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Biometrics A 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 An 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 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, Sec. 11.3) 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, Sec. 11.3) Electronic Signature A 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 An environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system. (21 CFR, Sec. 11.3) 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 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, sec. 50.3) 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 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) Responsibilities:
- Selecting experienced and qualified investigators and sites to carry out the clinical trial
- Developing a monitoring plan for study investigator sites
- Complying with applicable U.S. and international regulations and guidelines
- Providing each site with the protocol, Investigator's Brochure (IB), and other essential documents
- Providing investigational product and supplies to all study sites
- Informing the FDA, other regulatory authorities, IRBs, and participating investigators of all serious adverse events (SAEs), unanticipated problems, and significant safety reports
- Establishing and operating a Data Monitoring Committee (DMC), if one is warranted, to monitor the clinical outcome of an ongoing trial 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 The scripted name or legal mark of an individual handwritten by that individual. ( CFR, Sec. 11.3) Act The Food, Drug and Cosmetic Act, as amended. 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, sec. 50.3) Institution Any public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3) 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. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act. (21 CFR, sec. 50.3)
Test Article Any food or 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 Services Act. (21 CFR, sec. 50.3) Minimal Risk Means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in
A review panel the is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. ( CFR, sec. 312.3) Custom Device A device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient. ( CFR, sec. 812.3) 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. (21 CFR, sec. 812.3) Investigational Device A 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 A discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Translational Device A device that FDA considered to be a new drug or and antibiotic drug before May 28,
- (21 CFR, sec. 812.3) Unanticipated Adverse Device Event Any serious adverse effect on the health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect or problem, or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application. (21 CFR, sec. 812.3) Department of Agency Head The head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. (45 CFR, sec. 46.102) Legally Authorized Representative (LAR)
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 in the research. (45 CFR, sec. 46.102) Viable As it pertains to the neonate, means being able after delivery to survive. Human Subject A living individual about whom an investigator conducting research obtains 1)Data through intervention or interaction with the individual 2) Identifiable private information. (45 CFR, sec. 46.102) Certification The official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102) Adverse Drug Reaction (ADR) 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 in a 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 A 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 A declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E 1.8) Audit Trail Documentation that allow reconstruction of the course of events. (ICH GCP E6 1.9) Blinding/Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment. (ICH GCP E6 1.10) 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 E6 1.11) Clinical Trial/Study Report A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (ICH GCP E 1.13) Comparator (Product)
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 E 1.29) Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analyses performed during the course of the trial. (ICH GCP E6 1.32) Investigational Product A 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 A 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) Legally Acceptable Representative An individual or juridicial or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subjects participation in the clinical trial. (ICH GCP E6 1.37) Monitoring Report A written report from the monitor or sponsor after each site visit and/or other trial- related communication according to the sponsor's SOPs. (ICH GCP E6 1.39) Multicentre 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 E6 1.40) Nonclinical Study Biomedical studies not performed on human subjects. (ICH GCP E6 1.41) Protocol Amendment A written description of changes to or formal clarification of a protocol. (ICH GCP E 1.45) Quality Assurance (QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with Good Clinical Practices and the applicable regulatory requirements. (ICH GCP E6 1.46) 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 E6 1.47) 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 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
- Investigator agreement to conduct study in compliance with FDA Form 1571 Cover sheet for an IND application Private Information
- 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
- 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 in a scientific area and one in a non-scientific area
- at least one member not affiliated with the institution Circumstances/conditions required for informed consent
- subject has had sufficient opportunity to consider whether to participate
- the possibility of coercion or undue influence is minimized Informed Consent MUST Contain:
- explanation of purpose of research
- duration of participation
- description of procedures to be followed
- identification of any procedures which are experimental
- any foreseeable risks or discomfort
- statement about potential benefits to subjects
- statement if no reasonable alternative procedures or treatments are available to subjects
- for > minimal risk, a statement about compensation and if medical treatment is available for injuries
- statement of who to contact in the event of research-related injury Informed Consent ADDITIONAL Elements:
- risk to embyro or fetus
- termination procedures
- costs to study subjects
- approximate number of study subjects
- a statement of new findings when they may impact a subject's willingness to participate Oral consent
When it fits all SAE criteria but is not life-threatening and does not result in death. 21 CFR 50 Protection of Human Subjets/Informed Consent 21 CFR 11 Electronic Records/Signatures Where would you look to find official government information regarding GCP? US Code of Federal Regulations According to ICH guidelines, how many members should an IRB have? at least 5 How many calendar days does a sponsor have to report a fatal or life-threatening unexpected adverse drug reaction? 7 calendar days According to ICH guidelines, IRB must retain records for... 3 years Phase I Clinical Trial Small trials with healthy subjects, purpose is to determine pharmacokinetics and maximum tolerated dose 21 CFR 56 IRB 45 CFR (Part A) The Common Rule - the regulations governing the IRB (not including the FDA) 45 CFR Part B Pregnant Women and Fetuses 45 CFR Part C Prisoners 45 CFR Part D Children 45 CFR Part E IRBs Phase II Clinical Trial Initial demonstration of efficacy in patients, short-term safety information Phase III Clinical Trial Use in large numbers of patients, long-term safety Phase IV Clinical Trial Post-marketing, continue assessing therapeutic value and monitor less common adverse events Are devices intended solely for veterinary use exempt form IDE regulations? Yes According to GCP guidelines, does the term vulnerable subject also include employees under direct supervision of clinical investigator? Yes Nuremberg Code 1947 Declaration of Helsinki 1964 Belmont Report 1979 Publication of FDA Regulations 1980 HHS and FDA Revise Regulations
Publication of Common Rule 1991 GCP and HIPAA 1996 OHRP 2000 What was the purpose of the Nuremberg Code protect human subjects following the Nuremberg trials in which WWII Nazis were tried for human experimentation What was the purpose of the Declaration of Helsinki provide ethical principles for the World Medical Association What was the purpose of the Belmont Report provide basic ethical principles, boundaries between practice and research Class I Device Low risk, examples include bandages, exam gloves, Q-tips Class II Device Medium risk, examples include powered wheelchairs, infusion pumps, surgical drapes Class III Device Highest risk, examples include heart valves, breast implants, pacemakers Principle Investigator Duties:
- responsible for all study activities (and training delegates)
- Leading the team
- Making medical decisions
- Providing oversight for the study by answering questions from study subjects
- Ensuring the safety and welfare of human subjects
- Being involved or delegating the informed consent process, and ensuring that the study team and subjects enrolled in the study are adhering to the study protocol CRC Duties
- Prescreening subjects for eligibility
- Recruiting subjects
- Obtaining informed consent
- Explaining the study to subjects and answering their questions
- Retrieving laboratory and diagnostic test results
- Scheduling study visits
- Recording study data in the case report forms (CRFs)
- communicates and reports AE/SAEs
- preparing submission to IRB, maintaining and updating regulatory binder 45 CFR 46 HHS regulations for the protection of human subjects in research Study Objectives outcome measures used to assess the results of a clinical trial. Ex: AEs and measurements of disease progression or survival
