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Socra > ICH E6 GCP > Flashcards

ICH E6 GCP Flashcards

1
Q

For what is ADR an acronym?

A

Adverse drug reaction.

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2
Q

Define adverse drug reaction.

A

An ADR is a noxious and unintended response to
1. a new medicinal product,
2. a new usage of a medicinal product, or
3. a marketed medicinal product.

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3
Q

To be classified as an ADR, a causal relationship
between a medicinal product, an unintended response
to that product must be at least a reasonable
possibility. TRUE OR FALSE?

A

True

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4
Q

ADR and adverse event are synonymous terms. TRUE
OR FALSE?

A

false

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5
Q

In the ICH-GCP guidelines, what is the term used to
describe laws and regulations governing the conduct of
clinical trials in a particular jurisdiction?

A

Laws and Regulations are referred to as Applicable
Regulatory Requirements.

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6
Q

Define the term Approval as it relates to an IRB/IEC?

A

Approval refers to an AFFIRMATIVE decision that the
clinical trial has been reviewed may be conducted in
accordance with defined restraints.

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7
Q

An audit is a systematic and independent examination
of trial-related activities& documents. TRUE or FALSE?

A

true

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8
Q

Define the purpose of an audit.

A

An audit evaluates whether trial-related activities were
conducted and documented in accordance with The
Protocol, Sponsor’s SOPs, GCPs, and Regulatory
Requirements.

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9
Q

An audit certificate indicates that the auditors approve
of a site’s activities. TRUE OR FALSE?

A

false

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10
Q

Who completes an audit report & what information
does it contains?

A

Representatives of a sponsor complete the report that
contains the results of an audit.

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11
Q

What is the audit trail and what function does it serve?

A

An audit trail is documented results that allow
reconstruction of a particular sequence of events.

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12
Q

Blinding & masking refer to the same procedure. TRUE
OR FALSE?

A

True

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13
Q

In a single-blinded study, the monitor is generally
unaware of treatment assignments. TRUE OR FALSE?

A

false

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14
Q

Who is typically unaware of treatment assignments
when a study is double blinded?

A

In a double-blinded study, subject, investigator,
monitor. In some cases data analysts are unaware of
the treatment assignments.

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15
Q

Must a case report form (CRF) always be a printed
document?

A

No. Case reports forms can be printed, optical, or
electronic documents.

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16
Q

Clinical trial & clinical study are synonymous terms.
TRUE OR FALSE?

A

true

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17
Q

Identify two of the objectives of clinical trials.

A

Clinical trials seek to discover/study: Clinical,
pharmacological, or pharmacodynamic effects,
Associated adverse reactions, ADME profiles, Safety
and efficacy of a product.

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18
Q

The clinical trials/study reports integrates the clinical
and statistical description, presentation, and analysis into single report. TRUE OR FALSE?

A

true

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19
Q

What is a comparator product?

A

A comparator is an investigational or marketed product
(i.e. active control) or a placebo used as a reference in
a clinical trial.

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20
Q

Define ‘compliance” as it refers to clinical trials.

A

Compliance, in a clinical trial is adherence to all trialrelated
requirements as well as GCPs and applicable
regulatory requirements.

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21
Q

Confidentiality pertains to what types of information?

A

Confidentiality prevents disclosure of the sponsor’s
proprietary information and the subject’s identity.

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22
Q

A clinical protocol may serve as the basis for a contract
b/w two parties. TRUE OR FALSE?

A

true

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23
Q

In what type of trials does a sponsor generally organize
a coordinating committee?

A

Coordinating committees are usually formed to oversee
multi-center trials.

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24
Q

What is the role of the Coordinating Investigator?

A

The coordinating Investigator monitors the activities of
the investigators at different centers during a multicenter
trial.

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25
Q

How are Contract Research Organizations (CRO) used
in a clinical trial?

A

The sponsor may hire a CRO, which can be an
individual or an organization, to perform certain trial related
duties and functions.

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26
Q

What rights does direct access give a member of a
regulatory authority, sponsor, monitor, or auditor?

A

Direct access allows the individuals to
examine ,analyze, verify and reproduce any records
deemed important to evaluation of the trial.

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27
Q

Documentation, as it pertains to a clinical trial, is
limited to the results of trial procedures. TRUE OR FALSE?

A

false

28
Q

What aspects of a clinical trial are affected by Good
Clinical Practices (GCPs)?

A

All aspects of a clinical trial, from design through
reporting are governed by GCPs.

29
Q

How is the term “Essential Documents” defined?

A

Essential documents are those records that individually
& collectively, permit evaluation of the conduct of
the study and the quality of the data produced.

30
Q

What is the Intended function of GCPs?

A

GCPs provide assurance that the data and reported
results are credible and accurate that the rights,
integrity, andconfidentiality of the trial subjects are
protected.

31
Q

What is IDMC?

A

IDMC refers to Independent Data Monitoring
Committee. It may also be called the Data and Safety
Monitoring Board or Monitoring Committee or Data
Monitoring Committee.

32
Q

What is the role of IDMC?

A

The IDMC assess trial progress, safety data, and
clinical efficacy endpoints. It may also recommend
whether to continue, modify or stop a trial.

33
Q

In what instance may a trial require an impartial
witness?

A

An Impartial witness may be required during Informed
consent process if the subject or subject’s legal
representative cannot read.

34
Q

What group is responsible for ensuring the protection
of the rights, safety and well-being of human subjects
involved in a trial?

A

The Institutional review Board (IRB) or the
Independent Ethics Committee (ICE) is responsible for this task

35
Q

How is Informed consent documented?

A

Informed consent is documented by means of a
written, signed and dated informed consent form.

36
Q

A regulatory authority may only inspect documents,
facility, records, and resources that are kept at the trial
site. TRUE OR FALSE?

A

false

37
Q

What is the definition of a medical institution?

A

A medical Institution is any public or private entity or
agency or a medical or dental facility where clinical
trials are conducted.

38
Q

What is the function of IRB?

A

The IRB ensures the Protection of the rights, safety,
and well- being of the human subjects involved in a
trial.

39
Q

What information is included in the Interim Clinical
trial/study report?

A

The Interim report presents and evaluates intermediate
results based on analyses performed during the trial.

40
Q

What is the investigational product?

A

An investigational product is a pharmaceutical form of
an active ingredient or placebo being tested or used as
a reference in clinical trial.

41
Q

When is the term Principal Investigator is used?

A

Principal Investigator (PI) refers to the lead
investigator in a study that is conducted by a team of
individuals located at the same study site.

42
Q

What is the meaning of “investigator/institution” when
used in conjunction with clinical trial?

A

The term connotes an “and /or” relationship) i.e., the
investigator and/or institution).

43
Q

What is included in the Investigator’s Brochure?

A

The Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational products that is relevant to its impact on human subjects.

44
Q

A legally acceptable representative must be an
individual known to the subject. TRUE OR FALSE?

A

false

45
Q

How often does monitor complete a monitoring report?

A

The monitor completes a report after each site visit
and/or other trial related communication, according to
the sponsor’s SOPs.

46
Q

What is a non clinical study?

A

A non-clinical study is a biomedical study that does not
involve human subjects.

47
Q

What is the purpose of a protocol?

A

A protocol describe the objectives ,design,
methodology, statistical considerations &
organization of a trial. It also generally provides the
background and rationale, although these may be
included in referenced documents.

48
Q

Protocol Amendments are only prepared when there
has been a change to the protocol. TRUE OR FALSE?

A

false

49
Q

What is the process called that is responsible for
ensuring that all planned and systematic actions are
designed and implemented in compliance with GCPs?

A

QUALITY ASSURANCE is responsible for GCP
compliance.

50
Q

What is the term used to describe the operational
techniques and activities used to verify that quality-related
requirements have been fulfilled?

A

QUALITY CONTROL accomplishes this function.

51
Q

What technique is used to assign trial subjects to
treatment or control groups so as to reduce bias?

A

Randomization is used to introduce an element of
chance.

52
Q

What is the difference between the terms “regulatory
authorities” and “competent authorities”?

A

There is no difference. The two terms are synonymous.

53
Q

What are two major functions of regulatory authorities?

A

The two major functions are
1. To review submitted clinical data, and
2. To conduct investigations of documents, facilities,
records and related resources.

54
Q

What is the term for an unexpected event that results
in death or is life threatening?

A

Such an event is called serious adverse event. (SAE) or
serious adverse drug reaction.

55
Q

What documents are considered to be source data?

A

Source data includes all information in original records and certified copies of the original records of clinical findings, observations or other activities that are needed to reconstruct and evaluate the trial.

56
Q

Transcriptions must be certified after verification to
qualify as source documents. TRUE OR FALSE?

A

true

57
Q

What is the definition of a sponsor?

A

A sponsor is an individual, company, institution or organization that takes responsibility for initiation, management, and /or financing of a clinical trial.

58
Q

What is the definition of sponsor-investigator?

A

A sponsor-investigator is an individual who both initiates and conduct a clinical trial and oversees dispensation of the investigational product.

59
Q

A sponsor-investigator can be either an individual or a corporation. TRUE OR FALSE?

A

false

60
Q

What is the purpose of Standard Operating Procedure

A

SOP is designed to ensure uniformity of performance of
a specific function.

61
Q

Resident and research fellow can be used as sub-investigators.
TRUE OR FALSE?

A

true

62
Q

Only individuals who receives the investigational
products are considered subjects/trial subjects. TRUE
OR FALSE?

A

false

63
Q

What is the definition of subject ID code?

A

A subject ID code is unique identifier assigned by an
investigator that is designed to protect subject anonymity and used in lieu of subject name on study-related
documents.

64
Q

What is the term used to describe an adverse reaction
when its nature or severity is not described in applicable product information (the investigator’s Brochure or package insert)?

A

Such a reaction is termed as an unexpected adverse drug reaction.

65
Q

What is the definition of a vulnerable subject?

A

Vulnerable subjects are individuals who are incapable
of giving informed consent or whose voluntary participation in a study may be influenced by their health, social, economic, or employment condition.

66
Q

How is the well being of the trial subject is defined?

A

Well being is defined as the physical and mental
integrity of the subjects involved in a clinical trial.

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