Download Questionnaire for New Clinical Research Studies Do not complete

Questionnaire for New Clinical Research Studies
Do not complete for Cancer Center Studies
Submit to [email protected]
Does the research study utilize UC Irvine Health items, services or locations?
Items and services include (but are not limited to) clinic visits with a physician or other care provider; laboratory,
radiology or other tests; medication administration and pharmacy services; office procedures; surgery or operating room
services; inpatient admission; use of a hospital bed; or emergency services.
☐ The study does not utilize UC Irvine Health items/services.
☐ The study uses UC Irvine Health items/services (specify): Click here to enter text.
Does the study use UC Irvine Health locations?
☐ The study does not use UC Irvine Health locations. Subjects will be seen at: Click here to enter text.
☐ The study uses the below UC Irvine Health locations (specify):
Orange
☐ Douglas Hospital
☐ Pavilion I-IV
☐ Manchester Pavilion
☐ Cancer Center
☐ Neuropsychiatric Center
☐ CDDC
☐ Outpatient Psychiatric Clinic
☐ Autism Center
Irvine
Other
☐ Gottschalk Medical Plaza
☐ UCI Satellite site: Click here to enter text.
☐ ICTS
☐ Non-UCI site: Click here to enter text.
☐ Medical Sciences A-E
☐ FQHC location: Click here to enter text.
☐ Medical Surge I-II
☐ Beckman Laser Institute
☐ Gavin Herbert Eye Institute
☐ Brain Imaging Center
☐ Centerpoint Psychiatric Clinic
If the study does not utilize UC Irvine Health items, services, or locations, please only complete the Protocol title and
Lead Researcher name, below.
Protocol Information
a.
b.
c.
d.
e.
f.
g.
h.
Protocol title: Click here to enter text.
Protocol nickname (optional): Click here to enter text.
Lead researcher name and email: Click here to enter text.
Research coordinator name and email: Click here to enter text.
Study contact name and email: Click here to enter text.
Department financial contact name and email: Click here to enter text.
Anticipated or actual date of IRB submission: Click here to enter text.
Is the study Investigator-Initiated?
☐ Yes, the protocol was authored by a UCI researcher.
☐ No, the protocol was externally authored (specify author): Click here to enter text.
Protocol Type (select one that best describes the investigational item)
☐ Interventional
☐ Observational/
registry
☐ Drug
☐ Device
☐ Biological/vaccine
☐ Procedure/Surgery
☐ Radiation
☐ Behavioral
☐ Gene transfer/stem cell/recombinant DNA
☐ Dietary supplement (e.g. vitamins, minerals)
☐ Other (specify): Click here to enter text.
☐ Data collection
☐ Statistical
☐ Population-based/epidemiology
☐ Behavioral
☐ Qualitative
☐ Longitudinal
☐ Other (specify): Click here to enter text.
☐ Expanded access
☐ Retrospective
☐ Biorepository
☐ Other (specify): Click here to enter text.
Treatment Setting (select all that apply)
☐ Acute/inpatient (including treatment)
☐ Ambulatory/outpatient (including follow up)
☐ Not applicable
☐ Short stay
☐ Surgical
Funding source
a. Will a research proposal be submitted to an extramural funding agency?
☐ Yes
If yes, select prime agency type
☐ Cooperative Group ☐ Federal ☐ Non-profit ☐ For-profit ☐ State/Local Government
If yes, select prime agency role
☐ Agent Source ☐ Data Analysis ☐ Study Design ☐ Funding Source
If yes, select level of review
☐Peer-reviewed ☐ Not peer-reviewed
If yes, specify agency: Click here to enter text.
If yes, specify Principal Investigator (if different from Lead Researcher): Click here to enter text.
If yes, specify subcontract sites, if any: Click here to enter text.
☐ No
If no, will an intramural research proposal be submitted? Specify: Click here to enter text.
If no proposal will be submitted, does the Chair approve department funding? Click here to enter text.
NCT Registration Requirement
a. Is the study an applicable clinical trial as defined by FDAAA 801?
☐ Yes
☐ No (if no, skip the next question)
b. Is the UCI Investigator the responsible party as defined by FDAAA 801?
☐ Yes
If yes, specify the NCT ID number: Click here to enter text.
☐ No
If no, specify the Responsible Party and NCT ID number: Click here to enter text.
Study Qualification under CMS National Coverage Decision
Which type of research is the study?
☐ Non-device
a. Does the study have therapeutic intent as a primary objective?
☐ Yes
Specify objective: Click here to enter text.
☐ No (if no, skip remaining questions)
b. Does the investigational item or service fall under a Medicare Benefit Category?
☐ Yes
Specify category: Click here to enter text.
☐ No (if no, skip remaining questions)
c. Does the study enroll patients with diagnosed disease?
☐ Yes
Specify disease: Click here to enter text.
☐ No (if no, skip remaining questions)
d. Is the study a deemed trial?
☐ Yes, it is funded directly by, or by centers/groups funded by NIH, CDC, AHRQ, CMS, DOD, or
VA
☐ Yes, it is conducted under an FDA-approved IND. Specify number: Click here to enter text.
☐ Yes, it is exempt from having an IND under 21 CFR 312.2(b)(1).
☐ No
☐ Device
a. What is the device name? Click here to enter text.
b. Specify the level of risk assigned by the IRB (leave blank if risk level is not yet assigned):
☐ Significant risk ☐ Non-significant risk
c. Does CMS allow coverage of the investigational device?
☐ Yes
☐ No
d. Is the device FDA approved and used on-label?
☐ Yes (if yes, skip remaining questions)
☐ No
e. Does the device have an investigational device exemption (IDE) under 21 CFR 312.2(b) (1)?
☐ Yes
Specify number: Click here to enter text.
☐ Category A devices: the contractor has determined the device is used for
diagnosis, monitoring or treatment of an immediate life-threatening disease or
condition
☐ Category B devices: the contractor has approved the use of the device.
☐ No
f. Does the device have a 510K exemption?
☐ Yes
Specify number: Click here to enter text.
☐ No
Specify whether contractor has approved billing for services: Click here to enter text.
☐ Observation
a. What is the general purpose of the trial? Click here to enter text.
b. What did you use to determine the study is observational? Click here to enter text.
c. What is the implication for Medicare Billing for the observational trial? Click here to enter text.
Please submit to [email protected] with the following supporting documents:
Standard documents
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Draft IRB application, narrative, and consent documents, and any other attachments
If the study is extramurally-authored, send the master protocol
If the study involves investigational drugs or devices, send the investigator brochure and FDA documentation
If the study utilizes UC Irvine Health items, services or locations, send the CRFA application
If a research proposal will be submitted to an extramural entity, send the internal budget and draft agreement
Ancillary Committee applications, as applicable
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If any of the study team members have a disclosable financial interest, send the COIOC application
If the study involves or investigates the use human pluripotent stem cells, send the hSCRO application
If the study involves human gene transfer, recombinant DNA, or infectious agents, send the Institutional Biosafety
Committee application
If the study uses any radioactive drug that is not FDA approved for the proposed usage and does not have an IND,
send the Radioactive Drug Research Committee application
If the study will expose human subjects to ionizing radiation from any radiological procedure or radioactive drug
that are not part of the patient’s routine care, send the Radiation Safety Committee application
If the study involves human subjects research conducted in UC Irvine Health surgical units, send the UCIMC OR
Committee application
If the study involves acquiring supplies or equipment for use at the Medical Center, send the value use committee
application