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ACRP - CCRC Exam > ICH Abbreviations - and definitions > Flashcards

ICH Abbreviations - and definitions Flashcards

1
Q

ADR

A

(Adverse Drug Reaction ) a reaction from a treatment/ intervention where there is evidence of direct causal relationship between the reaction and the drug.

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2
Q

AE

A

Adverse event - an untoward event/ reaction that occurred during participation in the trial, whether directly related or not.

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3
Q

ALT

A

Alanine aminotransferase
-assess liver damage

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4
Q

AST

A

Asparate aminotransferase (enzyme released when liver is damaged)
-assess liver damage

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5
Q

BP

A

Blood pressure - mm Hg. The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats.

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6
Q

BUN

A

Blood Urea Nitrogen
-used to measure kidney function

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7
Q

CK

A

Creatine Kinase - found in heart, brain, skeletal muscle, and other tissue.
-Measures muscle damage.

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8
Q

DCF

A

Data Clarification Form

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9
Q

GCP
GLP
GMP

A
  • good clinical practices
  • good laboratory practices
  • good manufacturing practices
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10
Q

hCG

A

human chorionic gonadotropin - tested in urine for pregnancy or birth defects, uterine/ testicle cancer

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11
Q

ICH

A

International Conference Harmonization

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12
Q

LAR

A

Legally Acceptable Representative

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13
Q

MOA

A

Monoamine Oxidase - detects deficiency, mostly males. mild intellectual disability and behavioral problems beginning in early childhood - Autism/ ADHD

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14
Q

PK

A

Pharmacokinetics - refers to the movement of drug into, through, and out of the body—the time course of its absorption, bioavailability, distribution, metabolism, and excretion.

*what the body does to the drug

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15
Q

QA /QC

A

Quality Assurance / Quality Control

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16
Q

SUSAR

A

Suspected Unexpected Serious Adverse Reaction - untoward and unintended response to a study drug, which is not listed is the applicable product information, and meets one of the following serious criteria: death, life threatening, prolonged hospitalization, persistent disability, congenital anomaly or birth defect

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17
Q

Bias (Statistical & Operational)

A

The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the ESTIMATE OF A TREATMENT EFFECT DEVIATE FROM ITS TRUE VALUE

  • Bias introduced through deviations in conduct is referred to as ‘operational’ bias.
  • Flaw in the experiment design or data collection process ‘statistical’. examples are sampling, treatment assignment, etc
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18
Q

Blind Review

A

The checking and assessment of data during the period of time between trial completion (the last observation on the last subject) and the breaking of the blind, for the purpose of finalizing the planned analysis.

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19
Q

Content Validity

A

The extent to which a variable (e.g. a rating scale) measures what it is supposed to measure.

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20
Q

Generalization

A

The extent to which the findings of a clinical trial can be reliably extrapolated from a study to a broader patient population and clinical settings

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21
Q

Double-Dummy

A

A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical.

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22
Q

Dropout

A

A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the study protocol.

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23
Q

Full Analysis Set

A

The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle.

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24
Q

(DMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

A

An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

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25
Q

Intention-To-Treat Principle

A

The principle that asserts that the effect of a treatment policy can be best assessed by evaluating on the basis of the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given

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26
Q

Interim Analysis

A

Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial

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27
Q

Meta-Analysis

A

The formal evaluation of the quantitative (data expressed by a number) evidence from two or more trials bearing on the same question

*statistical combination of the results of multiple studies addressing a similar research question

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28
Q

Multicentre Trial

A

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator

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29
Q

Safety & Tolerability

A

1) Safety of a medical product concerns the MEDICAL RISK TO THE SUBJECT (assessed by medical tests, vitals, AEs, ECGs, etc

2) Tolerability of the medical product represents the DEGREE TO WHICH OVERT ADVERSE EFFECTS CAN BE TOLERATED BY THE SUBJECTS

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30
Q

Per Protocol Set

A

The set of data generated by the subset of subjects who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment

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31
Q

Statistical Analysis Plan

A

a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.

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32
Q

Treatment Effect

A

An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments.

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33
Q

Treatment Emergent

A

An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.

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34
Q

Adverse Drug Reaction (ADR)

A

all noxious and unintended responses to a medicinal product related to any dose that has a least a reasonable possibility of being related to the drug

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35
Q

Adverse Event (AE)

A

any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment

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36
Q

Applicable Regulatory Requirements

A

any law/regulations addressing conduct of clinical trials and IP

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37
Q

IRB Approval

A

affirmative decision of the IRB that the trial has been reviewed and may be conducted at the site within the constraints set forth by the IRB, institution, GCP, and regulatory requirements

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38
Q

Audit

A

systematic and independent exam (usually by sponsor or institution) of trial related activities and documents to determine if trial activities were conducted, data collected/analyzed, and accurately reported according to protocol, SOPs, GCP, and regulatory requirements

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39
Q

Audit Trail

A

documentation that allows reconstruction of course of events

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40
Q

Blinding/Masking

A

procedure in which one or more parties to the trial are kept unaware of treatment assignment

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41
Q

Clinical Trial

A

investigation in human subjects intended to discover/verify the clinical, pharmacological, and pharmacodynamic effects of an IP and identify any AEs to product and ascertain its safety and efficacy

42
Q

Clinical Trial Report

A

written description of trial in human subjects in which clinical and statistical description, presentations, and analyses are fully integrated in a single report

43
Q

Comparator

A

IP or marketed product (active control) or placebo used as reference in clinical trial

44
Q

Compliance

A

adherence to all trial related requirements, GCPs, and regulatory requirements

45
Q

Confidentiality

A

prevention of disclosure of a sponsor’s proprietary information or subjects identity

46
Q

Contract

A

written, dated, and signed agreement between parties that sets out arrangements on delegation of tasks, obligations, and financial matters

47
Q

Contract Research Organization

A

organization or person contracted by sponsor to perform sponsor’s trial related duties and functions

48
Q

Direct Access

A

permission to exam, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial

49
Q

Documentation

A

all records in any form that describe or record the methods, conduct, and results of a trial

50
Q

Essential Documents

A

documents which individually and collectively permit evaluation of the conduct of a study and quality of data produced
*docs in Regulatory Binders

51
Q

Good Clinical Practice (GCP)

A

standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that data and results are credible and accurate and rights of trials subjects are protected

52
Q

IDMC/DSMB

A

independent data monitoring committee established by a sponsor to assess at intervals the progress of a clinical trial, safety data, and efficacy endpoints and to recommend to the sponsor whether to continue, modify, or stop a trial

53
Q

Impartial Witness

A

person, independent or trial who can’t be influenced, who attends the informed consent process if the subject or LAR cant read, who confirms ICF process was completed.
*also signs ICF

54
Q

Informed Consent

A

process by which subject voluntary confirmed willingness to participate in a trial after having been informed of all aspects of trial relevant to subject’s decision. Documented by means of written, signed, and dated informed consent form

55
Q

Inspection

A

act of regulatory authorities of conducing official review of documents, facilities, records, and any other resources related to clinical trial. May be located at site, sponsor/CRO facilities, or any other establishments deemed appropriate by reg. authorities

56
Q

Institution

A

entity or agency where clinical trials are conducted

57
Q

Institutional Review Board (IRB)

A

independent body consisted or medical, scientific, and non scientific members whose responsibility is to ensure protections or rights, safety, and well being of human subjects by reviewing, approving, and continuing review of protocol and amendments and other methods and material to be used in informed consent process

58
Q

Interim Clinical Trial Report

A

report of intermediate results and their evaluation based on analyses performed during a trial

59
Q

Investigational Product:

A

pharmaceutical form of active ingredient or placebo being tested or used as reference in clinical trial
-includes product with marketing authorization when used in a different way than approved
-used for an unapproved indication

60
Q

Investigator

A

person responsible for conduct of clinical trial at a trial site. In a team at trial site – investigator is responsible leader of team

61
Q

Investigator Brochure

A

complication of clinical and nonclinical data on the IP which is relevant to study of IP in human subjects

62
Q

Legally Acceptable Representative

A

individual or other body authorized under law to consent on behalf of subject in a clinical trial

63
Q

Monitoring

A

act of overseeing the progress of clinical trial and ensuring it is conducted, recorded, and reported in accordance to protocol, SOPs. GCP, and regulatory requirements

64
Q

Trial Site

A

location where trial related activities are actually conducted

65
Q

Unexpected Adverse Drug Reaction

A

AE which the nature or severity of which is not consistent with the applicable product information (eg IB)

66
Q

Vulnerable Subjects

A

individuals whose willingness to volunteer for a trial may be unduly influenced by expectation, benefits, retaliatory response from senior members in a hierarchy

67
Q

Well-being

A

physical and mental integrity of the subject in a trial

68
Q

Monitoring Plan

A

document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial
-determined by sponsor

69
Q

Monitoring Report

A

written report from monitor to sponsor after each site visit and other trial related communication depending on sponsor’s SOPs

70
Q

Nonclinical trial

A

biomedical studies not performed on human subjects

71
Q

Protocol

A

document that describes objective, design, methodology, statistical considerations, and organization of a trial

72
Q

Protocol Amendment

A

written description of a change or a formal clarification of protocol

73
Q

Quality Assurance

A

all planned and systematic actions that are established to ensure that the trial is performed and data generated, documented, and reported are compliance with GCP and reg. requirements

74
Q

Quality Control

A

operational techniques and activities within QA system to verify requirements for quality of trial related activities have been fulfilled

example- monitoring

75
Q

Randomization

A

process of assigning trial subjects to treatment or control groups using chance to reduce bias

76
Q

Regulatory Authorities

A

bodies having power to regulate

77
Q

Define a Serious Adverse Event

A

untoward medical occurrence at any dose that
- results in death
- lift threatening
- requires inpatient hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability/incapacity
- congenital anomaly/birth defect

78
Q

Source Data

A

all info in original records and certified copies of clinical findings, observations, or other activities in a clinical trial necessary for reconstruction and evaluation of the trial – contained in source documents

79
Q

Source Documents

A

original documents, data, and records (examples hospital records, clinical and office charts, laboratory notes, CRFs)

80
Q

Sponsor

A

individual, company, institution, or organization which takes responsibility for the initiation management, and/or financing a clinical trial

81
Q

Sponsor-Investigator

A

individual who both initiates and conducts a clinical trial and under whose immediate direction the IP is administered to, dispensed to, or used by a subject.

82
Q

Standard Operating Procedures

A

detailed, written instructions to achieve uniformity of the performance of a specified function

83
Q

Sub investigator

A

individual member of clinical trial team designated and supervised by the investigator at a site that performs critical trial related procedures and makes important trial related decisions

84
Q

Subject

A

individual who participate in clinical trial

85
Q

Subject Identification Code

A

unique identifier assigned by the investigator to each trial subject to protect subjects ID

86
Q

Regulation vs Guidelines

A

regulation: issued by regulatory authorities (example FDA)
- Only applicable in country’s jurisdiction

Guidelines: global standards developed by International Council for Harmonization (ICH), example GCP
- Helps enhance efficiency and cost effectiveness of research

87
Q

ICH E2A

A

Clinical Safety Data Management

88
Q

ICH E8

A

General Considerations

89
Q

ICH E9

A

Statistical Principles

90
Q

ICH E6

A

GCP

91
Q

ICH E11

A

pediatric drug development

92
Q

TSH

A

Thyroid Stimulating Hormone

test used to assess the function of the thyroid gland

93
Q

LDH

A

Lactate Dehydrogenase

check for damage to the tissue of the heart, liver, kidney, muscles, brain, blood cells, and lungs

94
Q

BUN

A

Blood Urea Nitrogen – kidney function test

95
Q

Hct

A

Hematocrit - blood test measuring the percentage of the volume of whole blood that is made up of red blood cells

96
Q

Therapeutic Efficacy

A

capacity for beneficial change

97
Q

Phase 1

A

tolerability of dose ranges
safety
PK and PD

98
Q

Phase 2

A

explore therapeutic efficacy

99
Q

Phase 3

A

confirm therapeutic benefit

100
Q

Phase 4

A

after drug approval
beyond prior demonstration of safety, efficacy, and dose definition

ACRP - CCRC Exam (14 decks)

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