Today's Date
* must provide value
Today Y-M-D
Submitter First Name
* must provide value
Submitter Last Name
* must provide value
Submitter Email Address
* must provide value
Yes
No
Does this study require Scientific Peer Review (SRC or PRMS) by the Cancer Center?
* must provide value
Yes
No
Have your submitted the study to the PRMS/SRC committee at the Cancer Center?
Yes (upload the approval or exemption document below)
No
Please proceed with submitting your study/request to the PRMS (Peer review and monitoring system/committee) at the Cancer Center.
Link to SRC/PRMS Submission Form
Primary Management Group - Oncology
* must provide value
What services are you requesting?
* must provide value
Coverage Analysis is inherently included in all protocol shell and calendar build requests. Coverage Analysis Only = Study team built calendar, budget and protocol shell
Estimated Date of Study Opening in OnCore
Today M-D-Y Estimated Date = Site Activated, ready to begin recruiting
Does this study have any deadlines or due dates the CTMS Ops team should be aware of when creating the study in OnCore?
Describe Study Deadline/Due Date
Protocol Number
* must provide value
Protocol Number = UCD IRB Number
NCT Number
* must provide value
National Clinical Trials.gov number
Principal Investigator's Department
* must provide value
Anesthesiology Biochemistry and Molecular Medicine Dermatology Emergency Medicine Eye Center Internal Medicine Div Cardiovascular Internal Medicine Div Endocrinology Diabetes and Metabolism Internal Medicine Div Gastroenterology and Hepatology Internal Medicine Div General Medicine Internal Medicine Div Hematology and Oncology Internal Medicine Div Infectious Disease Internal Medicine Div Nephrology Internal Medicine Div Pulmonary, Critical Care and Sleep Medicine Internal Medicine Div Rheumatology, Allergy and Clinical Immunology MIND Institute Neurological Surgery Neurology Obstetrics and Gynecology Orthopaedic Surgery Otolaryngology Pathology and Lab Medicine Pediatrics Physical Medicine and Rehabilitation Psychiatry Public Health Sciences Radiation Oncology Radiology School of Nursing Surgery Urology Other
Must be the PI's HOME department
Please Describe
Study Site
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Project Title/Name
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Provide the full project or study title.
Study Short Title
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List the study short name or acronym.
Phase
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0
I
I/II
II
II/III
III
IV
N/A
Protocol Type
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Basic Science
Device Feasibility
Diagnostics
Expanded Access
Health Services Research
Prevention
Screening
Supportive Care
Treatment
Other
Please Describe
Investigator Initiated
* must provide value
Yes
No
Study Population
* must provide value
Adults
Children
Both
Is this a Multi-Site Trial?
* must provide value
Yes
No
Yes No
Protocol Target Accrual All Sites
* must provide value
All sites = Studywide Overall Enrollment Number
UCD Site Accrual Number
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UCD Total Enrollment Goal
UCD Site Accrual Duration
* must provide value
List Duration to Enroll in Number of Months
Anticipated Completion Date
* must provide value
Today M-D-Y Final date data will be collected for the last subject on the last visit
Anticipated Primary Completion Date
Today M-D-Y Study Wide Date that the last subject will have last intervention
Investigational Drug
* must provide value
Yes
No
N/A
If Yes, add IND#, If no add IDE#
List IND ID number, Holder's Name
* must provide value
Holder = Sponsor Name; if it is exempt list "Exempt"
List Investigational Device Exemption (IDE) number, Holder's Name
* must provide value
Holder = Sponsor Name; if it is exempt list "Exempt"
Primary Management Group - Medicine
* must provide value
PI First Name
* must provide value
Principal Investigator (first name and middle initial)
PI Last Name
* must provide value
PI Email
* must provide value
Lead CRC Name
* must provide value
CRC Role in Study
Lead Regulatory Coordinator Name
* must provide value
Regulatory/IRB Role for study
Finance Contact Name
* must provide value
Finance Role for study
Additional Study Staff; Provide Study Role, Name and Email
Department Contact for Calendar Review?
* must provide value
Provide name and email address
Department Contact for Coverage Analysis Review?
* must provide value
Please provide name and email address
Fund account number for the sponsor
Are there items or services that result in any charge or billing component (including billing to a third-party insurance, study sponsor, or patient) in the Epic billing system. Please describe:
* must provide value
CALENDAR/COVERAGE ANALYSIS INFORMATION
The OnCore Support Team will build the calendar/coverage analysis for this protocol but will not enter final financial information until a fully executed contract (FE CTA) and budget are received.
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 Schedule of events in table format can be helpful. You may use the Schedule of Events template below if your study does not include a schedule of events in the protocol.
Are you participating in the entire study?
* must provide value
Yes
No
N/A
Select No, if you are not participating in the entire study and only participating in certain arms, phases, etc.
Please describe which part of the study you will be participating in
Please describe which arms, cohorts, phases, etc. you are participating in. If you DO NOT want the entire study calendar to be built, please describe which visit you would like to start with.
32% Industry Interventional Studies (fully funded by one or more for-profit corporate entity)
42.5% Industry service agreements (service agreements typically includes data research without clinical interventions fully funded by one or more for-profit corporate entity)
60% Other Sponsored Projects (typically includes some/all govt funding)
Sample Collection Study
Comparative Treatment Study
Do not answer if not applicable
Does the study require items or services that are potentially billable to a subject or third party payor?
* must provide value
Yes
No
Subject or Third Party Payor Can Include a Patient or Patient's Insurance.
Do you want vendor payables set?
Yes
No
Provide vendor billables. (Vendor Payables = Costs incurred to the study such as IDS Fees, Radiology Fees, Stipends, etc.)
What is the salary amount for CRC (hourly)?
* must provide value
Include benefits
What is the salary amount for PI (hourly)?
* must provide value
Include benefits
Will you be utilizing the specification build in OnCore for sponsor invoicing?
Yes
No
specification/calendar sponsor invoicing on a subject level.
Is the study inpatient or outpatient?
* must provide value
Identify all clinical areas where research activities will or may take place (select all that apply).
* must provide value
Describe the clinic areas
* must provide value
Please specify if you have specific unit(s), department(s) or clinic(s) where the study visit and procedures should take place.
* must provide value
Will clinicians (RN, MD/DO, RT, APP, etc.) outside of the research team be asked to perform study procedures (assessments, vital signs, specimen collection)?
* must provide value
Yes
No
What types of procedures will clinicians outside of the research team perform? Select all that apply.
* must provide value
Describe procedures
* must provide value
Are there labs?
* must provide value
Yes
No
N/A
Are the labs local or central?
* must provide value
Must provide CROC form, if applicable
How will labs be drawn?
* must provide value
Who will draw labs?
* must provide value
Describe who draws labs
* must provide value
Yes
No
N/A
Where do PKs take place? How many time points?
Please describe
Are Radiology Services being utilized?
* must provide value
Yes
No
Where are Radiology services provided?
* must provide value
Must provide RSR/IRC Estimate
Will all study procedures be completed in the CCRC (not in conventional care locations)?
* must provide value
Yes
No
What CCRC resources will be utilized?
Please describe (labs, CCRC nurse, Staff, Clinic space, etc. CCRC Estimate must be provided)
What Cancer Center resources will be utilized?
Please describe labs, clinic space, Staff, etc.
Your study will now be routed for coverage analysis and QA check. Financial and Contract documentation are REQUIRED to perform coverage analysis. Please upload the protocol, budget, internal budget and FE CTA. We will reach out to you if we have any questions.
The following documents are required to be uploaded;
If your study is Pre - FE CTA;
If your study is post award include;
Please email the FE CTA (Fully Executed Contract), final budget or any other final documents to our team
email HS-CTMS OPS < HS-CTMSOPS@ucdavis.edu> if they are not available at time of your intake request submission.
Protocol
* must provide value
draft or final with version date
Contract/Grant documentation, Notice of Award, agreement, Scope of Work
Tip: Typically for department funded studies, Investigator Initiated Trials, Grant funded, NIH, etc.
Clinical Engineering Estimate
If you will be utilizing your own staff to do phlebotomy and/or process, add a comment in the additional comments
Schedule of Events Template
Must provide, if the protocol does not have a SOE included, Use the template above to create one if needed
SRC Approval or Exemption
Submit
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