Person completing form
* must provide value
Email address of person completing form
* must provide value
Did you submit your protocol through the UCD Human Subject Research Portal?
* must provide value
Yes
No
Is this a retrospective chart review?
* must provide value
Yes
No
Is this a secondary use of data project?
* must provide value
Yes
No
Is this a Flatiron Health project?
* must provide value
Yes
No
Is this secondary use of data project associated with a separate IRB-approved study?
* must provide value
Yes
No
Choose YES if you are obtaining data from an existing IRB-approved project. Choose NO if the data is from an existing database, i.e. SEER, EPIC, COMPASS, etc.
List COMIRB number from which you will be obtaining data.
* must provide value
List the Principal Investigator of the database from which you will be obtaining data.
* must provide value
The PI of this database provides their approval.
* must provide value
Yes
No
ONCORE: Do you plan to enter study subjects in OnCore for this project?
* must provide value
Yes
No
If you will not be entering subject detail into OnCore, you may be contacted by the Cancer Center's Reporting Team. Please provide more information on why subjects will not be entered into OnCore.
* must provide value
COMIRB Number-
To obtain a COMIRB number, click
here .
* must provide value
In instances where the project is QI, AND you have discussed it with COMIRB, AND COMIRB agrees that the project does not require their review, enter today's data and your initials here, in lieu of a COMIRB number.
Protocol Title
* must provide value
Please remove these special characters from the title: < > " ' &
Protocol Version Date
* must provide value
Today M-D-Y MM-DD-YYYY
Sites of Protocol Implementation and study visits
* must provide value
Select all that apply
Provide Other sites not listed above
Is this a repeat PRMS submission of a previously-disapproved protocol?
Yes
No
Principal Investigator
* must provide value
Sub-Investigators
* must provide value
If none, list "none".
Clinical Research Manager/ Project Manager
* must provide value
Primary Contact
* must provide value
Regulatory Contact
* must provide value
Finance Pre-Award Contact
N/A if not applicable
Finance Post-Award Contact
N/A if not applicable
Primary team implementing and accruing subjects to protocol (Management Group)
* must provide value
Other CU- Boulder CC- Breast CC- Children's Hospital CC- Colorado Springs CC- CTRC CC- Dermatology CC- Endocrinology CC- Gastroenterology CC- Genetics CC- GYN CC- Head & Neck SPORE CC- Heme - BMT CC- Infectious Disease CC- Lung SPORE CC- Neuro Oncology CC- Northern Colorado CC- OCRS Team CC- ORIEN CC- Otolaryngology CC- Outreach CC- Pathology/ Tissue Bank CC- Pharmacy CC- Prevention and Control CC- Pulmonary CC- Radiation Oncology CC- Radiology CC- Sarcoma CC- Surgical Oncology CC- Survivorship CC- Urology Oncology CC- Veterans Affairs CC- Young Women's Breast Cancer CCTO - RAC/ Finance CCTO- Brain CCTO- Breast CCTO- Endocrine CCTO- GI CCTO- GU CCTO- GYN CCTO- Head & Neck CCTO- Lung CCTO- Melanoma CCTO- POEMS CCTO- Radiation Therapy CCTO- Sarcoma CHCO- Surge CHCO- Neuro-Onc CHCO- Hematology CHCO- ETP CHCO- COG CHCO- BMT Med-Hem-BloodMarrowTransplant Med-MedicalOnc
Choose Other if unsure. CC=Cancer Center. CCTO=Cancer Clinical Trials Office
You chose CC-Children's Hospital. Does your group fall into one of these specific CHCO categories?
* must provide value
CHCO- Surge
CHCO- Neuro-Onc
CHCO- Hematology
CHCO- ETP
CHCO- COG
CHCO-BMT
None of the above applies.
Is this study accruing patients at the VA only?
* must provide value
Yes
No
Is there more than one Cancer Center team working on the protocol?
* must provide value
Yes
No
Other team working on protocol (Management Group)
* must provide value
Other CU- Boulder CC- Breast CC- Children's Hospital CC- Colorado Springs CC- CTRC CC- Dermatology CC- Endocrinology CC- Gastroenterology CC- Genetics CC- GYN CC- Head & Neck SPORE CC- Heme - BMT CC- Infectious Disease CC- Lung SPORE CC- Neuro Oncology CC- Northern Colorado CC- OCRS Team CC- ORIEN CC- Otolaryngology CC- Outreach CC- Pathology/ Tissue Bank CC- Pharmacy CC- Prevention and Control CC- Pulmonary CC- Radiation Oncology CC- Radiology CC- Sarcoma CC- Surgical Oncology CC- Survivorship CC- Urology Oncology CC- Veterans Affairs CC- Young Women's Breast Cancer CCTO - RAC/ Finance CCTO- Brain CCTO- Breast CCTO- Endocrine CCTO- GI CCTO- GU CCTO- GYN CCTO- Head & Neck CCTO- Lung CCTO- Melanoma CCTO- POEMS CCTO- Radiation Therapy CCTO- Sarcoma CHCO- Surge CHCO- Neuro-Onc CHCO- Hematology CHCO- ETP CHCO- COG CHCO- BMT Med-Hem-BloodMarrowTransplant Med-MedicalOnc
CC=Cancer Center. CCTO=Cancer Clinical Trials Office
You chose CC-Children's Hospital. Does your group fall into one of these specific CHCO categories?
* must provide value
CHCO- Surge
CHCO- Neuro-Onc
CHCO- Hematology
CHCO- ETP
CHCO- COG
CHCO-BMT
None of the above applies.
What is the OCRST role on this study?
* must provide value
Other team working on protocol (Management Group)
Other CU- Boulder CC- Breast CC- Children's Hospital CC- Colorado Springs CC- CTRC CC- Dermatology CC- Endocrinology CC- Gastroenterology CC- Genetics CC- GYN CC- Head & Neck SPORE CC- Heme - BMT CC- Infectious Disease CC- Lung SPORE CC- Neuro Oncology CC- Northern Colorado CC- OCRS Team CC- ORIEN CC- Otolaryngology CC- Outreach CC- Pathology/ Tissue Bank CC- Pharmacy CC- Prevention and Control CC- Pulmonary CC- Radiation Oncology CC- Radiology CC- Sarcoma CC- Surgical Oncology CC- Survivorship CC- Urology Oncology CC- Veterans Affairs CC- Young Women's Breast Cancer CCTO - RAC/ Finance CCTO- Brain CCTO- Breast CCTO- Endocrine CCTO- GI CCTO- GU CCTO- GYN CCTO- Head & Neck CCTO- Lung CCTO- Melanoma CCTO- POEMS CCTO- Radiation Therapy CCTO- Sarcoma CHCO- Surge CHCO- Neuro-Onc CHCO- Hematology CHCO- ETP CHCO- COG CHCO- BMT Med-Hem-BloodMarrowTransplant Med-MedicalOnc
CC=Cancer Center. CCTO=Cancer Clinical Trials Office
You chose CC-Children's Hospital. Does your group fall into one of these specific CHCO categories?
* must provide value
CHCO- Surge
CHCO- Neuro-Onc
CHCO- Hematology
CHCO- ETP
CHCO- COG
CHCO-BMT
None of the above applies.
What is the OCRST role on this study?
Study Phase
* must provide value
Pilot Feasibility Phase I Phase I/II Phase II Phase II/III Phase III Phase III/ IV Phase IV Retrospective chart review N/A. Examples: epidemiologic, cancer control, behavioral, observational, ancillary/ correlative
Is this a multi-center study? For example, will the study be opened at more than one center?
* must provide value
Yes
No
What is the name of the coordinating center and/ or operations center (institution, drug company, cooperative group)? For example, who has control of the study?
Does this study require consent of subjects?
* must provide value
Yes
No
Age Group
* must provide value
Children
Adults
Both Children and Adults
IRB of Record
* must provide value
COMIRB
WIRB
CIRB
Other
List NCI Cooperative Group
* must provide value
List Other IRB
* must provide value
Anticipated IRB Review Type
* must provide value
Full Board
Expedited
Exempt
Provide brief description of study
* must provide value
Is this study part of the Lead Academic Participating Sites (LAPS) grant?
* must provide value
Yes
No
Is this study part of the UM1 grant?
* must provide value
Yes
No
Was this study reviewed by the Cancer Center IIT Review Committee?
* must provide value
Yes
No
Do you have a mentor for this study?
* must provide value
Yes
No
List Mentor name and title.
* must provide value
Is this study related to non-malignant disease (i.e. cardiovascular studies, neurologic disorders, etc.)
* must provide value
Yes
No
Please specify the non-malignant disease/ cancer relationship
* must provide value
Is this an Expanded Access Protocol?
* must provide value
Yes
No
Is this a Pilot study?
* must provide value
Yes
No
Is this study planning to use the Oncology Research Information Exchange Network (ORIEN)? Prior approval from ORIEN is required. Submit your project for review
here .
* must provide value
Yes
No
NCT ID#
* must provide value
Please provide if available. If not, enter N/A.
Date Research Team received PROTOCOL from sponsor
* must provide value
Today M-D-Y
Date Research Team received CONTRACT from sponsor
Today M-D-Y
Date Research Team received BUDGET from sponsor
Today M-D-Y
Is this study fully funded?
* must provide value
Yes
No
Does this study NOT require external funds? For example, study is retrospective chart review, or student project. Please explain.
* must provide value
Do you anticipate receiving funds in the future? Please describe in detail.
* must provide value
Initiator of study
* must provide value
Industry
Investigator-Initiated
Other
Is the lead investigator local or from another site?
* must provide value
Local PI wrote the protocol
Originally initiated at external institution
Participating Sites
* must provide value
List all sites invited to participate in this study.
Biostatistician Name
* must provide value
Biostatistician who evaluated the sample size and data analysis plan. List N/A if not applicable.
What entity initiated the study?
* must provide value
What site is the lead investigator from?
* must provide value
Protocol number
* must provide value
If no number, insert COMIRB number.
Have you or will you receive Grant funding for this study?
* must provide value
Yes
No
Describe the grant funding, i.e. R01, K, Cancer Center, or other grant
* must provide value
Is an IND required for this Protocol? More information about an IND can be found here:  IND .
* must provide value
Yes
No
Not Applicable.
An IND is an Investigational New Drug Application.
What is the status of your IND application?
IND application has not yet been submitted to the FDA. It will be submitted after PRMS approval.
IND application has been submitted to the FDA. We are in the 30-day waiting period.
IND application has been submitted and the 30-day waiting period has passed.
Other
Did the UC Denver IND/ IDE office assist you with the IND/ IDE submission?
Yes
No
Who assisted you with IND submission?
List the name or the entity that holds the IND.
* must provide value
Provide reason for choosing "IND is Not Applicable"
* must provide value
If there is currently no IND, will one be submitted?
* must provide value
Yes
No
Anticipated submission date for IND request
* must provide value
Is the protocol IND exempt?
* must provide value
Yes
No
Who granted the exemption?
* must provide value
Will an exemption be requested?
* must provide value
Yes
No
Date IND exemption requested
* must provide value
Provide estimated date if in the future.
Name of person or entity holding the IND.
NCI Study Designation
* must provide value
Treatment: Protocol designed to evaluate one or more interventions for treating a disease, syndrome, or condition.
Supportive Care: Protocol designed to 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. Supportive care interventions are not intended to cure a disease.
Diagnostic: Protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition.
Screening: Protocol designed to 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: Protocol designed to assess one or more interventions aimed at preventing the development of a specific disease or health condition.
Basic Science: Protocol designed to examine the basic mechanism of action (ex., physiology, biomechanics) of an intervention.
Health Services Research: Protocol designed to evaluate the delivery, process, management, organization, or financing of health care.
Other: Not in any category listed above.
Select one.
Type of research
* must provide value
Interventional: The participants may receive diagnostic, therapeutic, behavioral or other types of interventions such as prevention, supportive care or participants are followed and biomedical and/or health outcomes are assessed.
Observational: Studies focus on cancer patients and healthy populations that involve no intervention or alteration in the status of the participants. Biomedical and/or health outcome(s) are assessed in pre-defined groups of participants.
Ancillary or Correlative Studies: Ancillary studies must be linked to an active clinical research study and should include only patients accrued to that clinical research study. Correlative studies are laboratory based studies using specimens to assess cancer risk, clinical outcomes, response to therapies, etc.
Not Applicable
PRMS requires the final protocol be submitted for review. Has this protocol been reviewed and approved by the FDA for moving forward?
* must provide value
Yes
No
You selected NO above. Please provide an explanation.
* must provide value
Since this is an interventional, investigator initiated trial, it is highly suggested that your study be evaluated by the Cancer Center IIT Committee. Was this done?
* must provide value
Yes
No
Date of IIT Review
* must provide value
Today M-D-Y MM-DD-YYYY
Is this a survivorship/ palliative care protocol?
* must provide value
Yes
No
Type of survivorship/ palliative care protocol
* must provide value
Treatment Summary/ Care Plans
Palliative Care
Health Outcomes
Behavioral Interventions
Side Effects Management
Is this a Precision Trial (targeted therapy)?
* must provide value
Yes
No
A precision trial includes treatments that target specific genetic mutations or molecular pathways.
Type of Precision Trial
* must provide value
Basket: for trials that allow the study of multiple molecular subpopulations of different tumor or histologic types all within one study. These trials can include highly rare cancers that would be difficult to study in randomized controlled trials, and they might include multiple treatments by which subjects are matched based on gene expression. Ex. MATCH study
Umbrella. For trials using a design that focuses on a single tumor type or histology. It involves a group of two or more enrichment designs, or sub-studies, that are connected through a central infrastructure that oversees screening and identification of patients. Ex. ALCHEMIST, Lung-MAP
Target. For trials designed to evaluate treatments targeted at one or two molecular populations in single or multiple disease types.
Other Adaptive Trials. For other studies believed to be precision medicine trials based on non-traditional study design not identified above, limited inclusion criteria, and emphasis on patient-centric treatment.
Does this trial involve immunotherapy?
* must provide value
Yes
No
Select the immunotherapy type(s).
* must provide value
Will you require local Pathology services?
* must provide value
Yes
No
Describe Pathology services needed.
* must provide value
Ensure that pathology is aware of your needs prior to submitting your project thru this form. Contact the Department of Pathology Services at BCF.Admin@cuanschutz.edu.
Source of Project
* must provide value
Externally Peer Reviewed. Includes studies sponsored by the NCI, other NIH Institutes, the DoD, CDC, VA, FDA, ACS, LLS, Komen, Prevent Cancer Foundation, Multiple Myeloma Research Foundation, and the Melanoma Research Alliance. NCI - include all CTEP-reviewed studies, all studies funded by the NCI, and all studies associated with the ET-CTN UM1, P2C, SPORE, and the NW Chemoprevention Consortium.
National Group. Includes all National Clinical Trials Network (NCTN) studies including COG, Alliance, SWOG, NRG, ECOG-ACRIN and the Canadian Network Group.
Institutional. Includes studies designed with significant input from you, your internal or external colleagues including those supported by UCCC, or other institutional and/or philanthropic support.
Industry. Studies designed and controlled by industry sponsors
Select one.
Select Diseases studied-
* must provide value
If disease not listed, specify here.
If Pre-Cancer, specify here.
* must provide value
Was a CU Cancer Center member significantly involved in designing the protocol?
* must provide value
Yes
No
Describe the specific involvement in the study, i.e. authored study, steering committee member, advisory committee member,etc.
* must provide value
Name of CU Investigator who designed the protocol
* must provide value
Is a CU Cancer Center member the overall coordinating principal investigator for this multi-center study?
* must provide value
Yes
No
Name of overall coordinating PI
* must provide value
Will CU Cancer Center investigators be conducting key ancillary or correlative analyses for this protocol?
* must provide value
Yes
No
Describe what key analyses will be performed
* must provide value
Whose lab(s) will perform the analyses?
* must provide value
Is there any aspect of this study (ex. use of a specific therapy or a combination of therapies; recruitment of a specific population or sub-population; etc) that is based on data derived from research by a CU Cancer Center Investigator?
* must provide value
Yes
No
Name the CU Cancer Center Investigator(s) and describe their contribution to the data on which this trial is based.
* must provide value
Are there other notable contributions from CU Cancer Center Investigators to this protocol?
* must provide value
Yes
No
Name the CU Cancer Center Investigator(s) and describe their contribution.
* must provide value
I attest to the information on PI involvement above. Information must match that found in PDF document.
* must provide value
Name of Person Signing
* must provide value
Will this study have a non-CU Cancer Center review of patient safety (adverse event trends, severe adverse events), protocol compliance, and statistical endpoints (early stopping rules, efficacy assessments)?
* must provide value
Yes
No
N/A. This study is non-therapeutic.
Indicate the page number in the protocol that describes the data safety monitoring.
* must provide value
Provide a description of the data safety monitoring plan from the protocol.
* must provide value
Is the Data Safety Monitoring Plan internal or external?
* must provide value
Internal
External
Will the protocol include the collection of any research specimens (i.e. PK samples, or additional tissue collection outside of routine care?)
* must provide value
Yes
No
Will tissue be stored (banked) locally?
* must provide value
Yes
No
List storage location.
* must provide value
"External" if sponsor banks it. "Local" if housed on campus - list specific location on campus.
Your submission will be returned if DSM language is not up to date! Confirm that DSMC template language has been inserted.
This study is a local investigator initiated trial. Data Safety Monitoring template language must be inserted into the protocol prior to PRMS submission. Template language can be found here: https://medschool.cuanschutz.edu/colorado-cancer-center/clinical-trials/dsmc
* must provide value
Yes
No
Contact dsmc@cuanschutz.edu for any questions regarding DSMC template language.
Protocol target accrual nationally
* must provide value
Anticipated number of subjects to be enrolled ON STUDY locally
* must provide value
Anticipated number of CONSENTED subjects
* must provide value
Anticipated local ANNUAL accrual goal
* must provide value
Accrual will be reviewed by PRMS for interventional studies beginnig at six months from date Open. Warning letters will be sent for low accruing trials (< 50% of goal).
Number of patients seen in the past year that would potentially qualify for this trial
* must provide value
Will other Regions be participating in this trial?
* must provide value
Yes
No
Provide anticipated number of subjects ON STUDY for each participating region.
* must provide value
List the number of patients seen at each region in the past year that would qualify for this trial.
* must provide value
Protocol-defined accrual duration (in months)
* must provide value
Does your clinical trial or research project aim to recruit Underrepresented Minorities (URM) & Hispanic/Latino patients?
* must provide value
Yes
No
Will the sponsor allow the informed consent or short form to be translated into languages other than English?
* must provide value
Yes
No
You answered "No" to the previous question. Please provide reason.
* must provide value
Are study documents provided to patients in languages other than English? For example, diaries, Quality Of Life questionnaires, surveys.
* must provide value
Yes
No
You answered "No" to the previous question. Please provide reason.
* must provide value
The Office of Community Outreach and Engagement (COE) offers free English-to-Spanish translation of study-related documents for studies aiming to recruit Spanish-speaking participants. If this is your goal, would you like assistance with translation of study documents?
* must provide value
Yes
No
In what languages are study documents provided?
* must provide value
Are there studies that compete with this one for enrollment? List yes for any studies that enroll the same patient population, as listed on schema.
* must provide value
Yes
No
If this is a treatment study and schema lists studies enrolling the same disease population, must choose YES. Incorrect submissions will be returned to the submitter and cause a delay in review.
List competing studies by IRB#. List each study that competes for the same patient population according to your schema. Â
For each study, provide the following:Â
IRB# Date Open to Accrual Total Number of patients enrolled * must provide value
How will you determine the enrollment to this and other studies that compete for the same patient population? List a specific plan for prioritizing competing studies.
* must provide value
Provide justification for opening this study in the context of the competing studies listed above.
* must provide value
Additional barriers to enrollment: select all that apply.
* must provide value
List Other Barriers
* must provide value
You checked LOWER or HIGHER than the Colorado State averages in one or more of the groups above, please provide an explanation for this selection.
* must provide value
List the names of the clinics where recruitment will occur. Please list all potential clinics, be specific, i.e. Phase 1, radiation oncology, urologic oncology, etc.
* must provide value
What age groups will you recruit? Select all that apply.
* must provide value
What gender(s) will you recruit?
* must provide value
Which populations will be more difficult for you to recruit?
* must provide value
Attached is a listing of resources provided by the Office of Community Outreach and Engagement (COE). Contact COE staff at engagecucancercenter@cuanschutz.edu for further guidance.
What constraints exist to recruiting the disparity populations you list above? Check all that apply.
* must provide value
The Office of Community Outreach and Engagement (COE) offers free English-to-Spanish translation of study-related documents for studies aiming to recruit Spanish-speaking participants. COE prioritizes Investigator-Initiated studies. If this is your goal, would you like assistance with translation of study documents?
* must provide value
Yes
No
Consult the resource list attached for how to recruit a diverse population. engagecucancercenter@cuanschutz.edu.
What is your plan for reducing access barriers and increasing recruitment and retention of diverse populations?
* must provide value
What is your plan for reducing language or literacy barriers and increasing recruitment and retention of diverse populations?
* must provide value
What is your plan for reducing cultural or religious barriers and increasing recruitment and retention of diverse populations?
* must provide value
What is your plan for reducing other barriers and increasing recruitment and retention of diverse populations?
* must provide value
Would you like assistance from the Cancer Center Office of Community Outreach and Engagement (COE) with providing strategies and resources for recruiting underrepresented populations to your study?
* must provide value
Yes
No
Please list the specific assistance you would like the COE group to provide.
* must provide value
List reasons why this project is important to the field, institution, primary department/ service and the PI.
* must provide value
List Other reason this project is important.
* must provide value
Protocol
* must provide value
Be sure the protocol contains the COMIRB#, Version Date, PI Name and Study Title. COMIRB application is accepted for retrospective chart reviews.
Required for study using investigational agents.
Study Schema of team's studies.
* must provide value
Hard Copy Required. Instructions on schema development can be found on the PRMS website.
Study Funding Plan
* must provide value
PRMS Signature page document. Sign and attach in the next section below.
Attach PRMS Signature Page document.
* must provide value
Hardcopy signatures are acceptable. Signature for PI and Disease Site Leader cannot be the same. No Disease Site Leader signature is required for retrospective chart reviews.
Affiliate PI Signature Page. Affiliate PI sign and attach in the next section.
Attach signed Affiliate PI Signature page (LAPS studies only).
Hardcopy signatures are acceptable.
Study Schema of Affiliate Team Studies (LAPS only)
Instructions on schema development can be found on the PRMS website.
PI Involvement page. PI sign and attach in the next section below.
Attach signed PI Involvement page.
* must provide value
Hardcopy signatures are acceptable.
LAPS Approval form
* must provide value
LAPS Protocol Information Sheet
* must provide value
Attach IIT Committee Approval Letter
* must provide value
Attach Summary of Changes and/or response letter to PRMS
* must provide value
This should be related to the previous PRMS disapproval.
Secondary Use PI Signature page. Original PI sign and attach in the next section below.
Attach Secondary Use PI Signature Page.
Attach if you are requesting data from another local PI's project. Hardcopy signatures are acceptable.
Attach NIH Notice of Award letter.
* must provide value
Please provide if available.
Attach the Flatiron Health approval letter.
* must provide value
Attach the Clinical Monitoring Plan.
* must provide value
Attach ORIEN approval letter.
* must provide value
Other attachment (as needed). Submit additional documents including appendices, questionnaires, surveys, list of data fields being studied, etc. to allow adequate review by the committee.
Other attachment (as needed)
Other attachment (as needed)
Other attachment (as needed)
Other attachment (as needed)
Date Submitted to PRMS
* must provide value
Today M-D-Y MM-DD-YYYY
Submit
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