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Glossary of Terms

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Patient

Individual seeking medical care.

Person

Any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or any other legal entity.

Pharmacoeconomics

The study of cost-benefit ratios of drugs with other therapies or with similar drugs. Pharmacoeconomic studies compare various treatment options in terms of their cost, both financial and quality-of-life. Also referred to as "outcomes research".

Pilot Study

Pilot studies, sometimes called feasibility studies, are conducted when additional information is needed on a product or on trial management and logistics before a larger-scale clinical study is begun. Pilot studies are usually single-center trials involving a limited number of subjects and are designed to accomplish any number of objectives within a clinical development program.

Pivotal Study

Pivotal trials of safety and effectiveness are larger, controlled studies designed most often as hypothesis-testing studies to support the submission of a premarket approval (PMA) application for a new device, a conformity assessment for CE mark registration in Europe, or a 510(k) premarket notification when clinical data are necessary to establish substantial equivalence.

Postmarketing Study

Postmarketing studies, like pilot studies, can vary in size and design, depending on the objective of the research. They can be narrow in scope when designed to gather additional information on a specific safety or performance issue. Other goals of postmarket research include performing comparative studies with alternative or competitive treatments or devices directed at providing support for pharmacoeconomic claims, comparative effectiveness claims, or failure analysis investigations.

PMA

Any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference. "PMA" includes a new drug application for a device under section 520(l) of the FD&C Act.

PMA amendment

Information an applicant submits to FDA to modify a pending PMA or a pending PMA supplement.

PMA supplement

A supplemental application to an approved PMA for approval of a change or modification in a class III medical device, including all information submitted with or incorporated by reference.

Postamendment device

A device that is commercially distributed on or after May 28, 1976, the date the Medical Device Amendments of 1976 were signed into law.

Preamendment device

A device that was commercially distributed before May 28, 1976, the date of the Medical Device Amendments of 1976 were signed into law.

Pre-Clinical Testing

Before a drug may be tested on humans, pre-clinical studies must be conducted either in vitro but usually in vivo on animals to determine that the drug is safe.

Premarket Approval (PMA)

A premarket approval means any premarket approval application for a Class III medical device, including all information submitted with or incorporated by reference therein. (21 CFR 814.3)

Premarket Notification [PMN or 510(k)]

510(k) refers to the type of submission to FDA described under 21 CFR 807 Subpart E in which the applicant must establish that their device is substantially equivalent to a legally marketed device. This type of submission is used for most Class II devices and some Class I devices.

Protection of Pupil Rights Amendment (PPRA)

Department of Education regulation that states that surveys, questionnaires and instructional materials for school children must be inspected by parents/guardians.

Protocol

A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before investigational drugs may be administered to humans.

Protocol Amendment

Changes or clarifications made in writing to the original protocol.

QS

Quality System, 21 CFR 820

Quality Assurance

Systems and procedures designed to ensure that a study is being performed in compliance with Good Clinical Practice (GCP) guidelines and that the data being generated is accurate.

Randomization

Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.

Reasonable probablity

That it is more likely than not that an event will occur.

Recruitment

Act of enrolling subjects with the proper inclusion criteria.

Recruitment Period

Time allowed to recruit all subjects for a study.

Regulatory Affairs

In clinical trials, the department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the entire drug approval process.

Research

Systematic investigation designed to develop or contribute to generalizable knowledge. Includes Clinical Research.

Research Team

Investigator, subinvestigator and clinical research coordinator involved with study.

Risk-Benefit Ratio

Risk to individual subject vs. potential benefits. Also called Risk-Benefit Analysis.

Safety Reports

FDA report required by investigator for any serious and unexpected adverse experience.

Serious Adverse Event (SAE)

Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged.

Serious, adverse health consequences

Any significant adverse experience, including those which may be either life.

Significant risk device (SR device)

Significant risk device is an investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise presents a potential for serious risk to a subject.

Single Project Assurance

Permit given to institution for single grant in compliance with government standards. See "assurance."

Source Data

All information contained in original records and certified copies of results, observations or other facets required for the reconstruction and evaluation of the study that is contained in source documents.

Source Documentation

Location where information is first recorded including original documents, data and records.

Sponsor

Individual, company, institution or organization taking responsibility for initiation, management and financing of study.

Sponsor-investigator

Sponsor-investigator is an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the investigational device is administered, dispensed, or used. The term does not, for example, include a corporation or agency. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor.

Standard Operating Procedure (SOP)

Official, detailed, written instructions for the management of clinical trials. SOPs ensure that all the functions and activities of a clinical trial are carried out in a consistent and efficient manner.

Standard Treatment

The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition.

Statement of material fact

A representation that tends to show that the safety or effectiveness of a device is more probable than it would be in the absence of such a representation. A false affirmation or silence or an omission that would lead a reasonable person to draw a particular conclusion as to the safety or effectiveness of a device also may be a false statement of material fact, even if the statement was not intended by the person making it to be misleading or to have any probative effect.

Sub-investigator

Helps design and conduct investigation at a study site.

Subject/Study Subject

Participant in a study. See "Human Subject."

Substantial Equivalence

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.

Telephone Report

Notification via telephone to the FDA of unexpected fatal or life threatening advent associated with a clinical study.

Transitional Devices

Transitional devices are devices that were regulated as drugs prior to the May 28, 1976, the date the Medical Device Amendments were signed into law. Any device that was approved by the New Drug Application process is now governed by the PMA regulations. The original NDA approval number is maintained.

Unanticipated adverse device effect

Unanticipated adverse device effect is any serious adverse effect on health or safety, any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Vulnerable Subjects

Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients).

Well-being

Subject's physical and mental soundness.

Withdrawal Application

Investigator/sponsor letter to FDA requesting application withdrawal when no additional work is envisioned.

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