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
Use additional comments section to detail further instructions for the CTMS Ops Team
Does this study require Scientific Peer Review (SRC or PRMS) by the Cancer Center?
Link to SRC/PRMS Submission Form
* must provide value
Yes
No
If no, your answer will lead you to the OnCore service path relevant to your request.
Have your submitted the study to the PRMS/SRC committee at the Cancer Center?
Yes (upload the approval or exemption document below)
No
If yes, (upload the approval or exemption document below) If no, please proceed with submitting your study/request to the PRMS (Peer review and monitoring system/committee) at the Cancer Center.
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
Indicate specific Oncology group that is primary to managing study. Typically relates to PI's home department.
What services are you requesting?
If building your own Protocol Shell, reference the Minimum Footprint Requirements to ensure you are completing all required fields.
* must provide value
Coverage Analysis is inherently included in all protocol shell, internal budget and calendar build requests. Coverage Analysis Only = Study team built calendar, budget and protocol shell
Estimated Date of Study Opening in OnCore(Estimated Date = Site Activated, ready to begin recruiting)
Today M-D-Y
Does this study have any deadlines or due dates the CTMS Ops team should be aware of when creating the study in OnCore?
Indicate specific deadlines or due dates related to urgency of completion by the CTMS Ops Team. Best practice: Submit within 2 months of opening study
What stage is the study currently in?
* must provide value
Start Up
SIV
Recruitment
Enrolling
Closed Enrollment
IRB Closed
Protocol Number
* must provide value
Must Include UCD IRB Number for studies in OnCore. You may use IRB # assigned to study even if submission is not complete.
Indicate National Clinical Trials.gov number when applicable. Search NCT number if not available. This is a required field in the Minimum Footprint requirements.
Principal Investigator's Department
* must provide value
Anesthesiology and Pain Med 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 Geriatrics 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 Physiology and Membrane Biology Psychiatry Public Health Sciences Radiation Oncology Radiology School of Nursing Surgery Urology Other
Must be the PI's HOME department
Describe other departments for Principal Investigator
Study Site
* must provide value
Indicate site(s) where study will primarily be managed. If "Other" list name of affiliate site below
List Other Participating Institutions
* must provide value
Name affiliate site(s)
Acknowledgement that affiliate site has documentation/authorization that the covered entity (affiliate) can give information (consents etc..) to outside researchers.
* must provide value
Acknowledge that affiliate sites have the proper documentation in consents for seeing patients at outside facility
Study Title/Name
* must provide value
Provide the full project or study title
Study Short Title
* must provide value
List study short name or acronym that you will be using to refer to study. Short tile is typically used to search study title in EMR. If utilizing Florence eBinders, short name should be same as OnCore short title and must be one to three acronyms
Phase
* must provide value
0
I
I/II
II
II/III
III
IV
N/A
Indicates Phase number typically referred to in study protocol
Indicates the type of protocol for reporting purposes
Other (chart review, data collection, registry, retrospective, etc.) Please Explain
* must provide value
Observational studies are further reviewed by CTMS Ops Team to define invoicing parameters and study build. Observational studies require further review and may take longer to process
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
Indicate yes or no depending on whether study is being conducted at multiple sites (e.g., institutions)
Yes No
If Yes - only summary subject data will be collected for a protocol. This enables the collection of subject accrual data summaries on the Accrual tab in PC Console
Protocol Target Accrual All Sites
* must provide value
All sites = Studywide Overall Enrollment Number
UCD Site Accrual Number
* must provide value
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
Is this an Investigational New Drug (IND) Study?
* must provide value
Yes
No
N/A
The IND acronym stands for Investigational New Drug application. It's a request submitted to the U.S. Food and Drug Administration (FDA) to get permission to start clinical trials
List IND ID number and Holder's Name
* must provide value
An IND number is the unique identifier assigned by the FDA to an Investigational New Drug (IND) application once it's submitted.Holder = IND owner
Is this an Investigational Device Study?
* must provide value
Yes
No
N/A
An investigational device is a medical device that is being tested in a clinical study but has not yet been approved (or cleared) by the FDA for general use in the U.S.
List IDE number and Holder's Name
* must provide value
An IDE number is the unique identifier assigned by the FDA to an Investigational Device Exemption (IDE) application.Holder = IDE owner
Upload the FDA Approval Letter
* must provide value
An FDA letter for an IDE (Investigational Device Exemption) is the formal written communication from the FDA that provides the outcome of the IDE submission. Request from Sponsor
CMS maintains a public list of IDE studies that have been approved for Medicare coverage. You can find this on the CMS Coverage IDE webpage or by searching: 👉 "CMS approved IDE studies site:cms.gov Or request from Sponsor or use link to website
Primary Management Group - Medicine
* must provide value
There can be more than one team/dept. managing a study. If there are, please specify in comments who the primary management group is.
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
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
Indicate fund account number for the sponsor when applicable
Indicate fund award/grant number
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
Describe services that will be billed in EMR. We need to further define these services for Coverage Analysis/Billing Grids/Compliance and auditing purposes
Attestation Statement: By opting to create a Florence e-binder for an industry-funded trial, you acknowledge and agree that the study account will be recharged $1,200. Research teams are highly encouraged to include this cost in their study budgets.
* must provide value
If you have any questions, contact the CTSC Florence team at HS-FLORENCEeBINDERS@ucdavis.edu
Florence eBinder Study Type
* must provide value
Industry Drug Trial Industry Device Trial Investigator initiated Trial
For Industry Observational Trials, please select Industry Drug as the Study Type
Please provide an account number until the study is awarded. You have 30 days after the study is awarded to provide study account number or this account will be charged.
* must provide value
Provide chart string for charging the $1200 Florence Fee
Florence Study Short Name
* must provide value
If utilizing Florence eBinders, short name should be the same as the OnCore short title and must be one to three acronyms
UCD IRB Number
* must provide value
This will be the Oncore Protocol Number
Yes
No
Activated = enrolling patients
Study Activation Date (started enrolling patients)
* must provide value
Today M-D-Y
Site ID
* must provide value
Enter NA if Site ID not provided by sponsor
Florence Department Admin - Provide Name and Email
* must provide value
Department Admin will be assigned to one to two study personnel. This role responsible for managing studies
Florence Regulatory Analyst - Provide Name and Email
Florence Clinical Research Coordinator - Provide Name and Email
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. 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.
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)
61% 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
Indicate the salary amounts to calculate internal budget costs for CRC. Include benefits
What is the salary amount for PI (hourly)?
* must provide value
Indicate the salary amounts to calculate internal budget costs for PI. Include benefits
Will you be utilizing the specification build in OnCore for sponsor invoicing?
Yes
No
Indicate if specification (calendar) build is needed for sponsor invoicing on a subject level.
Is the study inpatient or outpatient?
* must provide value
This info is used for calendar builds, Coverage Analysis, and to calculate internal costs,
Identify all clinical areas where research activities will or may take place (select all that apply).
* must provide value
If other, Describe the clinic areas
Describe other 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
Describe specific area
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
If "Other" describe procedures
Describe "other" procedures
* must provide value
Are there labs?
* must provide value
Yes
No
N/A
Indicate if UCD lab services are being utilized.
Are the labs local or central?
* must provide value
Indicate where UCD labs are being performed to assign CPT codes or calculate internal budget costs. Must provide CROC form, if applicable
How will labs be drawn?
* must provide value
Indicate how lab draws are being provided to assign CPT codes and/or calculate internal budget costs
Who will draw labs?
* must provide value
Indicate who is providing lab draws to assign CPT codes and/or calculate internal budget costs
Describe who draws labs
* must provide value
Yes
No
N/A
Indicate if PK draws are being provided to assign CPT codes and/or calculate internal budget costs.
Where do PKs take place? How many time points?
Describe where PKs are provided to assign CPT codes and/or calculate internal budget costs.
Are Radiology Services being utilized?
* must provide value
Yes
No
Indicate if UCD Radiology Services are being provided to assign CPT codes and/or calculate internal budget costs.
Where are Radiology services provided?
* must provide value
Indicate where Radiology Services are being provided to assign CPT codes and/or calculate internal budget costs. (e.g., Radiology/IRC) Must provide RSR/IRC Estimate
Will any study procedures be completed in the CTSC Clinical Research Center (CCRC) ?
* must provide value
Yes
No
If yes proceed to next question
What CCRC resources will be utilized?
* must provide value
Please describe (labs, CCRC nurse, Staff, Clinic space, etc. CCRC Estimate must be provided)
Will any 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 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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