Glossary of Terms:
30 Day PMA Supplement
A supplemental application to an approved PMA in accordance with 21 CFR 814.39(e).
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.
Federal Food, Drug, and Cosmetic Act (sections 201
Adverse Event (AE)
A negative experience encountered by an individual during the course of a clinical trial, is associated with the medical device. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction.
Adverse Event Reports
Investigator reports of all serious and adverse events, injury and deaths given to the sponsor, the IRB and the FDA.
U.S. Food and Drug Administration
Application Integrity Policy (AIP)
Application Integrity Policy (AIP) is FDA’s policy for the integrity of data or information submitted in an application. If it is suspected that an applicant has submitted false or misleading information, the data are thoroughly investigated. Submitting false or misleading information may result in FDA refusal to review submissions until certain requirements are met.
A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.
Any technique that uses living organisms, or substances from organisms, biological systems, or processes to make or modify a product or process, to change plants or animals, or to develop micro-organisms for specific uses.
Case Report Form (CRF)
A record of pertinent information collected on each subject during a clinical trial, as outlined in the study protocol.
Code of Federal Regulations
A systematic study designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product’s benefits relative to its risks. Clinical investigations can only be conducted with the approval of the Food and Drug Administration (FDA).
Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. Note that in this manual, this term is used in its narrow sense as used by the FDA. Thus, it does not encompass all the research that is carried out in the clinical setting (e.g., health services research).
Clinical Research Associate (CRA)
Person employed by the study sponsor or CRO to monitor a clinical study at all participating sites. See also, monitor.
Clinical Research Coordinator (CRC)
Site administer for the clinical study. Duties are delegated by the investigator. Also called research, study or healthcare coordinator, and data manager, research nurse or protocol nurse.
Clinical Study Materials
Study supplies (i.e., study test article, laboratory supplies, case report forms) provided by the study sponsor to the investigator.
Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent’s safety and efficacy.
1991 agreement to cover all federal-sponsored research by a common set of regulations.
A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject.
Contract Research Organization (CRO)
A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s study-related duties and functions.
A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
This term is legally defined according to the institution. It generally refers to recorded information regardless of form. Most institutions hold title to data while researchers have rights to access the data.
The process of handling the data gathered during a clinical trial. May also refer to the department responsible for managing data entry and database generation and/or maintenance.
Intentionally misleading or withholding information about nature of experiment.
Declaration of Helsinki
A series of guidelines adopted by the 18th World Medical Assembly in Helsinki, Finland in 1964. The Declaration addresses ethical issues for physicians conducting biomedical research involving human subjects. Recommendations include the procedures required to ensure subject safety in clinical trials, including informed consent and Ethics Committee reviews.
Refers to the characteristics of study participants, including sex, age, family medical history, and other characteristics relevant to the study in which they are enrolled.
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.
All forms of records that describe or document study methods, conduct and results, including any adverse events and actions taken.
As defined by the Food, Drug and Cosmetic Act, drugs are “articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals.”
Drug or Device Accountability Records (DAR)
Required documentation for material accountability, quantity used and left over, and date of disposal.
A finished dosage form (e.g. tablet, capsule, or solution) that contains the active drug ingredient usually combined with inactive ingredients.
The dose of an investigational agent that produces the outcome considered “effective,” as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms.
A product’s ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants.
Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
U.S. Food and Drug Administration
Federal Register (FR)
Publication of the federal government to establish new regulations or to change existing regulations.
Food and Drug Administration (FDA)
Within the Department of Health and Human Services. Enforces Food, Drug and Cosmetics Act and related federal public health laws. Grants IND, IDE, PMA and NDA approvals.
Food Drug and Cosmetic Act (FD & C Act )
States only drugs, biologics and devices proven safe and effective can be marketed.
Good Manufacturing Practices, also referred to as Quality System under 21 CFR 820
Good Clinical Practice (GCP)
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that subject’s rights and confidentiality are protected.
A patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction.
Humanitarian Device Exemption (HDE)
A premarket approval application submitted under 21 CFR 814 Subpart H seeking a humanitarian device exemption from the effectiveness requirements of sections 514 and 515 of the FD&C Act as authorized by section 520(m)(2) of the Act.
Humanitarian Use Device (HUD)
A medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.