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Glossary ICH E6(R2) Flashcards

1
Q

Adverse Drug Reaction (ADR)

New medicinal product

A

all noxious and unintended responses to a medicinal product related to any dose

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2
Q

Adverse Drug Reaction (ADR)

marketed medicinal products

A

a response to a drug which is noxious and unintended and which occurs at doses normally used in people for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function

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3
Q

Adverse Event (AE)

A

Any untoward medical occurrence which does not necessarily have a causal relationship with the treatment.

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4
Q

Protocol Amendment

A

A written description of a change(s) to or formal clarification of a protocol.

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5
Q

Applicable Regulatory Requirement(s)

A

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

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6
Q

IRB Approval

A

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.

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7
Q

Audit

A

A systematic and independent examination of trial related activities and documents to determine whether activities were conducted and the data were managed according to the protocol, sponsor’s SOPs, GCP and applicable regulatory requirement(s).

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8
Q

Audit Certificate

A

A declaration of confirmation by the auditor that an audit has taken place

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9
Q

Audit Report

A

A written evaluation by the sponsor’s auditor of the results of the audit.

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10
Q

Audit Trail

A

Documentation that allows reconstruction of the course of events.

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11
Q

Blinding/Masking

A

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).

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12
Q

Single-blinding

A

Subjects are unaware of the treatment assignment

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13
Q

double-blinding

A

subject(s), investigator(s), monitor, and, in some cases, data analyst(s) are unaware of the treatment assignment(s)

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14
Q

Case Report Form (CRF)

A

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.

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15
Q

Clinical Trial/Study

A

Any investigation in human subjects intended to discover or verify:

  • -the effects of an investigational product(s)
  • -and/or to identify any adverse reactions to an investigational product(s)
  • -and/or to study the safety and/or efficacy of an investigational product(s)
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16
Q

Clinical Trial/Study Report

A

A written description of a trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report

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17
Q

Comparator (Product)

A

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.

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18
Q

Compliance

A

Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.

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19
Q

Confidentiality

A

Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

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20
Q

Contract

A

A written, dated, and signed agreement between two or more involved parties.

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21
Q

Coordinating Committee

A

A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.

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22
Q

Coordinating Investigator

A

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.

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23
Q

Contract Research Organization (CRO)

A

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.

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24
Q

Direct Access

A

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

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25
Documentation
All records, in any form, that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
26
Essential Documents
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced
27
Good Clinical Practice (GCP)
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, 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 trial subjects are protected.
28
IDMC, DSMB, DSMC
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.
29
Impartial Witness
An independent person who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
30
IEC/IRB
An independent body responsible for protecting the rights, safety and well-being of human subjects involved in a trial
31
Informed Consent
Voluntarily confirmation by a subject of 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.
32
Inspection
An official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial
33
Institution (medical)
Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
34
Response (to a drug)
"response" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility (i.e. the relationship cannot be ruled out)
35
Types of AEs
Any unfavorable or unintended sign, abnormal laboratory finding, symptom, or disease temporally associated with the use of a medicinal or investigational product, whether or not related to the medicinal or investigational product
36
contents covered by trial contract
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.
37
Role of IEC/IRB
Review and approve 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.
38
Interim Clinical Trial/Study Report
A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
39
Investigational Product
A pharmaceutical product or device being - -tested or used as a reference in a clinical trial - -being used in a way different from the approved form - -being used for an unapproved indication - -being used to gain further information about an approved use
40
Investigator
A person responsible for the conduct of the clinical trial at a trial site.
41
Investigator's Brochure
A compilation of the clinical and nonclinical data on the investigational product(s)
42
Legally Acceptable Representative
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
43
Monitoring
The act of overseeing the progress of a clinical trial
44
A clinical trial be conducted in accordance with. . .
- -the protocol - -Standard Operating Procedures (SOPs) - -Good Clinical Practice (GCP) - -applicable regulatory requirements
45
Monitoring Report
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
46
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.
47
Nonclinical Study
Biomedical studies not performed on human subjects.
48
Source Documents
Original documents, data, and records
49
Protocol describes . . .
objective(s), design, methodology, statistical considerations, and organization of a trial
50
Quality Assurance (QA)
planned and systematic actions to ensure a trial is conducted according to GCP and applicable regulatory requirements
51
Quality Control (QC)
operational techniques and activities undertaken within QA
52
Randomization
assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
53
Regulatory Authorities
Bodies having the power to regulate clinical trials
54
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
Any untoward medical occurrence that at any dose: - -results in death - -is life threatening - -requires inpatient hospitalization or prolongs existing hospitalization - -results in persistent or significant disability/incapacity - -results in congenital anomaly
55
Source Data
information in original records needed for the reconstruction and evaluation of the trial
56
Sponsor
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
57
Sponsor-Investigator
An investigator who both initiates and conducts a clinical trial
58
Standard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity of the performance of a specific function.
59
Subinvestigator (Sub-I)
Member of study team designated and supervised by the investigator to perform critical trial-related procedures and make important trial-related decisions
60
Subject
An individual who participates in a clinical trial
61
Subject Identification Code
A unique identifier assigned by the investigator to each subject to protect the subject's identity
62
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information
63
Where is drug/device information found
Investigator's Brochure (unapproved product) or package insert (approved product)
64
Vulnerable Subjects
medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, prisoners, patients with incurable diseases, persons in nursing homes unemployed or impoverished persons, patients in emergency situations, ethnic minority groups homeless people, nomads, refugees, minors, those incapable of giving consent
65
Well-being (of the trial subjects)
The physical and mental integrity of the subjects participating in a clinical trial.
66
NDA
New Drug Applications
67
PMA
Premarket Approval Applications
68
CAPA
Corrective and preventative action plan
69
RCA
root cause analysis
70
Steps in developing a CAPA
1) determine root cause; 2) create an action plan; 3) implement plan; 4) check for effectiveness
71
included in and IDE submission to the FDA
Report of prior investigations, summary of the investigational plan, and copies of device labeling.

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