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| TrialMed India Clinical Trial Institute |
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Clinical Research Institute – An organization that train CRAs/CRC/PIs and health care professionals to conduct clinical research. The institute provides flexible on-line training and webinars to assist clinical research professionals to conduct clinical studies according to international, and FDA GCP guidelines.
Our training is customized to assist research professional to work with pharmaceutical, medical device and biologic clinical trials.
Please contact: Trialmed team (link) for more information on upcoming event.
Glossary of Terms
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Glossary
510(k): A 510(k) is a premarketing submission made to FDA to demon
strate that the device to be marketed is as safe and effective as, that is, substantially equivalent (SE) to, a legally marketed device that is not subject to premarket approval (PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device. FDA database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information are available via the web interface for more recent records. The database is updated monthly. (www.fda.gov/cdrh/databases.html)
513(g): A written formal request to the FDA for device classification.
Accelerated Aging: Refers to the process of exposing samples of a device and its packaging to elevated temperatures in order to simulate a longer period of real time aging over a shorter period of time.
Action letter: An official letter from the FDA to a Sponsor that informs of a decision by the agency on an application submittal. An approval letter indicates the product can be approved after minor issues are resolved. A non-approval letter describes significant deficiencies in the application that require correction before the application can be considered.
Active Medical Device: An active medical device' means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity (MDD 90/385/EEC).
Active Implantable Medical Device: An active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure (MDD 90/385/EEC).
Adverse Event: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a casual relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. (See ICH Guideline for Clinical Safety Data Management: definitions and Standards for Expedited Reporting) (ICH GCP).
Advisory Notice: A notice which provides information to concerned parties regarding medical devices (e.g. information regarding safety concerns).
Aeration: When used in connection with the ethylene oxide sterilization process the term aeration refers to the step in the process where the ethylene oxide gas is allowed to dissipate from the items that have been sterilized.
Antiseptic: A germicide used to destroy microorganisms on the skin.
AAMI: American Association of Medical Instrumentation.
Annual Report: A concise report of the progress of the investigation submitted by the sponsor to the FDA within 60 days of the anniversary date on which an Investigational Device Exemption (IDE) became effective (also called a Progress Report).
Applicable Regulatory Requirement(s): The law(s) and regulation(s) which are relevant to the conduct of a particular clinical trial, regulatory submission, or compliance issue.
Approval (in relation to Institutional Review Boards): The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. (ICH GCP)
Audit: A systematic and independent examination of trial-related activities, study data, protocol procedures, study conduct, and interim or final study reports to determine whether the evaluated trial-related activities were conducted, and the data was recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP) and the applicable regulatory requirements.
Audit Certificate: A declaration of confirmation by the auditor that an audit has taken place. (ICH GCP)
Audit Report: A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP)
Audit Trail: Documentation that allows reconstruction of the course of events. (ICH GCP)
Balloon Dilatation Catheter: A catheter that has a balloon near its distal end, which can be inserted into a vein or artery. The balloon can then be inflated in order to dilate that vein or artery.
Batch or Lot: One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. (21 CFR 820.3 (m))
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (FDA, Information Sheet).
Bioburden: Refers to the microbial load, i.e. the number of microorganisms, on an item to be sterilized.
Biologic: 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. (FDA)
Biological sterilization process indicator: (biological indicator): A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of a known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. (21 CFR §880.2800)
Biometrics: A method of verifying and individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. (21 CFR Part 11)
Bioresearch Monitoring (BIMO): A comprehensive Food and Drug Administration (FDA) program of on-site inspection and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research. The objectives of the Bioresearch Monitoring program include verification of the quality and integrity of the research data as well as protection of the rights and welfare of human research subjects.
Biostatistics: Statistics applied to the analysis of biological data.
Blinding/Masking: Characteristic of controlled study design in which one or more parties to the trial are dept unaware of the treatment assignment. Single-blind, patients do not know which treatment they receive. Double-blind, is when neither the patient nor the investigator know which treatment the patient receives.
Calibration: The process of periodically checking and adjusting measuring devices and instruments to ensure specified accuracy and precision that is traceable to national or international standards.
Case Report Form (CRF): A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH GCP)
Catheter: A device consisting of a flexible tube which is used to create an access to an area within the body in order to deliver a substance of to create a pathway for another device.
Center for Devices and Radiological Health: (CDRH) Branch of the FDA which protects the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposures to radiation emitted from electronic products.
Certificate of Analysis: Documentation from a supplier guaranteeing the content and quality of raw materials or components.
Change Control: The necessity of using established procedures for changes to raw materials, components, or processing procedures used in the manufacture of a regulated product. Such controls are used in order to make accurate and complete documentation of all aspects of the products being manufactured, and to avoid arbitrary changes to the product.
Chemical Germicide: A substance used to disinfect an item.
Class I Device: Class I devices are those subjected to the least regulatory control. Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or III devices. Class I devices are subject to “General Controls.” (CDRH)
Class II Device: Class II devices are those for which General Controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with General Controls, Class II devices are also subject to Special Controls. Special Controls may include special labeling requirements, guidance documents, mandatory performance standards and postmarket surveillance. Requires 510(k) unless exempted. May require clinical trials. (CDRH)
Class III Device: Class III devices are subjected to the most stringent regulatory control. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Devices classified into Class III are usually those which support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Requires PMA. (CDRH)
Class I Equipment: Equipment which reduces the risk of electrical shock by using basic insulation, and a connection of the equipment to the protective earth conductor in the fixed wiring.
Class II Equipment: Equipment which reduces the risk of electrical shock by using not only basic insulation but also double insulation or reinforced insulation as well.
Clinical Events Committee: A group of clinical and/or statistical experts responsible for reviewing adverse events occurring during a clinical trial and determining whether or not they were device-related or procedure-related.
Clinical Research Associate (CRA): A professional who, irrespective of job title, supervises, monitors, and supports the administration and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of pharmaceuticals, biologics or devices, may employ these individuals either directly or indirectly via Contract Research Organizations (CROs) or independent consultants/contractors. The CRA must be independent of the investigative staff conducting the research at the site or institution and should not be employed or supervised by the investigative site or the institution. (ACRP)
Clinical Research Coordinator (CRC): A CRC, regardless of job title, works at a clinical research site under the immediate direction of a principal investigator whose research activities are conducted under Good Clinical Practice (GCP) and ICH Guidelines. CRCs and other professionals referred to as research nurses, trial nurses, site coordinators, etc., perform tasks such as verifying study feasibility, facilitating formal approval, planning trial execution, assisting in subject recruitment, coordinating study procedures, collecting accurate and verifiable data, safeguarding GCP, protocol and investigational product compliance, communicating with the sponsor and regulatory authorities (including audits & inspections), and coordinating study close out. (ACRP)
Clinical Significance: A statistically significant improvement in a study subject’s condition during the course of a clinical trial. The improvement may or may not be device-related.
Clinical Trial/Study: Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s) and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous. (ICH)
Closed System: An environment in which system access is controlled by persons who are responsible for the content of electric records that are on the system. (21 CFR 11.3 (b) (4))
Code of Federal Regulations (CFR): The Code of Federal Regulations (CFR) is a codification of general and permanent rules (regulations) that have been previously published in the Federal Register. The CFR, which is compiled by the Office of the Federal Register, is divided into 50 titles, which cover broad areas subject to Federal regulation. Title 21 of the CFR comprises the regulations dealing with Food and Drugs.
Cohort: A group of subjects participating in a clinical study followed at regular, predetermined intervals; a subset on the eligible study population.
Colony Forming Unit: (CFU) Visible growth of microorganisms arising from a single cell or multiple cells.
Combination Product: 1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; 2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; 3) A drug, device or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device or biological product where both are required to achieve the intended use, indication or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration or significant change in dose; or 4) Any investigational drug, device or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device or biological product where both are required to achieve the intended use, indication or effect. (21 CFR 3.2 (e))
Competent Authority (CA): The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.
Complaint: Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. (21 CFR 820.3 (b))
Compliance (in relation to clinical trial): Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. (ICH GCP)
Component: Any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device. (21 CFR 820.3 (c))
Conditioning: Treatment of the product during a sterilization cycle, in order to achieve a specified temperature and humidity throughout the sterilization load. This is done prior to the injection of the sterilant.
Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH GCP)
Contamination: The presence of any substance in a product that makes it impure, unclean, or unfit for use. There are three types of contamination: microbial, particulate, and cross-contamination.
Contract: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. (ICH, GCP)
Coordinating Committee: A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. (ICH GCP)
Coordinating Investigator: An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenters trial. (ICH GCP)
Contract Research Organization (CRO): A person or an organization contracted by the sponsor to perform some or all of the responsibilities related to the conduct of a clinical study.
Control Group: A group of patients receiving the standard treatment or placebo used for comparison to results obtained in the “treatment group,” the group of patients undergoing the experimental treatment regimen.
Control Number: Any distinctive symbols, such as a distinctive combination of letters, numbers, or both, from which the history of manufacturing, packaging, labeling, and distribution of a unit, lot, or batch or finished devices can be determined. (21CFR 820.3 (d))
Corrective Action: Action taken to eliminate the causes of an existing nonconformity, defect, or other undesirable situation in order to prevent recurrence.
Crossover trial: In crossover trials, each subject receives both treatments being compared or the treatment and control. Such trials are used for patients who have a stable, usually chronic, condition during both treatment periods.
Current Good Manufacturing Practice (CGMP) Requirements: The requirements that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. (21 CFR Part 820)
Current Density: The amount of current flowing through a given area divided by that area, expressed in amperes per meter.
Curriculum Vitae (CV): A document summarizing an investigator’s training and expertise, similar to a resume.
Custom Device: A device that 1) necessarily deviates from devices generally available, or from an applicable performance standard or premarket approval requirement, in order to comply with the order of an individual physician or dentist; 2) is not generally available to, or generally used by, other physicians or dentists; 3) is not generally available in finished form for purchase or for dispensing upon prescription; 4) is not offered for commercial distribution through labeling or advertising; and 5) is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice. (21 CFR 812.3 (b))
Data: 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.
>Data Safety Monitoring Board (DSMB): A group of experts, established by the study sponsor, to assess at intervals the safety data and the critical efficacy endpoints of a clinical study, and to recommend to the sponsor whether to continue, modify or stop a study.
Data Clarification Form (DCF): A form completed by the data reviewer or monitor and given to the study coordinator to obtain clarification or corrections to study subject case report forms. Also referred to as data query form and external clarification form.
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 subjects’ safety in clinical trials, including informed consent and Ethics Committee reviews.
Decontamination: According to the Occupational Safety and Health Administration (OSHA), “the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infections particles and the surface or item is rendered safe for handling, use or disposal.” (29 CFR 1910.1030)
Design History File (DHF): A compilation of records which describes the design history of a finished device. (21 CFR 820.3 (e))
Design input: The physical and performance requirements of a device that are used as a basis for device design. (21 CFR 820.3 (f))
Design output: The result of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of a device, its packaging, labeling, and the device master record. (21 CFR 820.3 (g))
Design review: A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capabilities of the design to meet these requirements, and to identify problems. (21 CFR 820.3 (h))
Design Validation: Establishing by objective evidence that device specifications conform with user needs and intended use(s). (See process validation) (21 CFR 820.3 (2))
Device History Record (DHR): A compilation of records containing the production history of a finished device. (21 CFR 820.3 (i))
Device Master Record (DMR): A compilation of records containing the procedures and specifications for a finished device. (21 CFR 820.3 (j))
Deviation: Reports on an event that has already occurred and is not in compliance with the protocol.
Device: See Medical Device.
DHHS: Department of Health and Human Services.
Digital Signature: An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR 11.3 (b) (5))
Direct Access: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. (ICH GCP)
Disinfection: A process whereby microorganisms are destroyed by subjecting them to high temperatures or chemical agents. However disinfection of a product does not render a product sterile.
Dispersive Electrode: In electrical stimulation therapy it is also known as the return electrode, which is used in conjunction with an active electrode. It also refers to the return, or patient grounding plate used during electrosurgical procedures.
Distribution Cycle: A description of the environments and hazards a product will be exposed to during its distribution such as shipping and storage.
Division of Small Manufacturers Assistance (DSMA): An arm of the CDRH whose mission is to aid the small manufacturer and other domestic and foreign producers of medical devices and radiation-emitting electronic products in complying with the law and to clarify the requirements of medical device regulations. (GMP Institute)
Documentation: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. (ICH GCP)
Double Blind: TThe design of an investigational study in which neither the investigator nor the subject knows which treatment the subject receives.
Effectiveness: The desired measure of a drug’s influence on a disease condition as proved by substantial evidences from adequate and well controlled investigators.
Efficacy: 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.
Electrocautery: A procedure that involves transmitting electrical current through a device that converts the current into heat which is then applied to tissue for the purpose of searing or destroying the tissue.
Electrode: A Device that is used to create an electrical connection between a patient and the output of an electrical power source such as a transcutaneous electrical nerve stimulator (TENS), a neuromuscular electrical stimulator (NMES), or an electrosurgical generator.
Electromagnetic Capability (EMC): A device is compatible with (i.e., no interference is caused by) its electromagnetic (EM) environment and it does not emit levels of EM energy that cause electromagnetic interference (EMI) in other devices in the vicinity. A medical device can be vulnerable to EMI if the levels of EM energy in its environment exceed the EM immunity (resistance) to which the device was designed and tested. (CDRH)
Electromagnetic Interference (EMI): Degradation of the performance of a piece of equipment, transmission channel or system (e.g., medical devices) caused by an electromagnetic disturbance. (CDRH)
Electromagnetic Susceptibility: The degree to which a device is vulnerable to disruption by the electromagnetic emissions generated by other electronic devices used within its environment.
Electronic Record: Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. (21 CFR 11.3 (b) (6))
Electronic Signature: A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. (21 CFR 11.3 (b) (7))
Electrostatic Discharge (ESD): A transfer of an electric charge between bodies that have different electrostatic potentials that occurs when they are brought into proximity or direct contact with each other.
Electrosurgery: The cutting and/or coagulation of tissue by use of high-frequency electrical current.
Electrosurgical Accessory: Those devices which are used in conjunction with the electrosurgical generator to accomplish electrosurgery.
Emergency Use: The use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval. (21 CFR 56.102 (d))
EN 540: European standard document, “Clinical Investigation of Medical Devices for Human Subjects,” with which product manufacturers have to comply in order to perform clinical trials in Europe.
Endotoxin: The lipopolysaccharide complex associated with the outer envelope of Gram-negative bacteria. Endotoxins are pyrogenic and may cause fever, shock and death when present in or on medical products introduced into humans.
Endpoint: A predetermined outcome in a clinical trial that shows a definitive result in a patient’s state of disease.
Essential Documents: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH GCP)
Establish: Define, document (in writing or electronically), and implement. (21 CFR 820.3 (k))
Establishment Inspection Report (EIR): The FDA investigator’s notes from surveillance and follow up inspections, which are filed with the District Office.
Ethics Committee (EC): A group, consisting of both medical and non-medical members, that is responsible for the safety of the subjects participating in a clinical investigation.
Ethylene Oxide Sterilization: Sterilization process that is commonly used for medical devices which utilizes ethylene oxide (EtO). EtO is a colorless gas with an ether-like odor.
Exclusion Criteria: Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
Exposure Time: The duration that a sterilizer chamber is maintained at specified conditions in order to sterilize product.
FDA Form 482: FDA written notice of inspection presented by the investigator at the beginning of an inspection.
FDA Form 483: A summary report of an FDA inspector’s observation. This is a list of objectionable conditions or practices observed during the inspection prepared by the FDA investigator and presented to the entity being audited at the conclusion of an inspection.
FMEA: Failure Mode and Effects Analysis . A risk analysis tool that operates by questioning what effect a particular action would have on the output of a system.
Final Study Report: A complete and comprehensive description of the completed study including, descriptions of experimental materials and methods, presentation and evaluation of the results, statistical analyses, and a critical discussion of the results.
Final Report (by the Investigator): A required summary (according to the specifications of an institution’s IRB) of the clinical study by the investigator to be submitted to the institution’s IRB and also the study sponsor.
Finished device: Any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. (21 CFR 820.3 (l))
Food and Drug Administration (FDA): An agency within the department of Health and Human Services. Enforces Food, Drug and Cosmetic Act and related federal public laws. Grants Investigational New Drug (IND), Premarket Approval Application (PMA) and New Drug Application (NDA) approvals.
Freedom of Information Act (FOIA): Act passed in U.S. in 1966 which permits public access to certain information in government files, including information regarding clinical trials.
Good Clinical Practice (GCP): Specific regulations and guidelines for the U.S. which identifies the responsibilities of sponsors, investigators, monitors, and IRB’s involved with clinical trials. The function is: 1) to ensure the protection and welfare of the clinical trial subjects; and 2) to ensure the quality and integrity of the clinical data collected.
Good Laboratory Practices (GLP): Nonclinical laboratory studies that support or are intended to support applications for research or marketing permits.
Good Manufacturing Practices (GMP): The part of the quality assurance which ensures products are consistently produced and controlled to quality standards appropriate for their intended use and as required by product specification. (See also Quality System Regulation)
Handwritten Signature: The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. (21 CFR 11.3 (b) (8))
Harm: Physical injury and/or damage to health or property.
Hazard: A potential source of harm.
Hazard Analysis: Identification of hazards and their causes.
Hazard Control: A design feature of a device or system intended to prevent an unacceptable hazard.
Health Care Facility: Hospital, nursing home, extended care facility, surgical center, clinic, medical office, or dental office.
High-Frequency (HF) Surgical Equipment: Electrical medical equipment and accessories which utilize high frequency electrical currents to perform surgical functions, such as cutting or coagulation of tissue.
Historical Control: Control group selected from data previously collected.
Human Subject: 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))
Hypothesis: An assumption not proved by experiment or observation. It is assumed for the sake of testing its soundness or to facilitate investigation of a class of phenomena.
Hypothesis Testing: A term used generally to refer to testing significance when specific alternatives to the null hypothesis are considered. A scientific method which begins with the statement of a null and an alternate hypothesis, the choice of the level of statistical significance (critical region), computation of the statistic, and conclusion (rejection of the null hypothesis) if the value of the test statistic falls in the critical region.
Implant: A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also “implants” for purposes of this part. (21 CFR 812.3 (d))
Immunity (to a disturbance): See electromagnetic susceptibility.
Independent Ethics Committee (IEC): An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and non-medical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guidance. (ICH GCP)
Inclusion Criteria: A list of criteria that must be met by all prospective study subjects as outlined in the study protocol.
Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. (ICH GCP)
Institution (medical): Any public or private entity or agency or medical or dental facility where clinical trials are conducted.(ICH GCP)
Institutional Review Board (IRB): Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. (21 CFR 50.3 (i))
Internal Quality Audits: Self audit by a company. This audit looks for ways to make the quality system work better, and tries to catch problems before a customer or registrar does. Audits are generally conducted at least once per year. (What every employee needs to know about ISO 9000)
International Conference on Harmonization (ICH): A set of international guidelines developed by the International Conference on Harmonization to regulate the conduct of clinical trials and assure they operate in compliance with GCP.
Intravascular Catheter: Tubular device designed to be inserted into the cardiovascular system (see also Catheter).
Investigation: A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. (21 CFR 812.3 (h))
Investigator: An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21 CFR 812.3 (i))
Investigator Brochure: A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. (ICH GCP)
Investigational Device: A device including a transitional device that is the object of an investigation. (21 CFR 812.3 (g))
Investigational Device Exemption (IDE): The document through which a sponsor requests approval from the FDA to investigate a device in human clinical trials. An approved IDE permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. (21 CFR 812.1)
Investigational New Drug (IND): The petition through which a drug sponsor requests the FDA to allow human testing of its drug product.
Investigational Plan: A detailed document describing the plan to conduct a study of the investigational product(s) in human subjects. The plan may include purpose, protocol, risk analysis, description of the investigational (s), monitoring procedures, labeling, consent materials, IRB information, investigator brochure, other institutions and additional records and reports.
Investigational Product: A Pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approval use. (ICH GCP)
In-vitro: “In glass” as in a test tube.
In Vitro Diagnostic Device: Reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. These products are intended for use in the collection, preparation, and examination of specimens taken from the human body. (21 CFR 809.3(a))
In Vitro Diagnostic Medical Devices Directive (IVDD): Abbreviation for, European Communities Council Directive concerning in vitro diagnostic medical devices. This information was published in the Official Journal of the European Communities on December 7, 1998.
In Vitro Testing: Non-clinical testing typically conducted in a test tube or culture medium.
In Vivo: In the living body.
In-Vivo Testing): Testing conducted in the living body - human or animal.
ISO 9001: A standard that specifies requirements for a quality management system that can be used for internal application by organizations, or for certification or contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements. (ISO 9001:2000)
ISO 9004: Gives guidance on a wider range of objectives of a quality management system than does 9001, particularly for the continual improvement of an organization’s overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, but is not intended for certification or contractual purposes. (ISO 9001:2000)
Label: All written, printed or graphic matter on a medical device, its containers, or wrappers.
Labeling (device): All written, printed, or graphic matter accompanying a product and approved by regulatory agencies as well as that which is attached to the device or its containers (e.g., instructions for use).
Lead: An insulated electrical wire, used to transfer energy along its length.
Lot or batch: One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. (21 CFR 820.3 (m))
Management with Executive Responsibility: Those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system. (21 CFR 820.3 (n))
Manufacturer: Any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repackaging, or specification development, and initial distributor of foreign entities performing these functions. (21 CFR 820.3 (o))
Manufacturing Lot: A group of products which are identifiable by the unit of time and/or quantity in which they were produced.
Manufacturing Material: Any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer. (21 CFR 820.3 (p))
Marking: Refers to any inscription or symbol placed on a device.
Medical Device: Any instrument, apparatus, or other similar or related article, including component, part, or accessory, which is: (a) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans or other animals; or (c) intended to affect the structure or any function of the human body or in animals; and does not achieve any of its principal intended purposes through chemical action within or on the human body or in animals and is not dependent upon being metabolized for the achievement of its principal intended purposes. (FDA, fda.gov/oc/gcp/guidance.html)
Medical Devices Directive (MDD): European Communities Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as published in the Official Journal of the European Communities on July 12, 1993.
Medical Device Report (MDR): A report required by FDA regulation. An event requiring an MDR is one that reasonably suggests that a Company product may have caused or contributed to death or serious injury or has malfunctioned in a way that may likely cause death or serious injury if the malfunction were to recur . The FDA has a specific definition of what constitutes a serious injury for medical device reporting purposes. (21 CFR 803)
Medical Monitor: An individual at the Sponsor Company, or contract research organization, usually a physician, who is responsible for the clinical development of a product and the conduct and progress of a clinical trial(s).
Medicinal Substance: Substance which is used for the treatment or prevention of disease.
Microbial Barrier: This term is often used to refer to a sterile medical device package’s ability to prevent the ingress of microorganisms.
Monitor: An individual designated by a sponsor or contract research organization to oversee the progress of an investigation. The monitor may be an employee of a sponsor or a consultant to the sponsor, or an employee of or consultant to a contract research organization. (21 CFR 812.3 (j))
Monitoring: The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOP’S), good clinical practice (GCP), and the applicable regulatory requirement(s). (ICH GCP)
Monitoring Report: A written report from the monitor to the sponsor after each site Visit and /or other related communication according to the sponsor’s SOP’s. (ICH GCP)
Multi-center Trial: A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH GCP)
National Institute of Health (NIH): A federated agency within the public health service, DHHS, comprised of 27 institutes and centers, the focal point of medical research within the U.S.. It is responsible for supporting biomedical and behavioral research.
New Drug Application (NDA): A regulatory submission to the FDA requesting approval to market a new drug in the U.S. for human use.
Nonclinical Study: Biomedical studies not performed on human subjects. (ICH GCP)
Nonconforming Material: Material which does not meet its established specifications.
Nonconformity: The nonfulfillment of a specified requirement. (21 CFR 820.3 (q))
Noninvasive: When applied to a diagnostic device or procedure, means one that by design or intention: 1) Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra, or 2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os. For purposes of this part blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes is also considered noninvasive. (21 CFR 812.3 (k))
Non-Significant Risk Device: An investigational device that does not present significant risk to the patient. (See also Significant Risk Device)
Notified Body: A private institution charged by the Competent Authority with verifying compliance with the applicable Essential Requirements stated in the Medical Device Directive. This process called Conformity Assessment has EU-wide validity once completed by the Notified Body.
Nuremberg Code: Code of ethics for conducting medical research established by the Nuremberg tribunal in 1947. This code is designed to protect the safety and integrity of study participants.
Open Label Study: A study in which all parties, (patient, physician and study coordinator) are informed of the drug and dose being administered. In an open -label study, none of the participants are given placebos. These are usually conducted with Phase I and II studies.
Open System: An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR 11.3 (b) (9))
OHRP: Office for Human Research Protection.
OSHA: Occupational Safety and Health Administration.
OUS: Outside the United States.
Package Shelf Life: The amount of real time (not accelerated time) that a package can be in storage at ambient, or specified conditions, and still retain its critical performance properties.
Parametric Release: Declaring product as sterile, based on physical and/or chemical process data rather than on the basis of sample testing or biological indicator results. (ISO 11135:1994, 3.13)
Pediatric or Child: Individuals that are from 29 days to 18 years in age.
Phase I Study: The first trials in humans that test a compound for safety tolerance and pharmacokinetics. The trials usually employ normal, healthy volunteers.
Phase II Study: After the successful completion of phase I trials, these studies (for drugs) are performed to define efficacy in selected populations of patients with the disease or condition to be treated, diagnosed, or prevented. They are usually randomized, tightly controlled studies using a relatively small number of carefully selected patients.
Phase III Study: The third and last pre-approval round of testing of a drug. Expanded clinical trials are performed in large numbers of patients to gather additional evidence of effectiveness for specific indications and to better understand safety and drug related adverse effects.
Phase IV Study: Studies performed after a drug is approved for marketing. The studies are performed to determine the incidence of adverse reactions; to determine the long-term effect of a drug; to study a patient population not previously studied; and/or for marketing comparisons against other products and other uses.
Pilot Study: A study conducted in a small number of subjects to determine the feasibility of pursuing larger-scale clinical development of a product. Also referred to as a “feasibility study” or ” phase I study”.
Placebo: A pharmaceutical preparation that contains no active agent. In blinded studies it is generally made to look just like the active product.
Post Market Studies: Studies conducted after the device has been approved for marketing. The purpose of these studies includes comparing the product to a competitor, exploring use in additional subject populations, or exploring adverse experiences.
Post-marketing Surveillance: Sponsor’s monitoring of the use of a device or drug in the general population after marketing to evaluate adverse events.
Pre-Clinical: Laboratory and animal studies designed to test the mechanisms, safety, and efficacy of an intervention prior to its applications to humans. (IRB Glossary)
Preconditioning: Term that when used in connection with sterilization refers to the treatment of product before the sterilization cycle has begun in order to achieve a predetermined temperature and humidity throughout the sterilization load.
Pre Market Approval (PMA): Any premarket approval application for a class III medical device, including all information submitted with or incorporated by reference therein. PMA includes a new drug application for a device under section 520(l) of the act. (21 CFR 814.3 (e))
PMA Amendment: Information an applicant submits to the 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 information submitted with or incorporated by reference therein. (21 CFR 814.3 (g))
Predicate Device: Currently legally marketed devices to which new devices may be found substantially equivalent under the FDA’s 510(k) process for seeking market clearance.
Preventive Action: Action taken to eliminate the causes of a potential nonconformity, defect, or other undesirable situation in order to prevent occurrence.
Primary Manufacturer: The company that is responsible for the fabrication, performance and safety of a medical device.
Process Challenge Device: A device which represents the worst-case scenario for a sterilization process. It is used to test the effectiveness of a particular sterilization process.
Process Validation: Establishing by evidence that a process consistently produces a result or product meeting its predetermined specifications. (See also Design Validation and Validation) (21CFR 820.3 (1))
Product: According to the quality system regulation use of this term, it refers to components, manufacturing materials, in-process devices, finished devices, and returned devices. (21 CFR 820.3 (r))
Product Seizure: An FDA action to remove a product, which is in violation of FDA regulations, from the market by requesting a court to direct a U.S. Marshal.
Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. (ICH GCP)
Protocol Amendment: A written description of a change(s) to or formal clarification of a protocol. (ICH GCP)
Primary Endpoint: An endpoint that is analyzed with the intent to answer the main objective and hypothesis of the study.
Prospective: Investigation in which a group of subjects is recruited and provided a therapy or treatment and monitored in accordance with the criteria in a protocol.
Pyrogen: An agent that causes a rise in temperature -- fever. Pyrogens are produced by bacteria, molds, viruses, and yeasts.
Quality: The totality of features and characteristics that bear on the ability of a device to satisfy fitness for use, including safety and performance. (21 CFR 820.3 (s))
Quality Assurance (QA): All planned and systematic actions implemented within the quality system and demonstrated as needed to provide adequate confidence that a product or service will fulfill requirements for quality.
Quality Audit: A systematic and independent examination of a quality system that is performed at defined intervals and at sufficient frequency to determine whether both the quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. (21 CFR 820.3 (t))
Quality Control (QC): The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. (ICH GCP)
Quality Cost: An analysis of costs involved in maintaining quality in the following areas: preventive, appraisal, and failure costs.
Quality Manual: Documentation that describes a company’s structure, its approach to meeting the customer’s needs, its documentation structure, and the policy and responsibilities of management for meeting the requirements of the standards. (What every employee needs to know about ISO 9000)
Quality Policy: The overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility. (21 CFR 820.3 (u))
Quality Procedures: Describe the steps each person or department must follow to meet the policies described in the quality manual. Procedures specify who does what, when (and possibly were) it is done, and what documentation is used or produced as a result of the activity. (What every employee needs to know about ISO 9000)
Quality Records: Provides evidence that the required product or service quality was achieved, or that the company’s quality system was implemented. (What every employee needs to know about ISO 9000)
Quality System: The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. (21 CFR 820.3 (v))
Quality System Regulation: The regulations that embody the good manufacturing and documentation requirements for the design and manufacture of medical devices. (21 CFR 820 )
Quality Work Instructions: Specific Instructions for accomplishing certain tasks that are referenced in broader procedures.
Radioactive Substance: Any substance with one or more nuclides.
Randomization: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH GCP)
Real-Time Aging: Storage time of samples at ambient conditions as opposed to accelerated aging.
Real-Time Equivalent: Refers to the amount of real-time that the accelerated aging conditions approximate.
Recall: A firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action (e.g., seizure). A recall does not include a market withdrawal or a stock recovery. (21 CFR 7.3 (g))
Recruitment (Subjects): The process that employs inclusion and exclusion criteria and is used by investigators to enroll appropriate subjects into a clinical trial.
Reference Load: A load of products to be sterilized that represents the most difficult combination of products that a particular sterilization process will encounter.
Registrar: A company that will audit another company’s quality system to see if it is meeting the requirements of the ISO 9000 standards.
Regulatory Affairs: The department within a regulated industry that involves compliance with government regulations and interaction with government agencies.
Regulatory Authorities: Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities. (ICH GCP)
Remanufacturer: Any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. (21 CFR 820.3 (w))
Reusable Medical Device: A device which is designed to be used more than once and on different patients.
Rework: Any action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution. (21 CFR 820.3 (x))
Risk: The probability that a particular hazard that could cause harm will occur and the level harm it would cause.
Risk Analysis: The study of available information to identify hazards and to estimate risks.
Safe Medical Devices Act (SMDA): Was enacted in 1990 and gave the FDA broader authority over the medical device industry particularly in the areas of premarket notification and post marketing requirements.
Safety: Freedom of unacceptable risk of harm. Also relevant is: The devices must be designed and manufactured in such a way that, when used under the conditions and for the purpose as intended by the manufacturer, they will not compromise the clinical condition or the safety of the patients, or the safety and health of users or, where applicable, other persons, provided that any risk which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are comparable with a high level of protection of health and safety. (Annex I.1 MDD)
Safety Alert or Notification: Means a public notification providing information important to the safe or effective use of a medical device. This action does not require removal from the field or modification of distributed product.
Sanitization: The process of reducing the level bacterial contaminants in an environment to a relatively safe level.
Seal: Result of joining of surfaces together.
Seal Integrity: This term, when used in conjunction with medical devices, usually refers to the characteristics of the device’s package seal that ensures it creates a microbial barrier.
Seal Strength: Refers to the mechanical strength of the seal.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction: Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH GCP)
Serious Injury: When used in regard to regulatory compliance, particularly Medical Device Reporting, this term refers to an injury or illness that is: life threatening; results in permanent impairment of a body function or permanent damage to body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, where “permanent” means irreversible impairment or damage to a body structure or function excluding trivial impairment or damage. (21 CFR 803.3 (bb) (1) and (2))
Shipping Unit: Refers to the smallest unit of product that will undergo the distribution environment. This term is often used in conjunction with simulated distribution testing.
Single Blind Study: A study in which the subjects do not know whether they are receiving the active medication/treatment or a placebo/control device.
Significant Risk Device: An investigational device that presents a potential for serious risk to the health, safety, or welfare of a subject and: 1) is intended as an implant; 2) is purported or represented to be for a use in supporting or sustaining human life; or 3) is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. (21 CFR 812.3 (m))
Site Visit: A visit to a study site by a monitor for the purpose of reviewing case report forms against source documentation and to ensure the center is complying with the requirements of the study protocol.
Software Validation: Establishment by objective evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements.
Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). (ICH GCP)
Source Documents: Original documents, data, and records which include hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial. (ICH GCP)
Specification: Any requirement with which a product, process, service, or other activity must conform. (21 CFR 820.3 (y))
Splashproof Equipment: Equipment that is enclosed in such a way so as to prevent any liquid that may be splashed on it from entering the equipment or interfering with its operation.
Sponsor: A person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor. (21 CFR 50.3 (e))
Sponsor-Investigator: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. (ICH GCP)
Standard Deviation: (statistics) Indicator of relative variability of a variable around it’s mean; the square root of the variance.
Standard Operating Procedure (SOP): Detailed, written instructions to achieve uniformity of the performance of a specific function.(ICH GCP)
Statistical Significance: Level at which an investigator can conclude that observed differences are due to chance alone; for example, a p value of .05 (also called significance at the .05 level) indicates that there is about 1 chance in 20 that the differences observed occurred by chance alone.
Steam Sterilization: A sterilization process that uses pressurized steam for a specific length of time and at a specific temperature.
Sterilant Injection Stage: The point in time during a sterilization cycle where the sterilant is injected into the chamber.
Sterile: The condition of being free of viable microorganisms..
Sterility Assurance Level: The probability that any microorganisms will survive a sterilization process. It is used as an indication of the effectiveness of a particular sterilization process.
Sterilized Load: A group of products which have been sterilized at the same time and in the same sterilization chamber.
Study Coordinator: (See Clinical Research Coordinator)
Sub-Investigator: Any individual member of the clinical team designated and supervised by the investigator at a trial site to perform critical trial -related procedures and /or to make important trial-related decisions (e.g., associates, residents, research fellows). (ICH GCP)
Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (ICH GCP)
Subject Identification Code: A unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subject’s name when the investigator reports adverse events and /or other related data. (ICH GCP)
Supplement: A submission by a sponsor to the FDA for changes to an approved device, its manufacturing process or certain elements of its labeling.
Termination: Discontinuance of an investigation before completion by sponsor or by withdrawal of IRB or FDA approval.
Terminally Sterilized: Devices that have undergone a sterilization process.
Test Article: Any drug (including a 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 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n). (21 CFR 50.3 (j))
Test Method Validation: Establishing by objective evidence that a test method consistently produces a result meeting its predetermined specifications.
Third-Party Quality Audits: Audits by a registrar. The audit determines whether the company should become (or stay) registered to ISO 9000. Audits are typically conducted every six to nine months once a company has passed the registration audit.
Traceability: The ability to trace the history, application, or location of an item or activity and like items of activities by means of recorded identification.
Treatment Group: Study subjects randomized in a controlled clinical trial who receive the investigational device or drug therapy.
Trial Master File: A hard copy of all documentation relating to a clinical trial.
Trial site: The location(s) where trial-related activities are actually located. (ICH GCP))
Triple- Blind Study: A study in which knowledge of the treatment is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.
Unacceptable Hazard: A potential harm that, when its degree and probability of occurrence are considered, outweighs the potential benefit associated with it.
Unanticipated Adverse Device Event: Any serious adverse effect on health or safety or 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 investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subject. (21CFR 812.3 (s)))
Validation: Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. (21 CFR 820.3 (z))
Verification: To confirm by examination and provision of objective evidence that specified requirements have been fulfilled. (21 CFR 820.3 (a))
Vigilance: A European Economic Community (EEC) regulation for manufacturers of CE marked products to report certain events to a Competent Authority. Similar to US MDR Regulation, but different reporting criteria applies. A Vigilance event is one that occurs in the EEC, and those events which occur outside the EEC which result in systematic field Corrective Action involving product placed on the market or put into service in the EEC.
Voltage Surge: A transient voltage wave which increases rapidly and decreases more slowly.
Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. (ICH GCP)
Well-being (of trial subjects): The physical and mental integrity of the subjects participating in a clinical trial. (ICH GCP)
Work Instructions: Documents that describe in detail the step-by-step requirements to perform a specific quality system function or activity.
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