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Biometrics - / VA method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - /VAn environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - /VAn 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, Sec. 11.3) Electronic Record - /VAny 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, Sec. 11.3) Electronic Signature - /VA computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten signature. (21.CFR, Sec. 11.3) Open system - /VAn environment in which system access is not controlled by persons who are ible forth tent-ef-the-electroni ds-that th +t 3 443} responsil rthecontent-of the electroni rds that-are-on the sy 5 Sees 44:3} Clinical Investigation - //Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is 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. (21 CFR, sec. 50.3) Investigator - /VAn 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, sec. 50.3) Sponsor - /VA 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 the individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (21 CFR, sec. 50.3) Sponsor-Investigator - / /An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3) Handwritten Signature - /VThe scripted name or legal mark of an individual handwritten by that individual. (21 CFR, Sec. 11.3) Legally Authorized Representative - /V An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved. (21 CFR, sec. 50.3) Family Member - //Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is equivalent of a family relationship. (21 CFR, sec. 50.3) Assent - /VA child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3) Children - / /Persons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3) Parent - V VA child's biological or adoptive parent. (21 CFR, sec. 50.3) Ward - VVA child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3) Permission - / /The agreement of the parent(s) or guardian to the participation of their child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart B and must include all the elements of the informed consent. (21 CFR, sec. 50.3) Guardian - /VAn individual who is authorized under applicable State or local law to consent on behalf Of a child to general medical care when general medical care inciudés research. (21 CFR, sec. 50.3) Implant - /VA 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. (21 CFR, sec. 812.3) Investigational Device - / VA device, including a transitional device that is the object of investigation. (21. CFR, sec. 812.3) Monitor - / When used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of and investigation. When used as a verb, means to oversee and investigation. (21 CFR, sec. 812.3) Noninvasive diagnostic device or procedure - / /One that does NOT 1) penetrate the skin or mucous membranes of the body, ocular cavity or the urethra 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. (21 CFR, sec. 812.3) Significant Risk Device - //An investigational device that 1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject 2) is purposed or represented to be for a use in supporting or sustaining human life and presents a potential serious risk 3) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (21 CFR, sec. 812.3) Termination - /VA discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Translational Device - VA device that FDA considered to be a new drug or and antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3) Adverse Drug Reaction (ADR) - YW All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) Adverse Event (AE) - // Any untoward medical occurrence ina patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) Applicable Regulatory Requirements - / /Any laws and regulations addressing the conduct of clinical trials of investigational products (ICH GCP E6 1.4) Audit - /VA systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP E6 1.6) Audit Certificate - /VA declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report - /V/A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8) Audit Trail - ¥ YDocumentation that allow reconstruction of the course of events. (ICH GCP E6 1.9) Blinding/Masking - / VA procedure in which one or more parties to the trial are kept unaware of the treatment assignment. (ICH GCP E6 1.10) Coordinating Investigator - //An investigator assigned the responsibility for the coordination of investogators at different centres participating in a multicentre trial. (ICH GCP E6 1.19) Contract Research Organization (CRO) - /VA person or an organization (commercial academic or otherwise) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20) Direct Access - /¥ Permission to examine, analyze, verify, and reproduce any records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6 1.21) Documentation - YWAIl records, in any form, that describe or record the methods, conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH GCP E6 1.22) Essential Documents - /¥Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH GCP E6 1.23) Good Clinical Practice (GCP) - / WA standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of the trial subjects are protected. (ICH GCP E6 1.24) Independent Data Monitoring Committee (IDMC) - / May be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints. (ICH GCP E6 1.25) LAR cannot read, and who reads the informaed consent for, and any other written information supplied to the subject. (ICH GCP E6 1.26) Independent Ethics Committee (IEC) - YWAn independent body (a review board or a committee, institutional, regional, national or supranational), constitutes fo medical professionals and non-medical 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 favourable opinion on, the trial protocol, the suitability of the investigators, facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH GCP E6 1.27) Inspection - //The act by a regulatory authority of conducting and official review of documents, facilities, records and any other resources that are deemed by the authorities to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6 1.29) Interim Clinical Trial/Study Report - /VA report of intermediate results and their evaluation based on analyses performed during the course of the trial. (ICH GCP E6 1.32) Investigational Product - /VA pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trail, including a product with a marketing authorization when used or assembled in a different way from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH GCP E6 1.33) Investigator's Brochure - VA compilation of the clinical and nonclinical data on the investigational products which is relevant to the study of the investigational products in human subjects. (ICH GCP E6 1.36) Randomization - /VThe 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 E6 1.48) Regulatory Authorities - “Bodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data. Form 1572 - / /Statement of investigator for IND Form 1571 - // Cover sheet for an IND application Private Information - VV - information about behavior which occurs in a context in which an individual can reasonably expect that no observation or recording is taking place - information which has been provided for a specified purpose by an individual and which the individual can reasonably expect will not be made public (e.g. medical record) IRB membership requirements according to 45 CFR 46 - /V- minimum of 5 members - IRB must be qualified through experience, expertise, diversity - diversity with respect to race, gender, cultural background - cannot consist of members of one profession - at least one member must have a primary concern ina scientific area and one ina non-scientific area - at least one member not affiliated with the institution 
