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CRC Foundations - Funding, Financial Management, and Budgeting questions with answers.
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CRC Foundations - Funding, FinancialManagement, and Budgeting questions
with answers.
Classify the type of funding associated with a specific clinical trial. ANS - Federal Grants - Sponsorship
from the government which includes the NIH. Within the NIH there are 27 separate centers that gives
grants based on different criteria. (ex: Career Development Awards (K series), Program Project/Center
Grants (P series), Cooperative Agreements (U series), and Research Grants (R series))
Industry-Sponsored Trials - Sponsors in industry are usually used most when trying to get a new drug or
device on the market. Work with the FDA to get approval and make contracts with a research site to
enroll subjects and gather data. This contract is called a Clinical Trial Agreement.
Investigator-Initiated Trials with Industry Support - Similar to the Industry sponsored trials except that
you have a PI leading the trial with the industry providing some support during the trial. Each case of
how much support is dictated in the CTAs
Departmental and Organizational Funds - Funds from an org that research can pool from. In these
situations, these orgs usually have committees that makes funding decisions based on scientific merit or
liklihood of success. Usually used for smaller, early phase, pilot trials
Foundations - Funding from nongovernment/ nonprofit charity foundations, family foundations.
Research Consortia - Sponsorships for studies for rare diseases. They work to gather data from multiple
organizations for a specific research topic.
Distinguish between pre-award and post-award financial activities. ANS - Pre-Award: funding awarded
while the project is still in the proposal phase. Creating a budget and doing a coverage analysis is
important for getting this kind of funding
Post-Award: After being sponsored, activities include budgeting and making sure all expenses are
compliant.
, Explain what a coverage analysis is and why it is needed. ANS - Coverage Analysis is a way to find out
much of the subject care cost needs to be covered by the sponsor of the study. Important to have in
order to protect study compliance (bias from offering free services as part of the study). It also helps
figure out what can or can't be billed to Medicare or other 3rd party payers.
Demonstrate a basic understanding of Medicare Clinical Trials Policies. ANS - Clinical Trials Policy (CTP)
provides Medicare coverage for routine costs of qualifying clinical trials.
To qualify you must meet these requirements:
1. Evaluate an item or service that is included in a Medicare benefit category
2. Have therapeutic intent
3. Enroll subjects with diagnosed disease
4. Be "deemed" qualifying based on one of the following criteria:
- Funded by or centers that are funded by NIH, CDC, Agency for Healthcare Research and Quality
(AHRQ), the VA, or DOD
- Conducted under an Investigational New Drug (IND) application reviewed by the FDA
If the medical device is experimental: it is Category A and NOT covered by Medicare.
If the medical device is investigational: it is Category B and can be covered in certain circumstances
when the study is approved by the Centers for Medicare and Medicaid Services (CMS).
Medicare does not cover investigational drugs but, in some circumstances, does cover off-label use of
marketed drugs
Identify some of the challenges associated with clinical trial budget development. ANS - When coming
up with a budget, it is important to note all the extraneous activities/time required for the study when
determining a time estimate that goes into research involvement per participant.
Making note of extra costs associated with study procedures
Understanding both direct and indirect costs
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