Vocabulary Words & Definitions Flashcards
(105 cards)
1
Q
Suspected Adverse Reaction
A
Any AE w/reasonable possibility that the drug caused the AE. For IND safety reporting “reasonable possibility” means there is evidence to suggest a causal relationship.
2
Q
Unexpected AE or Unexpected Suspected Adverse Reaction
A
An AE or suspected adverse reaction is “unexpected” if not listed in the IB or not listed at the specificity or severity observed. If an IB is not required or available, then the reaction is unexpected if not consistent with the risk info in the general investigational plan or elsewhere in the current application.
3
Q
Life-threatening AE or life-threatening suspected adverse reaction
A
An AE or suspected adverse reaction is considered life-threatening if the investigator or sponsor believes it places the subject at immediate risk of death.
4
Q
Adverse event (AE)
A
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
5
Q
Research
A
A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge.
Does not include:
- Scholarly and journalistic activity
- public health surveillance
- activities for criminal justice purposes authorized by law or court order for criminal justice or criminal investigative purposes
- Authorized operational activities for homeland security, intelligence, defence.
6
Q
Human Subject
A
A living individual about whom an investigator conducting research obtains info/biospecimens through intervention or interaction with the subject and obtains/uses/studies/ analyzes/generates private identifiable info or identifiable biospecimens
7
Q
OHRP
A
Office of Human Research Protections (Part of the US Department of Health and Human Services) - Oversight body for guidance to IRBs and researchers conducting human subjects research.
8
Q
Minimal Risk
A
the probability and magnitude of harm or discomfort anticipated in the research are no greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46.102(j))
9
Q
Clinical Research
A
A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on biomedical or behavioral health-related outcomes
10
Q
FWA
A
Federal Wide Assurance - an organization’s commitment to comply with federal human subjects regulations (45 CFR 46). (Required by the HHS)
11
Q
Federal Policy for the Protection of Human Subjects
A
The Common Rule (45 CFR Part 46 A)
12
Q
Unanticipated Problem
A
Events that may indicated an increased risk to subjects or other that are not described (type, severity, frequency) in the protocol & related documents, and are possibly related to participation.
(Remember: URG. U = Unexpected, R = possibly Related, G = Greater risk of harm for subjects or others)
13
Q
Broad Consent
A
Prospective consent for unspecified future research
14
Q
Validation of Computer Systems
A
Defined by ICH E6 (Section 1.65) - Process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning.
15
Q
Form 1572
A
“Statement of Investigator” (for INDs)
16
Q
NDA
A
New Drug Application (to the FDA)
17
Q
Good Clinical Practice (GCP)
A
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials.
18
Q
Pharmacodynamics
A
Describe the effects of the agent while in the body.
19
Q
Pharmacogenomics
A
The use of genetic information to predict whether a drug will help make a patient well or ill.
20
Q
Pharmacokinetics
A
Describes how the agent moves through and is excreted from the body.
21
Q
Certified Copy
A
Defined by ICH E6 - A record can only be a certified copy (paper or electronic) if it has been verified or generated through a validated process
22
Q
ICH
A
International Council for Harmonization (previously International Conference on Harmonization)
23
Q
ALCOA-C
A
Attributable
Legible
Contemporaneous
Original
Accurate
Complete
24
Q
Sponsor
A
The entity who takes responsibility for and initiates a clinical investigation. The sponsor is often, but not always, the entity that funds the clinical research.
25
CBER
Center for Biologics Evaluation and Research
26
CDER
Center for Drug Evaluation and Research
27
CDRH
Center for Device and Radiological Health
28
CTCAE
Common Terminology Criteria for Adverse Events
29
Form 482
Notice of Inspection
30
Certified Copy
A copy of the original record that has been verified to have the same information, including data that describe the context, content, and structure, as the original.
31
Essential Documents
Documents that collectively permit the evaluation of the conduct of the study and the quality of the data produced. Should be kept for 2 years after the last approval of a marketing application in an ICH region or at least 2 years have elapsed since discontinuation of clinical development, unless required for longer by regulatory requirement or agreement w/sponsor.
32
Form 1571
Cover sheet for an IND application
33
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)
34
Biometric
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)
35
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)
36
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)
More secure than electronic signatures
37
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)
38
Electronic Signature
A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be a legally binding equivalent of the handwritten signature. (21 CFR, Sec. 11.3)
Less secure than digital signatures
39
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)
40
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)
41
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)
42
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)
43
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)
44
Act
The Food, Drug and Cosmetic Act, as amended.
45
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)
46
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)
47
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)
48
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)
49
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 daily life or during the performance of routine physical or psychological examinations or tests. (21 CFR, sec. 50.3)
50
Assent
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)
51
Ward
A 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)
52
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)
53
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 no sufficient time to obtain IRB approval. (21 CFR, sec. 56.102)
54
FDA 510K
A premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Can only be used for Class II and some Class I devices. (Some Class I's are exempt).
55
Contract Research Organization
An organization that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA. (21 CFR, sec. 312.3)
56
IND
An investigational new drug application. Is synonymous with "Notice of Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3)
57
Independent Ethics Committee (IEC)
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. (21 CFR, sec. 312.3)
58
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. (21 CFR, sec. 812.3)
59
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)
60
Investigational Device
A device, including a transitional device that is the object of investigation. (21 CFR, sec. 812.3)
61
Monitor
When used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of an investigation. When used as a verb, means to oversee and investigation. (21 CFR, sec. 812.3)
62
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)
63
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)
64
Termination
A discontinuance, by a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3)
65
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)
66
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)
67
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)
68
Viable
As it pertains to the neonate, means being able after delivery to survive.
69
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)
70
Adverse Drug Reaction (ADR)
All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1)
71
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)
72
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)
73
Audit Certificate
A declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7)
74
Audit Report
A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8)
75
Audit Trail
Documentation that allow reconstruction of the course of events. (ICH GCP E6 1.9)
76
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 E6 1.13)
77
Comparator (Product)
An investigational or marketed product (i.e. active control), or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14)
78
Compliance
Adherence to all the trial related requirements, GCP requirements and the applicable regulatory requirements. (ICH GCP E6 1.15)
79
Confidentiality
Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH GCP E6 1.16)
80
Coordinating Committee
A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18)
81
Coordinating Investigator
An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. (ICH GCP E6 1.19)
82
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)
83
Documentation
All 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)
84
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)
85
Good Clinical Practice (GCP)
A 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)
86
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)
87
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)
88
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)
89
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 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)
90
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)
91
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)
92
Nonclinical Study
Biomedical studies not performed on human subjects. (ICH GCP E6 1.41)
93
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)
94
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)
95
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)
96
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.
97
Minimal Risk
the probability and magnitude of anticipated harm or discomfort are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
98
Form 3454
Certification of financial interest and arrangements of clinical investigators - used for when investigators don’t have any FDA required financial disclosures
99
Form 483
Inspectional Observations (FDA)
100
Form 3500
Voluntary safety reporting of adverse events and product problems
101
Form 3500A
Mandatory safety reporting by user facilities, distributors, and manufacturers
102
Form 3455
Disclosure of financial interest and arrangements of clinical investigators - submitted when an investigator has a significant financial disclosure
103
SOCRA
Society of Clinical Research Associates
104
ICH
International Council for Harmonization
105
PMA
Pre Market Approval
