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* must provide value
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
Additional email address(es) to be notified of submission.
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
Additional email address to be notified of submission.
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
Additional email address to be notified of submission.
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
Additional email address to be notified of submission.
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
Additional email address to be notified of submission.
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
Additional email address to be notified of submission.
This email address must be a UCHealth, CHCO, Denver Health, or CU Anschutz email.
IRB (COMIRB) Number (xx-xxxx):
* must provide value
Is this submission an amendment?
* must provide value
Yes
No
Is this an internal amendment?
(note: internal submissions are entered by UCHealth research administration, DHHA SPARO, or Children's Hospital Colorado research administration employees ONLY.)
If you select YES, your amendment will not be processed.
* must provide value
Yes
No
This is intended to identify amendments submitted by system level UCHealth Research Administration or DHHA SPARO staff.
Institution submitting the internal amendment
* must provide value
UCHealth Research Administration DHHA SPARO Children's Hospital Colorado (CHCO)
Does this require calendar changes by the PA?
* must provide value
Yes
No
Amendments that would require a PA include changes needed to scheduling, new calendar procedures, or removing calendar procedures, or involve changes to budget only procedures
Please log-in to OnCore and confirm that your staff list for this protocol is up-to-date so that the appropriate staff receive all necessary notification and signoff emails.
IMPORTANT: DO NOT ENTER SUBJECT VISITS UNTIL YOU HAVE RECEIVED IRB APPROVAL OF THIS AMENDMENT AND THE CLINICAL RESEARCH MANAGER CONFIRMS THAT THE UPDATED CALENDAR AND/OR FINANCIALS HAVE BEEN RELEASED AND THAT ALL ACTIVE SUBJECTS HAVE BEEN MOVED TO THE NEW VERSION.
FAILURE TO FOLLOW THESE INSTRUCTIONS WILL RESULT IN SIGNIFICANT TIME FOR THE STUDY TEAM TO DELETE INCORRECT VISITS AND RE-ENTER.
Which sites does this study currently utilize?
( Choose all that apply . If you don't remember, log-in to OnCore and check the Institutions Tab.)
* must provide value
If you don't remember, log in to OnCOre and check the Institutions Tab.
Is this amendment to request changes to the release of study documentation in CHCO's Epic?
* must provide value
Yes
No
This may only be requested for studies under a waiver of parental consent or that are blinded. For more details, please see:
Release of Information Please indicate why you are requesting a change to the release of information timing:
* must provide value
Waiver of Parental Consent Blinded Study (Single or Double) Open-Label Extension Study Other
Please list the IRB# of the associated blinded study and any other related Open-Label extension studies that need to maintain blinding.
Please describe other reason for requesting an exception from release of information timing:
* must provide value
Not applicable for submissions after 6/5/2024. displayed only for redcap admins on historical surveys. not displayed on submission survey
Please select the type of change (check all that apply):
* must provide value
Amendment Type of Change
Hospital, Clinic, or CTRC CORE services option:
Select 'Yes' to Hospital, Clinic, or CTRC CORE services if any of the following : - adding new services or adding procedures to existing services (eg. Adding additional scan type (CT vs MRI) or body region) - update to imaging manuals - update to lab manuals - update to Beaker Build Requisition contacts CHCO ONLY
Select 'No' to Hospital, Clinic, or CTRC CORE services if ONLY the frequency of items/services that are already approved are being modified
effective 6/5/2024 only shown for redcap admins. question is not asked on survey submissions
Is the initial OnCore build completed?(Note: If your protocol is not yet Open to Accrual in OnCore, the answer to this question is "No")
* must provide value
Yes
No
Are you requesting corrections to a released OnCore calendar and/or budget?
How do you know if your specifications are released? In OnCore, Go to Menu > Financials > Financial Console > Subject Related.
As shown in the picture, this is an Unreleased Budget
* must provide value
Yes
No
Please provide in detail the corrections to the calendar/financials.
* must provide value
Which site are you requesting be removed from the study?
* must provide value
Is this submission only to submit an investigator's brochure (IB)?
* must provide value
Yes
No
Protocol amendment or clarification letter (include version and date):
* must provide value
Protocol type
* must provide value
Investigator initiated, multi-site, local site is not the lead site (including cooperative groups)
Investigator initiated, local site is the lead site
Industry Initiated
Protocol amendment number and date
* must provide value
Are you adding perinatal as a service or expanding the subject population to include neonates or pregnant women
* must provide value
Yes
No
Please submit your contract amendment via the University formstack here .
Please submit your contract amendment via the UCHealth short form here .
Please select which type of financial changes are needed in OnCore (select all that apply):
* must provide value
You have selected only an update to protocol related fees. These changes can be made in OnCore by study team members. Please email OnCoreSupport@ucdenver.edu if you have questions on how to update protocol related fees in the Financials Console.
Describe changes in detail to the budget/contract
Does the protocol amendment include changes to the schedule of events?
* must provide value
Yes
No
Describe changes here including page numbers and upload summary of changes.
Reference to internal forms (eg: IPAR) is not adequate. All financial changes that do not coincide with a protocol/calendar change should be outlined specifically.
* must provide value
Does this study evaluate a cancer-related question or population on the AMC, or receive funding from the University of Colorado Cancer Center?
* must provide value
Yes
No
Due to the nature of this amendment, approval by PRMS is required before the Clinical Research Administration Office can begin working on the change. Please submit to
PRMS and use the save and return option to complete this form once PRMS approval is received.
Is this a Gene Therapy, Cell Therapy, or Antisense Oligonucleotide (ASO) study?
* must provide value
Yes
No
Is this study managed by the Colorado Child Health Research Institute (CCHRI)?
* must provide value
Yes
No
Are you adding one of the below sites to an IRB-approved protocol?UCHealth Metro Denver (includes University of Colorado Hospital) UCHealth Northern Colorado UCHealth Southern Colorado Children's Hospital Colorado and/or CHCO CTRC CU Medicine Clinics
CU Anschutz Free Standing Research Facilities Denver Health
or other sites
* must provide value
Yes
No
Please select which of the following sites you are adding:
Note: Select CU Medicine Clinics for the Outpatient Adult CTRC
* must provide value
Is this amendment adding any CHCO-affiliated sites outside of the Anschutz campus (e.g. Network of Care sites, etc.)
* must provide value
Yes
No
Please indicate which affiliates sites you are adding to this protocol:
* must provide value
Please note: If you are selecting Inverness and intend to use UCHealth imaging/clinics, please select UCHealth Steadman Hawkins Clinic - Denver. If you are also utilizing the CU Ortho clinic at that location, please also select CU Medicine Clinics > CU Sports Medicine.
UCHealth Northern Colorado
* must provide value
UCHealth Southern Colorado
* must provide value
Industry Initiated, Investigator Initiated, or Cooperative Group Protocol? (If the protocol has industry funding but was written by the investigator, then the protocol is NOT industry initiated.)
* must provide value
Industry Initiated Investigator Initiated Cooperative Group
Investigator Initiated includes protocols that are NIH Consortiums or NIH funded to an external site
Email address to receive hospital invoices:
* must provide value
This person will receive invoices from UCHealth.
UCD AMC / CU Medicine clinics/research sites
* must provide value
CU Anschutz Free Standing Research Facilities
Note: Select Department Specific study site when you are enrolling non-patients such as community members, caregivers, or providers.
* must provide value
New Research Location:
* must provide value
Is this amendment ADDING any of the following (Select all that apply):
* must provide value
Is this study already using CHCO CTRC Nursing services?
* must provide value
Yes
No
Is this amendment adding any NEW CHCO Ancillary Services?
* must provide value
Yes
No
Is this amendment requesting CHANGES TO EXISTING CHCO Ancillary Services?
* must provide value
Yes
No
Are you adding a new research location not listed above?
* must provide value
Yes
No
Please describe what part of the study subjects are currently in. If this amendment does not affect the entire protocol calendar the OnCore calendar builders will only update the part of the calendar that is still needed. (For example: subjects are on treatment visit and this amendment only affects the screening visit, Therefore the builders would not make changes to the calendar)
* must provide value
What is the current protocol status?
* must provide value
Not yet open to accrual Open to accrual, Enrolling Closed to accrual Suspended
Does this amendment change the patient care services provided (i.e., labs, procedures, exams, imaging, etc.)?
* must provide value
Yes
No
Do you currently use Adult CTRC resources?
* must provide value
Yes
No
Does this change affect Adult CTRC services?
* must provide value
Yes
No
Are you adding Adult CTRC services with this amendment?
* must provide value
Yes
No
Please specify the changes to Adult CTRC services:
* must provide value
Please select which of the following Adult CTRC services you intend to utilize:
* must provide value
Specify location(s) of your research visits (check all that apply)
* must provide value
Will your study utilize CTRC Mobile Nursing Services?
* must provide value
Yes
No
A medical provider with admitting privileges at UCH is needed for Inpatient CTRC visits. Please specify the provider name.
* must provide value
A medical provider is needed for medical oversight of the study activities and to sign the nursing orders for AHSB CTRC OP clinic . Please specify the provider name.
* must provide value
Specify the location(s) for mobile nursing.
* must provide value
What Mobile Nursing Services will you use?
* must provide value
Specify what other services CTRC mobile nursing will provide?
* must provide value
Indicate if you will be using any of the commonly requested nursing procedures (check all that apply)
* must provide value
History and Physical Exam
* must provide value
CTRC APP as primary
Study Physician/APP only
Study Physician/APP as primary w/ CTRC APP as back-up
Vitals
* must provide value
CTRC Nursing as primary
Study Team only
Study team as primary w/ CTRC Nursing as needed
Phlebotomy
* must provide value
CTRC Nursing as primary
Phlebotomy Certified Study team member (Outpatient only)
Certified Study team member as primary w/ CTRC Nursing as needed
Sample processing
* must provide value
Study Team
CTRC Core Lab (AHSB)
UCH Clinical Lab (Beaker build required)
CTRC Nursing (Inpatient only
CTRC Nursing as primary
Study Team only
Study Team as primary w/ CTRC Nursing as needed
Medicine Administration
* must provide value
CTRC Nursing as primary
Licensed Study team member only
Licensed Study team member as primary w/ CTRC Nursing as needed
Comments or notes on Adult CTRC services
Please note the CTRC cannot perform the following labs: CBC CMP ALT AST Arterial Blood Gas Venous Blood Gas Hepatitis B Virus Quantitative by PCR Lactate Dehydrogenase – LDH Gamma Glutamyltransferase - GGT
Specify the assays you would like the CTRC lab to run:
* must provide value
Check all Core lab services that apply:
* must provide value
Are you adding additional UCHealth clinical departments or services to an existing protocol?
* must provide value
Yes
No
You have indicated you would like to add UCHealth to your study. Please describe the activities that you wish to take place at UCHealth, for example, enrollment requests, clinic visits, lab, radiology, and/or pharmacy elements.
* must provide value
Does the site addition change or add any UCHealth clinical services?
* must provide value
Yes
No
Which UCHealth departments are you adding?
* must provide value
Protocol Version Number and/or Date:
* must provide value
Must match the Study Title entered in the IRB of record
Please enter your Short Title below with the following format: "Intervention/ comparator/ study design" IN "treatment/ prevention/ evaluation" OF "target population/ disease/ condition" Ex: Baroreflex activation therapy in treatment of heart failure (BeAT-HF study)
Short Title
Please note: The short title may be displayed to participants in UCHealth My Health Connection. 100 character limit.
* must provide value
Check all sites where visits, recruitment or study interactions will occur.
* must provide value
Please select all that apply.
Are you requesting to use services at the CHCO CTRC?
* must provide value
Yes
No
CU Anschutz Free Standing Research Facilities Select Department Specific study site when you are enrolling non-patients such as community members, caregivers, or providers.
* must provide value
Will the scans at the Brain Imaging Center (BIC) be read by the CU Medicine Radiology team (e.g. for incidental findings or safety read)?
* must provide value
Yes
No
THIS REQUIRES THE CU Medicine BIC WITH SAFETY READ STUDY SITE
To ensure billing compliance, you will register subjects that are seen at the BIC with the demographcis feed in OnCore using MRN found in UCHealth's instance of Epic used by CU Medicine to order the read.
THIS REQUIRES THE CU Anschutz institution with BIC STUDY SITE
Other Site(s):
* must provide value
Does this study evaluate a cancer-related question or population on the AMC, or receive funding from the University of Colorado Cancer Center?
* must provide value
Yes
No
ONLY AVAILABLE TO ADMIN USERS. NOT FOward facing effective 3/13/24
Does this study involve blood draws; tissue collection; clinical procedures; clinical interactions; the administration of any drug, device, or biologics? Please select "No" when participant interaction is limited to the following: consenting, interviews/focus groups, and/or the administration of questionnaires/surveys.
* must provide value
Yes
No
Does any investigator have an appointment at DHHA?
* must provide value
Yes
No
DENVER HEALTH
ALL UCHEALTH PROTOCOLS
Retrospective data studies that wish to use Epic as a source for data may only select sites at which the study team physically works. for all other study types, select all sites where visits, recruitment, and/or study interactions will occur. THIS IS A DUPLICATE
ALL UCHEALTH PROTOCOLS Retrospective data studies that wish to use Epic as a source for data may only select sites at which the study team physically works. For all other study types, select all sites where visits, recruitment, and/or study interactions will occur.
UCHealth
* must provide value
UCHealth Metro Denver
* must provide value
Please note: If you are selecting Inverness and intend to use the CU Ortho clinic at that location, please select CU Medicine Clinics and CU Sports Medicine instead.
Will your study be conducted in the Internal Medicine - Anschutz, Internal Medicine - Cherry Creek, Internal Medicine - Lowry, WISH Anschutz, and/or WISH Park Meadows clinics?
* must provide value
Yes
No
Summary of services to be provided in WISH clinic(s):
* must provide value
Please provide the names of study staff other than the PI who may provide or contribute to the services (e.g. PRAs):
* must provide value
UCHealth Internal Medicine WISH Clinics required statement of work.
UCHealth Northern Colorado
* must provide value
UCHealth Southern Colorado
* must provide value
How will you obtain retrospective data for your study?
* must provide value
Please describe the treatment relationship with potential participants at UCHealth.
* must provide value
Will you be posting research study flyers in a UCHealth facility?
* must provide value
Yes
No
Which adverse event term set does this study follow?
* must provide value
CTCAE5.0 NIAID MEDDEV 2.7/3 Protocol-derived N/A
CHILDREN'S HOSPITAL COLORADO (CHCO)
Will your study utilize any CHCO-affiliated sites outside of the Anschutz campus (e.g.Network of Care sites, etc.)
* must provide value
Yes
No
Please indicate which affiliate sites this study will utilize:
* must provide value
Currently the infrastructure to conduct research at Children's Hospital Colorado, Colorado Springs is limited, and some types of research cannot currently be conducted there. If you are planning to utilize Children's Hospital Colorado, Colorado Springs as a site for your research, please contact Erin Sandene, (erin.sandene@childrenscolorado.org) to discuss the details of your project and assess its feasibility.
Will you require any Colorado Child Health Research Institute (CCHRI) operational support?
* must provide value
Yes
No
Select which CCHRI operational support services you plan to utilize:
* must provide value
Please indicate which team is coordinating this study:
* must provide value
Other CCHRI - CCBD BMT/CT CCHRI - CCBD COG CCHRI - CCBD ETP CCHRI - CCBD Hematology CCHRI - CCBD NeuroOncology CCHRI - CCBD Surge CCHRI - Neuromuscular CCHRI - Neuroimmunology CCHRI - CFCC CCHRI - Epilepsy CCHRI - Neurogenetics CCHRI - Developmental Peds CCHRI - Rehab CCHRI - Headache CCHRI - Digestive Health Institute CCHRI - Heart Institute CCHRI - Infectious Disease CCHRI - Clinical Nutrition CCHRI - Dermatology CCHRI - Endocrinology CCHRI - Ophthalmology CCHRI - Genetics CCHRI - Allergy/Immunology CCHRI - Radiology CCHRI - Specialty Care CCHRI - Child Life CCHRI - Nephrology CCHRI - Orthopedics CCHRI - Rheumatology CCHRI - Urology
Please indicate the other coordinator team
* must provide value
Please indicate which CCBD Regulatory Team is responsible for this study:
* must provide value
BMT/CT COG ETP Hematology NeuroOncology Surge NA Other
Please indicate the other CCBD regulatory team:
* must provide value
Is it possible you will be enrolling study patients/families who communicate in a language other than English?
* must provide value
Yes
No
As part of our efforts to promote diversity, health equity, and inclusion (DHEI) in clinical research, we have created a DHEI resource in the form of a Checklist for Protocols to help guide study team conversations about DHEI concepts related to your protocol. Please indicate your interest in learning about this Checklist.
* must provide value
Yes, we would like to talk with a member of the DHEI in Research Committee about the checklist.
We would like an email with more information and contact information for the DHEI in Research Committee
Not at this time. (If you should wish to learn more in the future please contact DHEIresearchcommittee@childrenscolorado.org)
Will this study ONLY use existing medical records, existing samples, or data collected for another purpose (e.g. secondary use of clinical data)?Note: If this study involves patient/subject interaction, please select "No".
* must provide value
Yes
No
Will this research involve any interactions with patients under the age of 18 (interactions include: surveys, focus groups, interviews, and any other kind of interventional or observational interaction prescribed by the protocol)?
* must provide value
Yes
No
Are you requesting a change to the timing of release of information?
* must provide value
Yes
No
This may only be requested for studies under a waiver of parental consent or that are blinded. For more details, please see:
Release of Information Please indicate why you are requesting a change to the release of information timing:
* must provide value
Waiver of Parental Consent Blinded Study (Single or Double) Open-Label Extension Study Other
Please list the IRB# of the associated blinded study and any other related Open-Label extension studies that need to maintain blinding.
* must provide value
Please describe other reason for requesting an exception from release of information timing:
* must provide value
Will you need to schedule a clinical room specifically for research visits as a part of this study?
* must provide value
Yes
No
If your visits will be done at the same time as a clinical visit you do not need to separately schedule a clinical room. Only select "Yes" if you will be scheduling rooms for stand-alone research visits.
Will this study require any of the following (Select all that apply):
* must provide value
Do you need a cost estimate for data extraction, database development, or other Research Informatics services?
Yes
No
Do you need data or informatics consultation for any of the following?
Do you need any of the following services?
Please describe the other research informatics services that you need
If you request assistance with database development we recommend using REDCap. Visit the CCTSI website for information on training. If you are interested in a REDCap consult or are requesting REDCap build from Research Informatics, please enter a Request using the Quick Link on My Children's or click
here .
If REDCap will not fulfill your database needs, please contact Research Informatics at ResearchInformatics@childrenscolorado.org to discuss additional options.
Please check out the Analytics Catalog in Epic for reports or extracts that may already exist to meet your needs. You can find this by typing 'Analytic' in the Epic search bar.
If you are not able to find what you are looking for or you are requesting Epic-REDCap integration or data from a research network, please enter a Request using the Quick Link on My Children's or click
here .
Please list the name of the NEW Principal Investigator below.
Principal Investigator Name
* must provide value
Principal Investigator Email Address
* must provide value
This email address is limited to CHCO, UCH, DH, UCD business email only
Principal Investigator Department
Definition: The division, department, or center where the PI has faculty appointment or the UCHealth department in which the PI practices.
* must provide value
CTR-AdvancingProfessionalExcellence CTR-AlzheimersDisease CTR-AnschutzHealth-Wellness CTR-BarbaraDavis CTR-Bioethics-Humanities CTR-CTRIC CTR-ColoradoHealthOutcomes CTR-Depression CTR-Gait-Movement Analysis CTR-Gene-Environment-Health CTR-Hemophilia-Thrombosis CTR-HumanNutrition CTR-HumanSimulation CTR-InstructionalSupport CTR-Intellectual-Developmental-Disabilities CTR- LindaCrnic-DownSyndrome CTR-MarionDownsHearing CTR-NutritionObesityResearch CTR-PerinatalResearch CTR-RockyMtnTaste-Smell CTR- SickleCellTx-Research CTR-SurgicalInnovation CTR-SurgicalTx LungInfection CTR-TraumaResearch CTR-WebbWaring Cancer Center - Other Cancer Clinical Trial Office College-Nursing DHHA-ADMINISTRATION DHHA-ANESTHESIOLOGY DHHA-BEHAVIORAL HEAL DHHA-ACS/CHS DHHA-BUSINESS DEV DHHA-CORRECTIONS DHHA-EMERGENCY MED DHHA-MANAGED CARE DHHA-MEDICINE DHHA-NURSING DHHA-OB/GYN DHHA-OFFICE OF ED DHHA-OFFICE OF RES DHHA-ORTHOPEDICS DHHA-PATIENT SAFETY DHHA-PHYSICAL THERAPY DHHA-SOCIAL WORK DHHA-PEDIATRICS DHHA-PHARMACY DHHA-PUBLIC HEALTH DHHA-RADIOLOGY DHHA-RMPDC DHHA-SURGERY DHHA-EHEALTH SERVICE SOM-Anesthesiology SOM-Biochemistry-MolecularGenetics SOM-Biomedical Informatics SOM-Cell-DevelopmentalBiology SOM-Center for Health Artificial Intelligence SOM-Dermatology SOM-EmergencyMedicine SOM-FamilyMedicine SOM-Immunology SOM-Allergy and Clinical Immunology SOM-Cardiology SOM-Endocrinology, Metabolism and Diabetes SOM-Gastroenterology and Hepatology SOM-General Internal Medicine SOM-Geriatric Medicine SOM-Health Care Policy and Research SOM-Hematology SOM-Hospital Medicine SOM-Infectious Diseases SOM-Medical Oncology SOM-Pulmonary Sciences and Critical Care Medicine SOM-Renal Diseases and Hypertension SOM-Rheumatology SOM-Microbiology SOM-Neurology SOM-Neurosurgery SOM-ObstetricsGynecology SOM-Ophthalmology SOM-Orthopedics SOM-Otolaryngology SOM-Pathology SOM-Pediatrics SOM-Pharmacology SOM-PhysMedicine-Rehab SOM-Physiology-Biophysics SOM-Psychiatry SOM-RadiationOnc SOM-Radiology SOM-Surgery School-DentalMedicine School-Pharmacy School-PublicHealth UCH - metro Denver - Nursing UCH - metro Denver - Pharmacy UCH - Northern Colorado - Cardiology UCH - Northern Colorado - Dermatology UCH - Northern Colorado - Endocrinology UCH - Northern Colorado - External Provider UCH - Northern Colorado - Family Medicine UCH - Northern Colorado - Healthy Hearts UCH - Northern Colorado - Infectious Disease UCH - Northern Colorado - Oncology UCH - Northern Colorado - Orthopaedics UCH - Northern Colorado - Neurosciences UCH - Northern Colorado - Nursing UCH - Northern Colorado - Pain Medicine UCH - Northern Colorado - Pharmacy UCH - Northern Colorado - Pulmonary UCH - Northern Colorado - Trauma UCH - Colorado Springs - Acute Care Rehab UCH - Colorado Springs - Cardiology UCH - Colorado Springs - Emergency Department UCH - Colorado Springs - Forensic Nursing UCH - Colorado Springs - Infectious Disease UCH - Colorado Springs - Neurosciences UCH - Colorado Springs - Nursing UCH - Colorado Springs - Oncology UCH - Colorado Springs - Orthopaedics UCH - Colorado Springs - Pharmacy UCH - Colorado Springs - Plastic Reconstructive Surgery UCH - Colorado Springs - Pulmonary UCH - Colorado Springs - Trauma Other
Find as you type.
Other Department:
* must provide value
Section/Research GroupPlease select the appropriate research group within the department, division, or center that manages the day to day activities of the research study ; this will drive protocol access in OnCore.
* must provide value
Anesthesiology Barbara Davis Center CTR-AltitudeResearch CTR-AmerIndian-AlaskanNativeHlth CTR-CharlesCGates CTR-Kempe-PreventionTx-Child Abuse CTR-Neuroscience CTR-WomensHealth DHHA-ADMIN-ADMINISTRATION DHHA-ADMIN-FINANCE DHHA-ADMIN-GOV RELATIONS DHHA-ADMIN-HUMAN RESOURCES DHHA-ADMIN-PR & MARKETING DHHA-ADMIN-ANESTHESIOLOGY DHHA-ADMIN-ADOLESCENT SUBS DHHA-ADMIN-DENVERCARES DHHA-ADMIN-INPATIENT BEHAV DHHA-ADMIN-OBHS DHHA-ACS/CHS-COMMUNITY VOICES DHHA-ACS/CHS-FAMILY MEDICINE DHHA-ACS/CHS-INTEGRATED BH DHHA-ACS/CHS-INTERNAL MED DHHA-ACS/CHS-PEDIATRICS DHHA-ACS/CHS-SCHOOL & COMM H DHHA-BUS DEV-LGBT COE DHHA-CORR-CORRECTIONS DHHA-EMERG MED-EMERGENCY MED DHHA-EMERG MED-EMS TRAINING DHHA-EMERG MED-PARAMEDICS DHHA-EMERG MED-RMCMR DHHA-MEDICINE-CARDIOLOGY DHHA-MEDICINE-DERMATOLOGY DHHA-MEDICINE-DIA DHHA-MEDICINE-ENDOCRINOLOGY DHHA-MEDICINE-EP NURSING DHHA-MEDICINE-GI DHHA-MEDICINE-HOSPITALIST DHHA-MEDICINE-INFECTIOUS DIS DHHA-MEDICINE-INTERNAL MED DHHA-MEDICINE-MED ADMIN DHHA-MEDICINE-NEPHROLOGY DHHA-MEDICINE-NEUROLOGY DHHA-MEDICINE-OCC HEALTH DHHA-MEDICINE-ONCOLOGY DHHA-MEDICINE-PALLIATIVE CARE DHHA-MEDICINE-PULMONARY DHHA-MEDICINE-RESPIRATORY DHHA-MEDICINE-RHEUMATOLOGY DHHA-NURSING-NURSING DHHA-OB/GYN-OB/GYN DHHA-OFFICE OF ED-ADMINISTRATION DHHA-OFFICE OF RES-ADMINISTRATION DHHA-OFFICE OF RES-HSR DHHA-ORTHO-GENERAL DHHA-ORTHO-PODIATRY DHHA-ORTHO-REHAB MEDICINE DHHA-PATIENT SAFETY-PATIENT SAFETY DHHA-PHYSICAL THERAPY-PHYSICAL THERAPY DHHA-SOCIAL WORK-SOCIAL WORK DHHA-PEDIATRICS-PEDIATRICS DHHA-PHARMACY-PHARMACY DHHA-PUBLIC HEALTH-ADMINISTRATION DHHA-PUBLIC HEALTH-EPIDEM/SURV DHHA-PUBLIC HEALTH-HIV PREVENTION DHHA-PUBLIC HEALTH-ID/AIDS DHHA-PUBLIC HEALTH-IMMUNIZATION DHHA-PUBLIC HEALTH-PREPAREDNESS DHHA-PUBLIC HEALTH-STD DHHA-PUBLIC HEALTH-TB DHHA-PUBLIC HEALTH-VITAL RECORDS DHHA-RADIOLOGY-RADIOLOGY DHHA-RMPDC-DRUG CENTER DHHA-RMPDC-POISON CENTER DHHA-RMPDC-RESEARCH DHHA-SURGERY-OTOLARYNGOLOGY DHHA-SURGERY-GENERAL SURGERY DHHA-SURGERY-NEUROSURGERY DHHA-SURGERY-OPHTHALMOLOGY DHHA-SURGERY-PLASTIC SURGERY DHHA-EHS-EHEALTH SERVICE Emergency Medicine HA-CTRC Med-Allergy-ClinImmunol Med-Cardiology Med-ClinPharm-Toxicol Med-Dermatology Med-EndocrineMetabDiabetes Med-EndocrineMetabDiabetes-CUDECT Med-Gastroenterology Med-GenInternalMed Med-Geriatrics Med-HealthCarePolicy-Res Med-Hematology Med-InfectDisease Med-PulmonSci-CritCare Med-RenalMed-Hypertension Med-Rheumatology Neuro-BehavNeurology Neuro-Epilepsy Neuro-GenNeurology Neuro-MovementDisorders Neuro-NeuroOphthalmology Neuro-Neurohospital-Vascular Neuro-Neuroimmuno-MS Neuro-Neuromuscular Neurosurgery OBGYN-Family Planning OBGYN-General Obstetrics and Gynecology OBGYN-Maternal Fetal Medicine OBGYN-OB Other (TBD) OBGYN-Reproductive Endocrinology OBGYN-Reproductive Sciences OBGYN-Urogynecology and Reconstructive Pelvic Surgery Oncology Ophthalmology Ortho-Basic Science Ortho-Denver Health Ortho-Foot and Ankle Ortho-Hand Ortho-Hip and Joint Ortho-Pediatrics Ortho-Shoulder and Elbow Ortho-Spine Ortho-Sports Medicine Ortho-Trauma Oto-Aerodigestive Oto-Airway Oto-Audiology/Otology Oto-Facial Plastics Oto-General ENT Oto-Head and Neck Oncology Oto-Laryngology Oto-Pediatrics Oto-Practice Patterns Oto-Residency Oto-Rhinology Oto-Sleep Peds-AdolescentMed Peds-Allergy & Immunology Peds-Cardiology Peds-CCBD Peds-ChildAbuse & Neglect (Kempe Center) Peds-CriticalCare Peds-Developmental Pediatrics Peds-Developmental Biology Peds-Epidemiology Peds-Emergency Peds-Endocrinology Peds-GastroHepatolNutrition Peds-GenAcademicPeds Peds-Genetics-Metabolism Peds-Hemotology Peds-Hospitalist Medicine Peds-InfectiousDisease Peds-Neonatology Peds-Nephrology Peds-Neurology Peds-Nutrition Peds-Prevention Research Center Peds-Pulmonary Peds-Rheumatology PhysMedicine-Rehab Psych-ChildAdolscentPsychiatry Psych- Developmental Psychiatry Research Group Psych-Psychology Rad-AbdomImaging Rad-BreastImaging Rad-Interventional Rad-Musculoskeletal Rad-Neuroradiology Rad-NuclearMedicine Rad-RadiologicalSci Rad-ThoracicImaging SDM-Orthodontics SDM-Periodontics SOP-ClinicalPharmacy SOP-PharmaceuticalSciences SPH-Biostat-Informatics SPH-Community-BehavioralHealth SPH-Environ-OccupHealth SPH-Epidemiology SPH-HealthMgmt-Policy Surg-BurnSurg Surg-CardiothoracicSurg Surg-GITumor-EndocrineSurg Surg-PedsSurg Surg-Plastic-ReconstrSurg Surg-Podiatry Surg-Transplant Surg-Urology Surg-VascularSurg UCH - Denver Metro - Nursing UCH - Denver Metro - Pharmacy UCH - NC - Cardiology UCH-NC-Family Medicine UCH - NC - Trauma UCH - NC - Oncology UCH - NC - Orthopaedics UCH - NC - Infectious Disease UCH - NC - Dermatology UCH - NC - Pharmacy UCH - NC - Neurosciences UCH - NC - Nursing UCH - NC - Pulmonary UCH - NC - Healthy Hearts UCH - CS - Cardiology UCH - CS - Trauma UCH - CS - Oncology UCH - CS - Orthopaedics UCH - CS - Infectious Disease UCH - CS - Pharmacy UCH - CS - Pulmonary UCH - CS - Neurosciences UCH - CS - Nursing Other
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Other Section/Research Group:
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Are you requesting use of the "On Study (Urgent)" workflow in Epic?
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Yes
No
Use of the "On Study (Urgent)" workflow requires approval the the Children's Research Review Committee (CR2C).
Is the PI also the Recruitment Contact for this study?
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Yes
No
Is the PI also the contact for regulatory questions?
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Yes
No
Is the PI also the person for finance/budget questions?
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Yes
No
Will the PI be responsible for receiving hospital invoices?
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Yes
No
Primary Contact Email Address
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This email address is limited to CHCO, UCH, DH, UCD business email only
Is this also the person for regulatory questions?
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Yes
No
Is this also the person for finance/budget questions?
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Yes
No
Will the contact for subject recruitment receive hospital invoices?
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Yes
No
Regulatory Coordinator Name
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Regulatory Coordinator Email Address
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This email address is limited to CHCO, UCH, DH, UCD business email only
This email address is limited to CHCO, UCH, DH, UCD business email only
Will the finance contact receive hospital invoices?
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Yes
No
Email
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This email address is limited to CHCO, UCH, DH, UCD business email only
Please provide the email address for the individual or group that will receive hospital invoices.
Please note: only one individual may be listed in this role in OnCore. If multiple individuals must receive the invoice, then please work with your IT team to create a shared email.
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This email address is limited to CHCO, UCH, DH, UCD business email only
RI Research Project Manager (RPM)
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Email:
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This email address is limited to CHCO business email only
Site (Regional) Principal Investigators
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List the PI for each UCHealth region.
List all Co-Investigators on this project
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Select protocol type:
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Basic Science - A research study aimed at understanding the development, structure and function of physiological systems.
Device Feasibility - Protocol designed to evaluate one or more interventions for the feasibility of the product or to test a prototype device and not health outcomes.
Diagnostic - A research study that evaluates methods of detecting disease.
Health Services Research - A research study aimed at assessing the cost, access to, and quality of health care services.
Observational - A type of study in which individuals are observed or certain outcomes are measured. No attempt is made to affect the outcome (for example, no treatment is given).
Other
Outcomes Research - A research study aimed at measuring a specific result or effect. Examples of outcomes include decreased pain, reduced tumor size and improvement of disease.
Prevention - A type of research study involving healthy people that looks at disease risk and ways to reduce that risk. In most prevention trials, the participants either do not have a disease but are at high risk for developing it.
Registry - A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition.
Retrospective - A research study that evaluates patient data that is existing at the time the protocol is submitted to the IRB for initial approval.
Screening - A type of trial that tests new ways to find disease early. An effective screening test will reduce the number of deaths from the disease being screened.
Supportive Care - A type of trial that aims to improve the quality of life of patients. These studies find new ways to help people cope with pain, nutrition problems, infection, nausea and vomiting, sleep disorders, depression, and other health problems. Trials might test drugs or test activities, such as attending support groups, exercising, or talking with a counselor.
Treatment - A type of trial that tests new treatments or new ways of using existing treatments, such as new drugs, vaccines, approaches to surgery or radiation therapy, and combinations of treatments.
Select protocol type:
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Treatment: Evaluate one or more interventions for treating a disease, syndrome or condition.
Supportive Care: Evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects, or mitigate against a decline in the participant's health or function. Not intended to cure a disease.
Diagnostic: Evaluate one or more interventions aimed at identifying a disease or health condition.
Screening: Assess or examine methods of identifying a condition (or risk factor for a condition) in people who are not yet known to have the condition (or risk factor).
Prevention: Assess one or more interventions aimed at preventing the development of a specific disease or health condition.
Basic Science: Examine the basic mechanisms of action (e.g., physiology, biomechanics) or an intervention.
Health Services Research: Evaluate the delivery, process, management, organization, or financing of health care.
Device Feasibility - Protocol designed to evaluate one or more interventions for the feasibility of the product or to test a prototype device and not health outcomes.
Registry - A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition.
Other: Not in other categories.
Select one.
Disease being studied (organized by Diagnosis Code)
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A15: Respiratory tuberculosis A17: Tuberculosis of nervous system A18: Tuberculosis of other organs A19: Miliary tuberculosis A22: Anthrax A48: Other bacterial diseases, not elsewhere classified A69: Other spirochetal infections A79: Other rickettsioses A81: Atypical virus infections of central nervous system A88: Oth viral infections of central nervous system, NEC A98: Other viral hemorrhagic fevers, not elsewhere classified B00: Herpesviral [herpes simplex] infections B08: Oth viral infect with skin and mucous membrane lesions, NEC B10: Other human herpesviruses B19: Unspecified viral hepatitis B33: Other viral diseases, not elsewhere classified B34: Viral infection of unspecified site B48: Other mycoses, not elsewhere classified B66: Other fluke infections B71: Other cestode infections B83: Other helminthiases B88: Other infestations B99: Other and unspecified infectious diseases C00: Malignant neoplasm of lip C01: Malignant neoplasm of base of tongue C02: Malignant neoplasm of other and unspecified parts of tongue C03: Malignant neoplasm of gum C04: Malignant neoplasm of floor of mouth C05: Malignant neoplasm of palate C06: Malignant neoplasm of other and unspecified parts of mouth C07: Malignant neoplasm of parotid gland C08: Malignant neoplasm of other and unsp major salivary glands C09: Malignant neoplasm of tonsil C10: Malignant neoplasm of oropharynx C11: Malignant neoplasm of nasopharynx C12: Malignant neoplasm of pyriform sinus C13: Malignant neoplasm of hypopharynx C14: Malig neoplasm of sites in the lip, oral cavity and pharynx C15: Malignant neoplasm of esophagus C16: Malignant neoplasm of stomach C17: Malignant neoplasm of small intestine C18: Malignant neoplasm of colon C19: Malignant neoplasm of rectosigmoid junction C20: Malignant neoplasm of rectum C21: Malignant neoplasm of anus and anal canal C22: Malignant neoplasm of liver and intrahepatic bile ducts C23: Malignant neoplasm of gallbladder C24: Malignant neoplasm of other and unsp parts of biliary tract C25: Malignant neoplasm of pancreas C26: Malignant neoplasm of other and ill-defined digestive organs C30: Malignant neoplasm of nasal cavity and middle ear C31: Malignant neoplasm of accessory sinuses C32: Malignant neoplasm of larynx C33: Malignant neoplasm of trachea C34: Malignant neoplasm of bronchus and lung C37: Malignant neoplasm of thymus C38: Malignant neoplasm of heart, mediastinum and pleura C39: Malig neoplm of sites in the resp sys and intrathorac organs C40: Malignant neoplasm of bone and articular cartilage of limbs C41: Malignant neoplasm of bone/artic cartl of and unsp sites C43: Malignant melanoma of skin C4A: Merkel cell carcinoma C44: Other and unspecified malignant neoplasm of skin C45: Mesothelioma C46: Kaposi's sarcoma C47: Malignant neoplasm of prph nerves and autonomic nervous sys C48: Malignant neoplasm of retroperitoneum and peritoneum C49: Malignant neoplasm of other connective and soft tissue C50: Malignant neoplasm of breast C51: Malignant neoplasm of vulva C52: Malignant neoplasm of vagina C53: Malignant neoplasm of cervix uteri C54: Malignant neoplasm of corpus uteri C55: Malignant neoplasm of uterus, part unspecified C56: Malignant neoplasm of ovary C57: Malignant neoplasm of other and unsp female genital organs C58: Malignant neoplasm of placenta C60: Malignant neoplasm of penis C61: Malignant neoplasm of prostate C62: Malignant neoplasm of testis C63: Malignant neoplasm of other and unsp male genital organs C64: Malignant neoplasm of kidney, except renal pelvis C65: Malignant neoplasm of renal pelvis C66: Malignant neoplasm of ureter C67: Malignant neoplasm of bladder C68: Malignant neoplasm of other and unspecified urinary organs C69: Malignant neoplasm of eye and adnexa C70: Malignant neoplasm of meninges C71: Malignant neoplasm of brain C72: Malig neoplm of spinal cord, cranial nerves and oth prt cnsl C73: Malignant neoplasm of thyroid gland C74: Malignant neoplasm of adrenal gland C75: Malignant neoplasm of endo glands and related structures C7A: Malignant neuroendocrine tumors C7B: Secondary neuroendocrine tumors C76: Malignant neoplasm of other and ill-defined sites C77: Secondary and unspecified malignant neoplasm of lymph nodes C78: Secondary malignant neoplasm of resp and digestive organs C79: Secondary malignant neoplasm of other and unspecified sites C80: Malignant neoplasm without specification of site C81: Hodgkin lymphoma C82: Follicular lymphoma C83: Non-follicular lymphoma C84: Mature T/NK-cell lymphomas C85: Oth and unspecified types of non-Hodgkin lymphoma C86: Other specified types of T/NK-cell lymphoma C88: Malig immunoproliferative dis and certain oth B-cell lymph C90: Multiple myeloma and malignant plasma cell neoplasms C91: Lymphoid leukemia C92: Myeloid leukemia C93: Monocytic leukemia C94: Other leukemias of specified cell type C95: Leukemia of unspecified cell type C96: Oth & unsp malig neoplm of lymphoid, hematpoetc and rel tiss D45: Polycythemia vera D46: Myelodysplastic syndromes D47: Oth neoplm of uncrt behav of lymphoid, hematpoetc & rel tiss D49: Neoplasms of unspecified behavior D55: Anemia due to enzyme disorders D56: Thalassemia D57: Sickle-cell disorders D58: Other hereditary hemolytic anemias D59: Acquired hemolytic anemia D61: Oth aplastic anemias and other bone marrow failure syndromes D68: Other coagulation defects D69: Purpura and other hemorrhagic conditions D72: Other disorders of white blood cells D73: Diseases of spleen D75: Other and unsp diseases of blood and blood-forming organs D76: Oth dis with lymphoreticular and reticulohistiocytic tissue D80: Immunodeficiency with predominantly antibody defects D81: Combined immunodeficiencies D83: Common variable immunodeficiency D84: Other immunodeficiencies D86: Sarcoidosis D89: Oth disorders involving the immune mechanism, NEC E01: Iodine-deficiency related thyroid disorders and allied cond E03: Other hypothyroidism E05: Thyrotoxicosis [hyperthyroidism] E06: Thyroiditis E07: Other disorders of thyroid E10: Type 1 diabetes mellitus E11: Type 2 diabetes mellitus E13: Other specified diabetes mellitus E16: Other disorders of pancreatic internal secretion E20: Hypoparathyroidism E21: Hyperparathyroidism and other disorders of parathyroid gland E22: Hyperfunction of pituitary gland E23: Hypofunction and other disorders of the pituitary gland E27: Other disorders of adrenal gland E28: Ovarian dysfunction E29: Testicular dysfunction E32: Diseases of thymus E34: Other endocrine disorders E66: Overweight and obesity E72: Other disorders of amino-acid metabolism E74: Other disorders of carbohydrate metabolism E75: Disord of sphingolipid metab and oth lipid storage disorders E76: Disorders of glycosaminoglycan metabolism E77: Disorders of glycoprotein metabolism E78: Disorders of lipoprotein metabolism and other lipidemias E79: Disorders of purine and pyrimidine metabolism E80: Disorders of porphyrin and bilirubin metabolism E83: Disorders of mineral metabolism E84: Cystic fibrosis E85: Amyloidosis E87: Other disorders of fluid, electrolyte and acid-base balance E88: Other and unspecified metabolic disorders F01: Vascular dementia F03: Unspecified dementia F10: Alcohol related disorders F11: Opioid related disorders F12: Cannabis related disorders F13: Sedative, hypnotic, or anxiolytic related disorders F14: Cocaine related disorders F15: Other stimulant related disorders F16: Hallucinogen related disorders F17: Nicotine dependence F18: Inhalant related disorders F19: Other psychoactive substance related disorders F20: Schizophrenia F25: Schizoaffective disorders F30: Manic episode F31: Bipolar disorder F32: Major depressive disorder, single episode F33: Major depressive disorder, recurrent F34: Persistent mood [affective] disorders F40: Phobic anxiety disorders F41: Other anxiety disorders F43: Reaction to severe stress, and adjustment disorders F44: Dissociative and conversion disorders F45: Somatoform disorders F48: Other nonpsychotic mental disorders F50: Eating disorders F51: Sleep disorders not due to a substance or known physiol cond F52: Sexual dysfnct not due to a substance or known physiol cond F55: Abuse of non-psychoactive substances F60: Specific personality disorders F63: Impulse disorders F64: Gender identity disorders F65: Paraphilias F68: Other disorders of adult personality and behavior F80: Specific developmental disorders of speech and language F81: Specific developmental disorders of scholastic skills F84: Pervasive developmental disorders F90: Attention-deficit hyperactivity disorders F91: Conduct disorders F93: Emotional disorders with onset specific to childhood F94: Disord social w onset specific to childhood and adolescence F98: Oth behav/emotn disord w onset usly occur in chldhd and adol G00: Bacterial meningitis, not elsewhere classified G03: Meningitis due to other and unspecified causes G04: Encephalitis, myelitis and encephalomyelitis G06: Intracranial and intraspinal abscess and granuloma G11: Hereditary ataxia G12: Spinal muscular atrophy and related syndromes G23: Other degenerative diseases of basal ganglia G24: Dystonia G25: Other extrapyramidal and movement disorders G30: Alzheimer's disease G31: Oth degenerative diseases of nervous system, NEC G37: Other demyelinating diseases of central nervous system G40: Epilepsy and recurrent seizures G43: Migraine G44: Other headache syndromes G45: Transient cerebral ischemic attacks and related syndromes G46: Vascular syndromes of brain in cerebrovascular diseases G47: Sleep disorders G50: Disorders of trigeminal nerve G51: Facial nerve disorders G52: Disorders of other cranial nerves G54: Nerve root and plexus disorders G56: Mononeuropathies of upper limb G57: Mononeuropathies of lower limb G58: Other mononeuropathies G60: Hereditary and idiopathic neuropathy G61: Inflammatory polyneuropathy G62: Other and unspecified polyneuropathies G70: Myasthenia gravis and other myoneural disorders G71: Primary disorders of muscles G72: Other and unspecified myopathies G80: Cerebral palsy G81: Hemiplegia and hemiparesis G82: Paraplegia (paraparesis) and quadriplegia (quadriparesis) G83: Other paralytic syndromes G90: Disorders of autonomic nervous system G91: Hydrocephalus G93: Other disorders of brain G95: Other and unspecified diseases of spinal cord G98: Other disorders of nervous system not elsewhere classified H04: Disorders of lacrimal system H05: Disorders of orbit H15: Disorders of sclera H18: Other disorders of cornea H21: Other disorders of iris and ciliary body H25: Age-related cataract H26: Other cataract H27: Other disorders of lens H31: Other disorders of choroid H33: Retinal detachments and breaks H34: Retinal vascular occlusions H35: Other retinal disorders H40: Glaucoma H43: Disorders of vitreous body H44: Disorders of globe H46: Optic neuritis H47: Other disorders of optic [2nd] nerve and visual pathways H50: Other strabismus H51: Other disorders of binocular movement H52: Disorders of refraction and accommodation H55: Nystagmus and other irregular eye movements H57: Other disorders of eye and adnexa H61: Other disorders of external ear H69: Other and unspecified disorders of Eustachian tube H71: Cholesteatoma of middle ear H73: Other disorders of tympanic membrane H74: Other disorders of middle ear mastoid H80: Otosclerosis H81: Disorders of vestibular function H83: Other diseases of inner ear H90: Conductive and sensorineural hearing loss H93: Other disorders of ear, not elsewhere classified I01: Rheumatic fever with heart involvement I11: Hypertensive heart disease I12: Hypertensive chronic kidney disease I21: STEMI & NSTEMI mocard infrc I24: Other acute ischemic heart diseases I25: Chronic ischemic heart disease I26: Pulmonary embolism I27: Other pulmonary heart diseases I28: Other diseases of pulmonary vessels I31: Other diseases of pericardium I34: Nonrheumatic mitral valve disorders I35: Nonrheumatic aortic valve disorders I36: Nonrheumatic tricuspid valve disorders I37: Nonrheumatic pulmonary valve disorders I42: Cardiomyopathy I45: Other conduction disorders I49: Other cardiac arrhythmias I67: Other cerebrovascular diseases I70: Atherosclerosis I71: Aortic aneurysm and dissection I72: Other aneurysm I73: Other peripheral vascular diseases I74: Arterial embolism and thrombosis I75: Atheroembolism I77: Other disorders of arteries and arterioles I78: Diseases of capillaries I80: Phlebitis and thrombophlebitis I82: Other venous embolism and thrombosis I83: Varicose veins of lower extremities I85: Esophageal varices I86: Varicose veins of other sites I87: Other disorders of veins I89: Oth noninfective disorders of lymphatic vessels and nodes I95: Hypotension I99: Other and unspecified disorders of circulatory system J34: Other and unspecified disorders of nose and nasal sinuses J38: Diseases of vocal cords and larynx, not elsewhere classified J39: Other diseases of upper respiratory tract J43: Emphysema J44: Other chronic obstructive pulmonary disease J45: Asthma J70: Respiratory conditions due to other external agents J84: Other interstitial pulmonary diseases J94: Other pleural conditions J98: Other respiratory disorders K00: Disorders of tooth development and eruption K03: Other diseases of hard tissues of teeth K04: Diseases of pulp and periapical tissues K05: Gingivitis and periodontal diseases K06: Other disorders of gingiva and edentulous alveolar ridge K08: Other disorders of teeth and supporting structures K11: Diseases of salivary glands K13: Other diseases of lip and oral mucosa K14: Diseases of tongue K20: Esophagitis K21: Gastro-esophageal reflux disease K22: Other diseases of esophagus K31: Other diseases of stomach and duodenum K38: Other diseases of appendix K50: Crohn's disease [regional enteritis] K55: Vascular disorders of intestine K57: Diverticular disease of intestine K58: Irritable bowel syndrome K59: Other functional intestinal disorders K62: Other diseases of anus and rectum K63: Other diseases of intestine K66: Other disorders of peritoneum K68: Disorders of retroperitoneum K73: Chronic hepatitis, not elsewhere classified K74: Fibrosis and cirrhosis of liver K75: Other inflammatory liver diseases K76: Other diseases of liver K82: Other diseases of gallbladder K83: Other diseases of biliary tract K86: Other diseases of pancreas K90: Intestinal malabsorption K92: Other diseases of digestive system L11: Other acantholytic disorders L13: Other bullous disorders L40: Psoriasis L44: Other papulosquamous disorders L51: Erythema multiforme L53: Other erythematous conditions L58: Radiodermatitis L59: Oth disorders of skin, subcu related to radiation L81: Other disorders of pigmentation L90: Atrophic disorders of skin L91: Hypertrophic disorders of skin L92: Granulomatous disorders of skin and subcutaneous tissue L93: Lupus erythematosus L94: Other localized connective tissue disorders L95: Vasculitis limited to skin, not elsewhere classified L98: Oth disorders of skin, subcu, not elsewhere classified M00: Pyogenic arthritis M05: Rheumatoid arthritis with rheumatoid factor M06: Other rheumatoid arthritis M07: Enteropathic arthropathies M08: Juvenile arthritis M10: Gout M11: Other crystal arthropathies M13: Other arthritis M15: Polyosteoarthritis M16: Osteoarthritis of hip M17: Osteoarthritis of knee M18: Osteoarthritis of first carpometacarpal joint M19: Other and unspecified osteoarthritis M25: Other joint disorder, not elsewhere classified M27: Other diseases of jaws M30: Polyarteritis nodosa and related conditions M31: Other necrotizing vasculopathies M32: Systemic lupus erythematosus (SLE) M33: Dermatopolymyositis M34: Systemic sclerosis [scleroderma] M35: Other systemic involvement of connective tissue M40: Kyphosis and lordosis M41: Scoliosis M42: Spinal osteochondrosis M43: Other deforming dorsopathies M45: Ankylosing spondylitis M46: Other inflammatory spondylopathies M47: Spondylosis M48: Other spondylopathies M50: Cervical disc disorders M51: Thoracic, thoracolum, and lumbosacral intvrt disc disorders M53: Other and unspecified dorsopathies, not elsewhere classified M62: Other disorders of muscle M67: Other disorders of synovium and tendon M76: Enthesopathies, lower limb, excluding foot M77: Other enthesopathies M79: Oth and unsp soft tissue disorders, not elsewhere classified M81: Osteoporosis without current pathological fracture M84: Disorder of continuity of bone M85: Other disorders of bone density and structure M88: Osteitis deformans [Paget's disease of bone] M89: Other disorders of bone M91: Juvenile osteochondrosis of hip and pelvis M92: Other juvenile osteochondrosis M93: Other osteochondropathies M94: Other disorders of cartilage M95: Oth acquired deformities of ms sys and connective tissue M99: Biomechanical lesions, not elsewhere classified N04: Nephrotic syndrome N07: Hereditary nephropathy, not elsewhere classified N11: Chronic tubulo-interstitial nephritis N18: Chronic kidney disease (CKD) N28: Oth disorders of kidney and ureter, not elsewhere classified N31: Neuromuscular dysfunction of bladder, NEC N32: Other disorders of bladder N36: Other disorders of urethra N39: Other disorders of urinary system N41: Inflammatory diseases of prostate N42: Other and unspecified disorders of prostate N44: Noninflammatory disorders of testis N46: Male infertility N47: Disorders of prepuce N48: Other disorders of penis N49: Inflammatory disorders of male genital organs, NEC N50: Other and unspecified disorders of male genital organs N52: Male erectile dysfunction N53: Other male sexual dysfunction N64: Other disorders of breast N71: Inflammatory disease of uterus, except cervix N76: Other inflammation of vagina and vulva N80: Endometriosis N97: Female infertility N98: Complications associated with artificial fertilization O15: Eclampsia O43: Placental disorders P05: Disord of NB related to slow fetal growth and fetal malnut P07: Disord of NB related to short gest and low birth weight, NEC P08: Disord of newborn related to long gest and high birth weight P28: Oth respiratory conditions origin in the perinatal period P29: Cardiovascular disorders originating in the perinatal period P55: Hemolytic disease of newborn P57: Kernicterus P59: Neonatal jaundice from other and unspecified causes P61: Other perinatal hematological disorders P78: Other perinatal digestive system disorders P83: Other conditions of integument specific to newborn P91: Other disturbances of cerebral status of newborn Q04: Other congenital malformations of brain Q05: Spina bifida Q06: Other congenital malformations of spinal cord Q07: Other congenital malformations of nervous system Q15: Other congenital malformations of eye Q17: Other congenital malformations of ear Q18: Other congenital malformations of face and neck Q24: Other congenital malformations of heart Q25: Congenital malformations of great arteries Q26: Congenital malformations of great veins Q28: Other congenital malformations of circulatory system Q34: Other congenital malformations of respiratory system Q38: Other congenital malformations of tongue, mouth and pharynx Q39: Congenital malformations of esophagus Q45: Other congenital malformations of digestive system Q64: Other congenital malformations of urinary system Q68: Other congenital musculoskeletal deformities Q82: Other congenital malformations of skin Q83: Congenital malformations of breast Q84: Other congenital malformations of integument Q89: Other congenital malformations, not elsewhere classified Q90: Down syndrome Q91: Trisomy 18 and Trisomy 13 Q92: Oth trisomies and partial trisomies of the autosomes, NEC Q93: Monosomies and deletions from the autosomes, NEC Q95: Balanced rearrangements and structural markers, NEC Q96: Turner's syndrome B20:Human immunodeficiency virus [HIV] disease Other, Not Listed (please list in box below) Z34: Normal Pregnancy G20: Parkinson's disease Z006: Healthy Subjects No disease or diagnosis being studied U07.1 COVID-19, virus identified
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Enter other (not listed above) or any additional Disease or Diagnosis Codes being studied.
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Industry Initiated, Investigator Initiated, or Cooperative Group Protocol?(If the protocol has industry funding but was written by the investigator, then the protocol is NOT industry initiated.)
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Industry Initiated Investigator Initiated Cooperative Group
Investigator Initiated includes protocols that are NIH Consortiums or NIH funded to an external site
Please provide the name of the Cooperative Group:
* must provide value
Investigator Initiated
* must provide value
Locally written
Originally initiated at external institution
Has the protocol or grant been peer-reviewed by an independent body (such as NIH study section or the FDA)?
* must provide value
Yes
No
Is this a multisite protocol?
* must provide value
Yes
No
Is this study part of a consortium or similar group?
* must provide value
Yes
No
Please select the name of the the consortium or cooperative group. If there is none, please select 'none'.
* must provide value
BMT-CTN CaNVAS CIBMTR COG CPCCRN CONNECT CARRAnet GAIN ICON NANT NAPAAC National Marrow Donor Program (NMDP) NEXT NPCF N3C PECARN PIDTC PTCTC Pediatric Brain Tumor Consortium Peds CITN PEDSnet PCORnet TACL Other COG PHI COG Campfire
Please enter other consortium name:
* must provide value
What is the name of the coordinating center and/or operations center (institution, drug company, cooperative group)? i.e., Who has control of the study?
* must provide value
Is the UCD PI faculty responsible for oversight of any external study sites?
* must provide value
Yes
No
COMIRB WIRB/WCG NCI CIRB Advarra IRB Other External IRB
Is your study limited to the following area(s)?
* must provide value
Yes
No
Is this study minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).
* must provide value
Yes
No
Funding Type
* must provide value
Is there a contract, work order, or other written agreement associated with this protocol?
* must provide value
Yes
No
Does this written agreement involve industry support?
* must provide value
Yes
No
Please upload your protocol
* must provide value
This appears to fit the criteria for Exempt review. If you do not agree, please select 'No', otherwise, select 'yes'.
If selecting 'yes' please upload your protocol in the field above this question before ending the survey .
Once you select 'yes', your answers will be recorded. You do not need to complete any questions further down on this form. However, if you missed any questions before this point, please complete them before selecting an answer for this question. Failure to complete questions in the survey will delay processing of your protocol.
If you need lab services, you will need to complete the ancillary form after completion of this survey. After you select 'Yes', you will be asked if you would like to end the survey. Confirm this answer. The page this takes you to will have the CHCO ancillary services form. Please complete if you will need lab services.
* must provide value
Yes
No
If externally funded, please provide a backup account to facilitate a G0 for your project. The backup account will not be charged unless the contract is never executed. If unfunded, indicate N/A.
* must provide value
Will this study need to pay for CHCO Services e.g. (personnel, hospital services billable through Epic, Greenphire, subject stipends) with funds originating at the University?
* must provide value
Yes
No
If University funds that need to flow to CHCO to pay for services, please ensure that you finance/budget specialist initiates this process to avoid delays in study activation.
Has this protocol been submitted to and accepted by the industry funder?
* must provide value
Yes
No
Where did the idea for the study originate?
* must provide value
Protocol was initiated by the local investigator Protocol was initiated by external collaborating investigator Industry asked investigator to develop the protocol Industry developed the protocol
Who wrote the protocol?
* must provide value
Local investigator or team of investigators Industry representative
Where will the study database reside?
* must provide value
Industry Academic institution
If funded by NIH, is this a career (K series) award
* must provide value
Yes No N/A
If the project is being funded by an NIH award, please specify the type of award (e.g. R01, P01, T, K, F, etc.). If not applicable, please enter N/A.
* must provide value
Yes
No
Pilot Feasibility Phase I Phase I/II Phase II Phase II/III Phase III Phase III/IV Phase IV Other Study Type
1
2
3
4
5
6+
This study does not have arms
Will you be participating in ALL of the study arms?
* must provide value
Yes
No
Explain in detail which arms are active at our site(s).
* must provide value
Please upload written confirmation from sponsor as to any limitation on which arms will be active
This study involves clinical interactions and thus a calendar build in OnCore is required.
Once the calendar is built, a notification will be sent to your team to review the calendar and then proceed with signoffs once the financials are entered.
Will the Primary Contact listed above also conduct the calendar review in OnCore?
Yes
No
Enter the email address of the person that will complete the Initial Calendar Review
* must provide value
The Finance/Budget contact listed above will conduct the Pre-Award Signoff unless you revise protocol staff roles in OnCore.
Enter the email address of the individual that will complete the Research Manager Signoff of the calendar.
* must provide value
This person verifies that both calendar and financials are correct.
In order to build this protocol in OnCore, the visit structure and procedures must be clearly defined in the protocol. If this is unclear, it will cause delays in the build process. A calendar of events in table format can be helpful. Please see below for a template to include with this submission if one does not already exist.
Calendar of Events Template
In order to build this protocol in OnCore, the visit structure and procedures must be clearly defined in the protocol. If this is unclear, it will cause delays in the build process. A calendar of events in table format can be helpful. Please see below for a template to include with this submission if one does not already exist.
What would you like the study arms to be named? Please include both a code (max 10 characters) and description.For example:
* must provide value
These will be used to identify the arms in OnCore and will appear on data and calendar reports.
Are all procedures and visits captured on the schedule of events?
* must provide value
Yes
No
Please explain which procedures and visits are not captured on the schedule of events and upload any additional documentation that will assist with the OnCore calendar build to this portal submission.
* must provide value
Is the timing between visits explained in detail, including the time unit and ranges?
* must provide value
Yes
No
Detail is required to properly place each visit in relation to other visits on the calendar.
Please explain in detail the timing between the visits?
* must provide value
Will any visits be performed by another research team/sponsor/etc.?
* must provide value
Yes
No
Please explain.
* must provide value
Does this study have a waiver of documentation of consent?
* must provide value
Yes
No
Detail is required to properly place each visit in relation to other visits on the calendar.
Does this study have a waiver of consent?
* must provide value
Yes
No
Which procedures occur before consent is documented?
* must provide value
The OnCore Support Team will build the calendar for this protocol but will not enter financial information until a fully executed contract and budget are received at: OnCoreSupport@UCDenver.edu .
Does the study team intend to use OnCore to generate invoices?
* must provide value
Yes
No
You have selected that this study will not use OnCore to invoice.
What does this mean for you?
The Project Analyst will build the calendar and once the initial calendar is approved, it will be sent to QA signoff when study team staff training is complete. The negotiated milestone and/or pass thru amounts will not be entered in OnCore.
Please note: Institutional QA signoff requirements will still apply.
* must provide value
You have selected that this study will use OnCore to invoice.
What does this mean for you?
The Project Analyst (PA) will build the calendar and once the initial calendar is approved, the PA will wait for you or your team to send the finalized financial documents. The negotiated milestone and/or pass thru amounts will be entered in OnCore.
The FE CTA or grant/award is required for financial entry. Please note that budget items must be clear, so often an internal budget - or clean not scanned version of the budget attachment from the CTA - is necessary to complete financial entry
* must provide value
How should financials appear on an invoice (in the case of industry sponsors) or on an expense report (for other sponsor types)?
* must provide value
Check all that apply.
This is the UCDenver or UChealth address where payments will be sent
Because this study is being conducted at multiple UCHealth regions will one region need to contract with another?
* must provide value
Yes
No
Because this study is being conducted at multiple UCHealth regions will one region need to invoice another?
* must provide value
Yes
No
Who are the satellite sites?
* must provide value
What are the ages of the subjects?
* must provide value
Check all that apply
Which subject populations will you recruit?
* must provide value
Check all that apply
In order to facilitate research with pregnant women and their infants at the Anschutz Medical Campus (AMC), and to be fair to all perinatal investigators involved in perinatal research, it is required that ALL potential perinatal research protocols be reviewed by the Perinatal Research Advisory and Facilitation Committee (PRAFC). The PRAFC is committed to fostering coordinated, multi-disciplinary, collaborative perinatal research. https://cctsi.cuanschutz.edu/resources/elep
Estimated Accrual Duration
Please enter in months
* must provide value
Enter the number of months the protocol will be accepting accruals.
Local Protocol Enrollment (number of participants expected to be on study)
Note: This is used for monitoring accrual rates and is the "RC Total Accrual Goal (Lower)" (ie. Lower Accrual Goal) entered in OnCore.
* must provide value
Enter the expected number of subjects to accrue (on study) locally.
Anticipated Number of Consented Subjects
Note: This is used for monitoring accrual rates and is the "RC Total Accrual Goal (Upper)" (i.e. Upper Accrual goal) entered in OnCore.
* must provide value
Enter the upper goal of consented subjects. This number will match the number in your informed consent.
Total Protocol Enrollment
Note: This is the "Protocol Target Accrual" entered in OnCore.
* must provide value
If multicenter national study, enter the accrual number for the entire study. If investigator-initiated trial (IIT), enter the accrual number for the IIT.
Total Anticipated Duration of Study
Please enter in months
* must provide value
Enter the expected number of months to study completion--when the final subject is examined or receives an intervention for the purposes of final collection of data for the primary outcome. This number is often found in the statistical section of your protocol.
Are you requesting support from UCD Pathology Shared Resource?
* must provide value
Yes
No
Which services are required by the protocol?
* must provide value
Will this study involve the investigation of a drug or biologic?
* must provide value
Yes
No
Which pharmacy will manage the investigational drug(s)?
Please select "other" if the drug will be stored in the Clinical Translational Research Center storage room(s).
* must provide value
UCHealth UCHealth Investigational Pharmacy UCHealth Nuclear Medicine VA CHCO CU Anschutz Research Pharmacy Other
Which "other" pharmacy will manage the investigational drug or describe the method of delivery of the investigational drug to the participant.
* must provide value
Is the study team managing ALL of the following for the delivery mechanism (e.g. device such as Continuous Glucose Monitor, safety syringe for self-administration) for the investigational drug?
* must provide value
Yes
No
Is the study team managing ALL of the following for the delivery mechanism (e.g. device such as Continuous Glucose Monitor, safety syringe for self-administration) for the investigational drug?
* must provide value
Yes
No
N/A - no delivery mechanism supply for investigational drug
How many drugs will be given as part of the study?
* must provide value
Include standard of care and research
Route of administration
* must provide value
Oral IV Both Oral and IV Intrathecal/Lumbar Puncture (LP) Other
For Intrathecal/LP delivery: What is the expected frequency of dosing?
* must provide value
For Intrathecal/LP delivery: what is the expected number of procedures?
* must provide value
Does the protocol or pharmacy manual specify equipment or supplies needed for administration?
* must provide value
Yes
No
Does the protocol require a period of observation following drug administration?
* must provide value
Yes
No
What is the longest period of observation required?
* must provide value
Will this study involve the use of antisense oligonucleotides (ASOs)?
* must provide value
Yes
No
The following questions are pertaining solely to the cell therapy products and administration.
Investigational Cell Therapy Product Name
* must provide value
Does the investigational product (______ ) require a thaw time greater than 60 minutes?
* must provide value
Yes
No
Does the investigational product (______ ) expire less than 60 minutes from thaw time?
* must provide value
Yes
No
Are you requesting ClinImmune to support this study?
* must provide value
Yes
No
Does the study involve the use of immune cell therapy?
* must provide value
Yes
No
Heme or solid tumor?
* must provide value
Heme Solid Tumor
Is this an HCTU study?
* must provide value
Yes No
Does the study involve the use of CAR-T cells?
* must provide value
Yes
No
Type of immune cell therapy?
* must provide value
CAR-T Non-CAR-T Cancer Vaccine
What is the subtype?
* must provide value
TCR
TAC-T
TIL
Cancer Vaccine
non-T cell adoptive therapy
Does the study require lymphodepleting chemo?
* must provide value
Yes
No
Does the Cytoxan dose exceed 2000mg/m2?
* must provide value
Yes
No
Yes
No
IND Number (if known). If IND exempt, write "exempt." If the IND is not yet available, write "pending".
* must provide value
IND Holder Name
* must provide value
Name of person or entity holding the IND.
Has the DHHA Investigational Pharmacist been contacted regarding this study?
* must provide value
Yes
No
Is the compounding and/or local management of the investigational drug/biologic being managed by a pharmacy on the CU Anschutz Medical Campus (including the CHCO Investigational Pharmacy) or a UCHealth Pharmacy?
* must provide value
Yes
No
Where will the drug/biologic be locally managed?
* must provide value
You have indicated that the investigational drug/biologic will not be managed by one of the IDS pharmacies on the CU AMC. This will require additional review by Clinical Research Administration, who will reach out to you for any requests for additional information.
For studies involving investigational drugs at Denver Health, the Investigational Pharmacist must manage the drug.
All investigational drugs at CHCO must be managed by the CHCO Investigational Pharmacy.
For studies involving investigational drugs performed SOLELY at CU-AMC, the investigational drugs must be managed by the CU-AMC research pharmacy.
Will the investigational drugs be managed by the CU-AMC research pharmacy?
* must provide value
Yes
No
Will this study involve the investigation of a product regulated by the FDA as a device?
(e.g. implant, machine, instrument, some software programs, in vitro reagent)
* must provide value
Yes
No
Please provide the name of the investigational device:
Has the device been assigned an IDE-A/B designation by the FDA?
* must provide value
Yes
No
Yes
No
Please provide the HDE number
* must provide value
Has the device been assigned an IDE-A/B designation by the FDA?
* must provide value
No
Yes
Pending IDE A/B designation
Has the device been cleared by the FDA through the 510k process?
* must provide value
Yes
No
Is this a non-significant risk device?
* must provide value
Yes
No
Who holds the IDE?
* must provide value
Please provide the IDE number:
* must provide value
Does the study team plan to manage the ALL of the following for the investigational device: (______ )? ALL of the following:1. Receipt of the study device2. Oversight and accountability of the study device3. Dispensation or delivery of the study device to participants
* must provide value
Yes
No
Please provide a brief description of your intention (i.e. why is the study team managing the investigational device, where will it be stored/administered, etc.).
* must provide value
Where will the device be used (e.g., UCHealth, CHCO, or DH clinic)?
* must provide value
Please be as specific as possible.
Where will the device be stored?
* must provide value
Where will the investigational device (______ ) be stored?
* must provide value
Please list the other locations where the investigational device (______ ) will be stored.
* must provide value
Who will provide the investigational device (______ ) for this study?
* must provide value
Where will the investigational device (______ ) be used?
* must provide value
Please list the other locations for the investigational device (______ ) use.
* must provide value
Is the investigational device (______ ) part of UCHealth's existing commercial stock?
* must provide value
Yes
No
You will need to complete the ECCR process. If you have already submitted an ECCR, please provide your ECCR number:
Is the hospital required to purchase the device?
* must provide value
Yes
No
Please send the contract to UCHealth Research Administration (UCH-ResearchAdmin@uchealth.org).UCHealth Supply Chain via the Electronic Capital/Contract Requests system (ECCR) for review, processing and signature. Will you be receiving a device or equipment from a sponsor/vendor to be used as part of this study?
* must provide value
Yes
No
For CHCO studies using an investigational device, you MUST contact the Research Compliance Officer (David.Staley@childrenscolorado.org) to receive device documentation.
Will this study involve the use of a radioactive drug?
* must provide value
Yes
No
Will the radioactive drug be used to obtain basic information regarding the drug metabolism or human physiology, pathophysiology, or biochemistry, BUT NOT intended for immediate therapeutic, diagnostic, or similar purposes OR to determine the safety and effectiveness of the drug in humans?
* must provide value
Yes
No
RDRC approval is needed for you to conduct this research. Please contact the RDRC Office (RDRC@ucdenver.edu) for further information.
Will this study involve the use of recombinant or synthetic nucleic acid molecules (r/sNA) or biohazardous materials?
* must provide value
Yes
No
Will this study include ANY of the following?
Avian influenza virus
* must provide value
Yes
No
IBC approval is needed to conduct this research. Please contact the IBC Office (IBC@ucdenver.edu) for further information.
Will this study involve the use of any gene therapies?
* must provide value
Yes
No
Will this study involve the use of any other types of cell therapy?
* must provide value
Yes
No
Will this study involve the collection or use of human fetal/embryonic tissue?
* must provide value
Yes
No
Provide the source of the fetal tissue (e.g., your own patients vs. a sample repository).
Will this study involve the collection or use of placental tissue or cord blood?
* must provide value
Yes
No
Provide the source of the placental tissue or cord blood (e.g., your own patients vs. a sample repository).
Is this study designed solely to be a biobank to collect specimens and data?
* must provide value
Yes
No
Will specimens be housed on the UCD Anschutz Medical Campus?
* must provide value
Yes
No
Select all applicable specimen types.
* must provide value
supernatant
Aspirates
Bronchoalveolar lavage, supernatant
Bladder washing, neet
Bladder washing, pellet
Bladder washing, supernatant
Blood clot
Breath
Bronchial brushing, neet
Bronchial brushing, pellet
Bronchial brushing, supernatant
Bronchial washing trap, neet
Bronchial washing trap, pellet
Bronchial washing trap, supernatant
Bronchial washing, neet
Bronchial washing, pellet
Bronchial washing, supernatant
Buccal swabs
Buffy coat
Cell pellet
Cerebrospinal fluid
DNA
supernatant
Fine Needle Aspirate
Immortalized cells
PBMCs
Plasma
Primary culture
Protein
RNA
Saliva
Serum
supernatant
Stool
Tissue
supernatant
Whole blood
Anticipated number of specimens:
* must provide value
Specimen Storage Details, including research type, length of storage, and location
* must provide value
Who will review the OnCore BSM Build settings? (enter email address)
* must provide value
Is DHHA being used for recruitment only?
Yes
No
Which AMC UCHealth Outpatient Cancer Center Clinics?
Please list the "other" AMC outpatient cancer center clinics below
Expected Outpatient Clinics or Inpatient Units for Study Visits
* must provide value
You do not need to include radiology or laboratory services here.
Expected Outpatient Clinics for Study Visits
* must provide value
Expected Inpatient Units for Study Visits
* must provide value
Does the trial involve the use of the Apheresis Department?
* must provide value
Yes
No
Will Clinimmune be managing and dispensing the immune cell therapy product?
* must provide value
Yes
No
Does the study involve CAR T cells?
* must provide value
Yes
No
Has your protocol been reviewed by the Cellular Therapy and Immunotherapy Trials Committee? If no, please submit to Clay Smith and Wells Messersmith for review.
* must provide value
Yes
No
If the hospital's processing lab, ClinImmune, will need to be involved with this study, have they been approached yet?
* must provide value
Yes
No
Does the study protocol require pregnancy tests?
* must provide value
Yes
No
Does the study protocol require urine or serum pregnancy tests?
* must provide value
Urine Serum
Who will process/result the pregnancy tests?
* must provide value
Who will collect your participant's blood samples? Check all that apply. A piggyback sample is only used to collect additional research samples. Select this option if study team is collecting research labs from a conventional care blood draw done by clinical staff.
Select CTRC when blood draws are performed in Outpatient or Inpatient CTRC.
Select UCHealth if labs will be ordered in Epic.
* must provide value
Piggyback is additional blood taken for research purposes from a clinical blood draw or peripheral IV.
Which lab services are needed? Check all that apply. If local results are required by the protocol in addition to study tubes sent to a Sponsor Central Lab, select both: UCHealth Clinical AND Sponsor Central Labs/Study tubes
* must provide value
Will you need UCHealth lab to process (spin, prep) any samples that are sent to a sponsor central lab (e.g., PKs, Microbiology Lab Cultures, Hematology, Chemistry, Pregnancy tests, etc.)?
* must provide value
Yes
No
Will you need UCHealth lab to package and ship any samples that are to be sent to a sponsor central lab?
* must provide value
Yes
No
**this should not include labs processed and spun by CTRC labs
Does the PI or sponsor also want these central labs to be resulted by UCHealth Clinical Lab for safety reasons?
* must provide value
Yes
No
Who will ship tubes for Sponsor central labs (if not UCHealth)?
* must provide value
Study team
CTRC
Are you using UCHealth as a "central lab" - only processing samples collected outside UCHealth?
* must provide value
Yes
No
Fax number for lab reports:
* must provide value
Is this study requesting only the scan without a local read (i.e. "no read scan")? Answer yes to this question if you only If you answer yes to this question, the scan will be required to be paid for by the study and will not be read locally.
Is this study requesting only the scan without a local read (i.e. "no read scan")? Answer yes to this question if you only need the scan image.
Yes
No
If you answer yes to this question, the scan will be required to be paid for by the study.
What phantom scan modality do you need? (select all that apply)
To request a phantom scan to be completed at UCHealth, submit a request on this form here .
Please allow a minimum of 3 weeks from submission of the request for the requested scan to be completed. Phantom scans will be charged according to the current UCHealth research fee schedule.
* must provide value
Does the PI or sponsor also want these central labs to be analyzed locally for safety reasons?
* must provide value
Yes
No
Are you using UCHealth as a "central lab" - only processing samples collected outside UCHealth?
* must provide value
Yes
No
Expected Clinics for Study Visits
* must provide value
You do not need to include radiology or laboratory services here.
List items that you want UCHealth staff to perform for your visits.
* must provide value
Expected Time for Research Activities per Visit
* must provide value
Please define the range of time you expect each visit to take. Examples: "1-3 hours" or "3 hour screening, Rest 1 hour"
Will ANY data or materials be leaving Children's Hospital Colorado?
* must provide value
Yes
No
Will you be receiving ANY data or materials from another site?
* must provide value
Yes
No
Does the study team need to request an agreement for any of the following:
* must provide value
Please select all that apply.
In order to collect more information regarding your contracting needs, please complete the
Children's Colorado Agreement Intake Form . Please note this will open a link in a new window.
IRB Approval is required before your agreement will be reviewed. If you submit the Agreement Intake Form before IRB approval has been obtained, then you must upload a copy of your approval to start the review process. Note: if your study requires a Clinical Trial Agreement, Confidentiality Disclosure Agreement, or a Work Order under the MSA, please do not complete the Children's Colorado Intake Form. Most studies that involve the movement of data or materials requires some kind of agreement. Please explain why you do no believe an agreement is needed:
* must provide value
Will you be working with an external vendor for a service such as a data collection system (e.g. eCRF), sending surveys, other data or analytic services, specimen processing, etc.?
* must provide value
Yes
No
Is there an existing agreement in place associated with this group for conducting research?
* must provide value
Yes
No
Is this agreement with CHCO or CU?
CHCO
CU
Not Sure
Please indicate if you plan to use any of the following units for RECRUITMENT purposes:
* must provide value
Will you require or request the use of the CCHRI's short-term specimen storage located on the lower level of CHCO?
* must provide value
Yes
No
Do you require any custom Epic builds (i.e., for reporting or other purposes)?
* must provide value
Yes
No
Describe the floor and units where study activities will take place (e.g., 2nd Floor Cardiac Cath Lab):
* must provide value
CHCO Satellite Name:
* must provide value
For a current list of CTRC services and pricing, please click
here .
Choose all CTRC Cardiovascular Bioimaging Services requested for this protocol:
* must provide value
Please specify what type of ultrasound imaging is requested.
* must provide value
Is there a specialized echocardiogram manual (in development or finalized)?
* must provide value
Yes
No
Please upload the specialized echocardiogram manual.
Details of CHCO CTRC Nursing services will be provided via the CHCO Ancillary Services form that will follow the submission of the primary human subject research portal survey.
Specify the specific location of research visits
* must provide value
Specify location(s) of your research visits (check all that apply)
* must provide value
A medical provider with admitting privileges at UCH is needed for Inpatient CTRC visits. Please specify the provider name.
* must provide value
A medical provider is needed for medical oversight of the study activities and to sign the nursing orders for AHSB CTRC OP clinic . Please specify the provider name.
* must provide value
Specify the location(s) for mobile nursing.
* must provide value
Detail the CTRC services you wish to use. Please specify if inpatient and/or outpatient services will be utilized.
* must provide value
Please include details such as which visits, visit timing (e.g. only after hours visits, long PK days), expected duration of inpatient stays, etc.
Indicate if you will be using any of the commonly requested nursing procedures (check all that apply)
* must provide value
History and Physical Exam
* must provide value
CTRC APP as primary
Study Physician/APP only
Study Physician/APP as primary w/ CTRC APP as back-up
Vitals
* must provide value
CTRC Nursing as primary
Study Team only
Study team as primary w/ CTRC Nursing as needed
Phlebotomy
* must provide value
CTRC Nursing as primary
Phlebotomy Certified Study team member (Outpatient only)
Certified Study team member as primary w/ CTRC Nursing as needed
Sample processing
* must provide value
Study Team
CTRC Core Lab (AHSB)
UCH Clinical Lab (Beaker build required)
CTRC Nursing (Inpatient only
CTRC Nursing as primary
Study Team only
Study Team as primary w/ CTRC Nursing as needed
Medicine Administration
* must provide value
CTRC Nursing as primary
Licensed Study team member only
Licensed Study team member as primary w/ CTRC Nursing as needed
Check all Core lab services that apply:
* must provide value
For a list of tests and prices, please click here .
Please upload any lab manuals that you have with this HSRP submission.
Specify the visit numbers when CTRC Core Lab services are required
* must provide value
Specify the assays you would like the CTRC lab to run.
* must provide value
Who will be processing the samples (check all the apply)?
* must provide value
Other:
* must provide value
Who will be analyzing samples (select all that apply)?
* must provide value
Other:
* must provide value
Can samples be discarded after testing?CTRC Core Lab can hold samples and batch test them during the study, but is unable to store samples long term. If samples are not to be discarded after testing, please ensure an alternate arrangement is made for long term sample storage.
* must provide value
Yes
No
Check all Nutrition Core services that apply:
* must provide value
Which of the following nutrients will be controlled in the diet?
* must provide value
Specify the target amounts/limits for each nutrient:
* must provide value
Specify the type of diet record:
* must provide value
Written Diet Diary
Photographic Diet Diary
Food Frequency Questionnaire
24-hour Diet Recall
What specific growth parameters would you like measured?
* must provide value
At what time points would you like growth assessed?
* must provide value
Do you require calculation of z-scores?
* must provide value
Yes
No
What supplies will be provided by the sponsor?
Comments / Notes for CTRC Services:
completed PAF to send via HSR Portal
Protocol
* must provide value
Protocol Summary of Changes OR Redlined Protocol
* must provide value
Protocol Administrative Amendment/Clarification Letter
* must provide value
Draft internal budget
* must provide value
Draft contract
* must provide value
Amended CTA (please provide Word Document)
* must provide value
Investigator's Brochure or Manuals
Draft Informed Consent document
* must provide value
Protocol
* must provide value
Draft Consent Form (or Documentation of Waiver of Consent)
* must provide value
Draft Contract/Work Order/Written Agreement
* must provide value
Please upload Word version.
IIT Contracts Info Form
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Please upload the completed IIT Contracts Form in the field below.
Budget (draft okay, but financials will not be fully entered in OnCore until a fully executed contract and budget are received).
Investigator's Brochure #1
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Investigator's Brochure #2
Investigator's Brochure #3
FDA Approval Letter
Please provide IDE-A or IDE-B approval, 510K clearance, or 510k exempt
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Based on the information you've provided on this form, the following entities may need to review and approve your protocol before your research can begin.
The University of Colorado Cancer Center requires that all oncology-related studies be submitted to the Protocol Review & Monitoring System (PRMS) for review of scientific merit, priorities and progress prior to IRB review.here for PRMS submission instructions. Please submit this form the same day as the Protocol Assessment Form. CRAO or CHCO Contract Associates
UCDenver External IRB Coordinators
CHCO Colorado Child Health Research Institute (CCHRI)
Perinatal Research Facilitation Committee : In order to facilitate research with pregnant women and their infants at the Anschutz Medical Campus (AMC), and to be fair to all perinatal investigators involved in perinatal research, it is required that ALL potential perinatal research protocols be reviewed by the Perinatal Research Advisory and Facilitation Committee (PRAFC). The PRAFC is committed to fostering coordinated, multi-disciplinary, collaborative perinatal research.
There are additional UCHealth required surveys as part of the HSR Portal for this study.
The UCHealth Clinical Services Survey is required for this submission.
The UCHealth Study Team Managed Research Product Review survey is required for this submission.
The UCHealth Epic and Data Facilitation Survey is required for this submission.
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