OP Pav Level 4
ED/Urgent Care
Inpatient
OR
Procedure Center
Radiology
Outpatient Lab
Pathology Lab
Health Pavilion
CHCO services required during visits (Please select all that apply) * must provide value
Investigational Drug Services (IDS)
Radiology
NDRC
CHCO Clinical Lab
CCBD
Epilepsy Monitoring
Procedure Center
Cardiology/EKG
Sleep Studies
None of the listed services are needed
Are biospecimens being collected?* must provide value
Yes
No
If yes, are the biospecimens staying within the facility of collection? Yes
No
If no, where will they be delivered to? RC1
RC2
Leprino
BDC
Anschutz Health and Wellness
Other
Shipped to an external, non-AMC location
If the specimens will be processed or stored in an AMC building outside of the location it is collected, please select 'AMC' in the location above
If other, please specify
Are you requesting access to other facilities? (e.g. AO1, RC1, RC2, etc.)* must provide value
Yes
No
Which facilities will you need access to?
CHCO
UCH
RC1
RC2
Leprino
CTRC Core Lab
BDC
Anschutz Health and Wellness
AO1
ED2
Other
Please specify other facility needing access to
Is this an Oncology study?* must provide value
No - Not an oncology study
Yes - UCH/AMC Oncology Study
Yes - CHCO Oncology Study
Yes - Both UCH/AMC and CHCO Oncology
Please indicate from where PPE will be provided:* must provide value
Study sponsor
Facility (e.g. hospital, clinic)
AMC
Other entity
No PPE is needed
Specify quantity of PPE required
Please specify other entity providing PPE
Who is the COVID space official? (First Name Last Name)
COVID space official email address
What changes have been made to minimize face to face contact and/or accommodate ongoing protocol visits?* must provide value
eConsent
Phone
Video chat
Tele-health
Email
Other
None
Please list each change you have made or will make, with rationale, if necessary
Priority Ranking definitions Please indicate for which group you are submitting this protocol for consideration.
* must provide value
Group 1 Group 2a Group 2b Group 2c Group 2d Group 2e Group 2f Group 2g Group 3a Group 3b Group 3c Group 3d Group 3e Group 3f Group 3g Group 3h Group 4a Group 4b Group 4c Group 4d Group 4e Group 4f Group 5a Group 5b Group 5c Group 5d Group 5e
See attached guidance for more information
Please describe why this protocol belongs in this group by indicating the exact wording from the framework and justify why it meets this criteria.* must provide value
Do you have patients already enrolled? Yes
No
Are you looking to enroll new patients? Yes
No
How many subjects will you be seeing?
Did this study receive previous authorization as essential research through the Office of Regulatory Compliance during the COVID shutdown? Yes
No
Please upload a schedule of events
Changes to the protocol need to be indicated on the schedule of events
This is required if a schedule of events is not clearly delineated in the protocol
Please upload the protocol * must provide value
Exemption request based on: Small number of visits
Prevention studies (4e, 3d)- Use when SOC is not effective for this population or individual participant. Not to be used if the study requires research only visits at baseline or follow-up time points, with limited exceptions.
Limited window of enrollment/timeline limitations
All research procedures can be performed/completed by staff/providers already involved in SOC visit
Other
How many total study visits are you requesting and in what time frame, inclusive of all participants needing study visits?
Please provide detail on why these study visits should occur. If applicable, note whether any visits are via telehealth, whether visits occur during SOC and how many staff are needed to complete these visits. (Only include staff not involved in SOC visits).
Please describe in detail how SOC is not effective for this population or individual participant. Details could include information on level of disease severity of participants, limitations of current SOC, and potential added benefit to participants.
Please provide detail on the limited window of enrollment or timeline issues e.g. what is the window, who set it, what factors contribute to your timeline issues, e.g. funding constraints, specific protocol issues, training timeline. Also, please detail what the impact of a 2 month delay would be.
Is this a career development project? Yes
No
Is the PI a trainee? Yes
No
If yes, which type Post-doc
Fellow
Other
If other type, please specify
Please provide detail on how you will implement your protocol with only staff/providers already involved in SOC visits.
Please provide additional detail on why you think your protocol should be exempted from the current campus guidelines.
Please upload any other supporting documents (e.g. cover sheet or other justification documents)
Imported Record Yes
No
Submit
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