Key Terms

When dealing with the application packet and other processes pertaining to the CRIS office there are some terms that might be ambigous at most and practical to remember at the least. We have compiled a list of key terms that can we hope you will find useful as you navigate this website.  

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z

-B-

Benefit Policy Manual (BPM) Provides general Medicare coverage instructions that are not National Coverage Determinations, (Pub. 100-02).

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-C-

Carriers The businesses contracted by Medicare to process claims and perform bill processing functions and benefit payment functions for the Part B, Supplemental Medical Insurance under section 1842 (a) of the Social Security Act.

Centers for Medicare and Medicaid Services (CMS) The agency within the Department of Health and Human Services (HHS). Created in 1977, CMS brought together the two largest Federal health care programs, Medicare and Medicaid under unified leadership. In 1997, the State Children’s Health Insurance Program (SCHIP) was established to address the health care needs of uninsured children. With a current budget of over $650 billion and serving approximately 90 million beneficiaries, CMS has become the largest purchaser of health care in the United States.

“CMS Strategic Action Plan 2006 – 2009.” Centers for Medicare and Medcaid Services, US Department of Health and Human Services. October 16, 2006. http://www.cms.hhs.gov/MissionVisionGoals/Downloads/CMSStrategicActionPlan06-09_061023a.pdf. Accessed 12/06/06.

Charge(s) The amount in the Charge Description Master that is the full amount that is charged to patients if there are no negotiated charges.

Clinical Investigation (FDA definition) Any experiment that involves a test article and one or more human subjects and that is one of the following: [21 CFR §50.3(c)] [21 CFR §56.102(c)]

• Subject to requirements for prior submission to the Food and Drug Administration under §505(i) or §520(g) of the act.
• Not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.

The term does not include experiments that are subject to the provisions of 1 CFR §58, regarding non-clinical laboratory studies.

Clinical Research Advisory Council A designated group of UM employees appointed by the Dean of UM SOM that resides over all matters relating to the establishment, implementation and monitoring of policies and processes regarding the Clinical Research Program.

Clinical Research Program All University of Miami (UM) employees who have a role in planning, funding, administration, management, and conduct of human subject research.

Clinical Research Study A clinical research study seeks answers to specific questions about vaccines, new drugs, new medical devices or new ways of using known treatments. Clinical research studies (also called medical research or clinical trials) are used to determine whether these potential new treatments are both safe and effective. Carefully conducted clinical research studies are the fastest and safest way to find treatments that work in people. For the purpose of this Policy, retrospective reviews of medical records and all other Human Subject Research are also included.

Clinical Trial Agreement (CTA) The written agreement or contract between the study sponsor (or Contract Research Organization working on behalf of the sponsor) and UM. For the purpose of this policy, this includes agreements between UM and government or private sponsors and subcontracts offered to UM by other entities (e.g. Universities) holding a primary contract with a sponsor. This document should contain information (exhibits or attachments) including the study protocol itself and the study budget.

Confidentiality Disclosure Agreement (CDA) A signed agreement by two parties restricting the distribution, use, dissemination, or other non-authorized use of confidential information in any form.

Conflicts of Interest Form An agreement that is required to be signed by the PI and Co-Investigator(s) certifying that none of the individuals named in the proposed project (or their spouse or dependant children) have a financial interest in the sponsoring agency or any organization involved in the project.

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-F-

Fiscal Intermediaries (FIs) The businesses contracted by Medicare to process claims and perform bill processing functions and benefit payment functions for the Part A, Hospital Insurance under section 1816 (a) of the Social Security Act.

Fully Allocated Cost The cost in the CDM that includes all cost allocations associated with the procedure.

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Human Subject (DHHS Definition) A living individual about whom an investigator (whether professional or student) conducting research obtains either a) data through intervention or interaction with the individual or b) identifiable private information [45 CFR §46.102(f)].

Human Subject (FDA Definition) An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient [21 CFR §50.3(g)].

Human Subjects Research Office (HSRO) Provides administrative support for the University of Miami Institutional Review Boards.

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Informed Consent Form (ICF) The document that is provided to the participant to describe the clinical trial’s purpose, objectives, investigational products, procedures, costs, risks, benefits, and relevant contacts.

Institutional Review Board (IRB) The federally mandated organization charged to protect the rights of human subjects that are involved in research. They must review each ICF from every clinical research study under their jurisdiction, and approve the ICF prior to use.

Institutional Review Committee (IRC) This is typically referred to as the Institutional Review Board (IRB). The federally mandated organization charged to protect the rights of human subjects that are involved in research. They must approve each ICF used by institutions under their jurisdiction.

Interaction Communication or interpersonal contact between investigator and subject. [45 CFR §46.102(f)(2)]

Internal Budget The detailed spreadsheet showing all events associated with a study, including UM’s costs and the amount charged to or negotiated with the sponsor.

Intervention Both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. [45 CFR §46.102(f)(1)]

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-L-

Local Coverage Determination (LCD) A local decision by the CMS contractor (i.e. the carrier and/or the fiscal intermediary with jurisdiction) on whether or not a particular item or service is a covered. This takes precedence over an NCD.

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-M-

Master Services Agreement The principal agreement between the study sponsor and UM governing the general terms and conditions for all subsequent Clinical Research studies. It does not include terms that are specific to a particular study or all of the financial terms of a particular study.

Medical Devices A Medical Device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease. Medical devices can be anything from thermometers to artificial hearts to at- home pregnancy test kits.

Medicare Coverage Analysis (MCA) A systematic review of protocol related documents to determine the appropriateness of billing Medicare for patient care costs incurred during a clinical research study. The documents reviewed are the protocol, sponsor agreement (contract) cost language of the informed consent form, FDA approvals and/or communications, and CMS contractor approvals or communications. See Medicare Coverage Analysis for Clinical Trials Policy for more information.

Medicare Rate The current amount reimbursed by Medicare for a procedure.

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-N-

National Coverage Decision (NCD) A determination by the CMS on whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act.

Negotiation The process through which two or more parties reaches an agreement on a proposed project, including the cost of the project and the scope of work to be performed.

Negotiation Floor A 20% premium above the fully allocated cost.

Notice of Grant Award (NOGA) Federal notice that states the amount of research funding for current and future years, start and end dates, and the terms and conditions of the award.

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-P-

Policy A written guideline conforming to or considered with reference to prudence, practicability, compliance with relevant regulations and which is consistent with UM’s mission.

Policy Author Person assigned to write a policy.

Policy Lead Person designated to chair the Clinical Research Advisory Council.

Private Information Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. [45 CFR §46.102(f)(2)]

Protocol The document used by the Principal Investigator (PI) and/or the IRC that describes the clinical trial’s purpose, objectives, investigational products, data collection requirements, participant population, procedures, reporting requirements, data analysis plan, and relevant contacts.

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-R-

Research (DHHS definition) A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR §46.102(d)]

Research involving Human Subjects Activities that are either a) Research, as defined in DHHS regulations, that involve Human Subjects, as defined in DHHS regulations; or b) Clinical Investigations, as defined by FDA regulations, that involve Human Subjects, as defined by FDA regulations.

Routine Costs Includes items and services:

• A Medicare benefit category exists;
• Covered by Medicare outside of a clinical trial;
• Typically provided absent a clinical trial (e.g., conventional care);
• Required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
• Needed for reasonable and necessary care arising from the provision of an investigational item or service--in particular, for the diagnosis or treatment of complications;
• Not investigational in nature;
• Not statutorily excluded;
• For which there is not a national non-coverage decision;
• Not provided solely to satisfy data collection and analysis needs and are not used in the direct clinical management of the participant (e.g., monthly CT scans for a condition usually requiring only a single scan); and
• Not customarily provided by the research sponsors free of charge for any enrollee in the trial.

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-S-

Sponsor Budget The document provided by the sponsor specifying the format for budget negotiations and as an attachment or exhibit to the CTA.

Subcontract The written agreement or contract offered by UM and affiliated sites of performance or non-UM-employed providers of research or clinical services who are participating in a clinical research study that originated either outside of UM or inside of UM (UM-initiated). For the purposes of this policy, a Subcontract offered to UM by an outside entity is treated no differently from any other CTA.

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-T-

Test Article Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act [21 CFR §50.3(j)] [21 CFR §56.102(l)].

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