UCLA DGSOM CLINICAL TRIALS ADMINISTRATION OFFICE
C O V E R A G E A N A L Y S I S : QUALIFYING CLINICAL TRIAL FORM (QCT FORM)
This form will determine if a Clinical Study is considered “qualifying” in accordance with the National Coverage Decision, policy
requirements of the UC Office of the President and UCLA Policy 915. Billing of “routine costs” to research subjects and/or third party payers
(including insurance providers) is limited to “qualifying” studies, unless approved in consultation with the Clinical Trials Administration Office
Principal Investigator (First, Last):
Study Contact/Coordinator (First, Last):
Department:
Select One
Protocol Title:
Sponsor / Funding Source:
SECTION 1:
Phase:
Select One
PRELIMINARY STUDY INFORMATION & FORM INSTRUCTIONS
Please indicate if the study is any of the following types of Non-Qualifying Studies:
Observational or Registry Study (no intervention or additional local labs/assessments)
Non-interventional study with additional central and/or local labs/assessments paid for by the study (if any local, CA Matrix required)
Investigational New Drug (IND) Study – study funding covers ALL protocol required items/services
IND-Exempt Drug Study – study funding covers ALL protocol required items/services (must complete QCT Supplement)
Investigational Device Study – study funding covers ALL protocol required items/services (must complete QCT Supplement)
If any boxes above are selected, STOP, study may qualify for abbreviated review. Please skip to SECTION 4 below, select Non-Qualifying
Clinical Trial and submit required documents to CTAO. Otherwise, please continue to SECTION 2 below.
SECTION 2: REQUIREMENTS FOR COVERAGE OF ROUTINE COSTS (CHECK ALL THAT APPLY)
1. Is the purpose or subject of the clinical trial to evaluate an item or service that falls within a Medicare benefit category,
and is not statutorily excluded from coverage?
YES
NO
2. Does the clinical trial have therapeutic intent (e.g. is not primarily exploratory or exclusively designed to test safety/toxicity)?
Please identify protocol objective that supports this:
YES
NO
3. Does the clinical trial enroll patients with a diagnosed disease or condition, rather than only healthy volunteers?
YES
NO
If NO is selected for any question in SECTION 2, STOP; the clinical trial does not qualify for coverage. ALL protocol required
items/services must be covered by study funding (e.g. no patient/insurance billing). Please skip directly to SECTION 4 below and
select “Non-Qualifying”. If YES is selected for ALL questions in SECTION 2, please proceed to SECTION 3 below.
SECTION 3:
AUTOMATICALLY QUALIFYING CLINICAL TRIALS (CHECK ALL THAT APPLY)
1. Funded by NIH, CDC, AHRQ, CMS, DOD and/or VA?
2. Funded by centers or cooperative groups supported by the agencies in §3.1 above?
YES
YES
NO
NO
3. Conducted under an Investigational New Drug (IND) application reviewed by the FDA?
4. Exempt from having an IND in accordance with FDA 21 CFR 312.2 (b)(1)?
YES
YES
NO
NO
If YES is selected to question 4, please complete the QCT Supplement. If YES is selected to any question in this Section (including
question 4), trial qualifies for coverage. Please complete a CA Matrix, and select “Qualifying Clinical Trial” in SECTION 4 below.
If NO is selected to all questions in this Section, STOP; trial does not qualify for coverage. All study costs must be provided by
sponsor/funding source. Please select “Non-Qualifying” in SECTION 4 below.
SECTION 4: C O N C L U S I O N & PI C E R T I F I C AT I O N
Qualifying Clinical Trial – Please complete CA Matrix.
PRINCIPAL INVESTIGATOR (SIGNATURE):
D O E S T H I S T R I AL Q U AL I F Y F O R C O V E R AG E ?
Non-Qualifying Clinical Trial – Sponsor/funding
source shall cover ALL study costs.
DATE:
PLEASE LEAVE BLANK – FOR CTAO INTERNAL PURPOSES ONLY
UCLA DGSOM QCT Form v.10 01 14
FOR INTERNAL PURPOSES ONLY © DGSOM Clinical Trials Administration Office 2012 – 2014