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SOCRA_2015 > ICH Guideline for GCP > Flashcards

ICH Guideline for GCP Flashcards

1
Q

The Guideline for Good Clinical Practice was created at/by:

a) Food and Drug Administration
b) International Conference on Harmonisation
c) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
d) Trials of War Criminals
e) World Medical Association

A

b) International Conference on Harmonisation

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2
Q

The international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects is known as:

a) The International Conference on Harmonisation (ICH)
b) Good Clinical Practice (GCP)
c) The Belmont Report
d) The Declaration of Helsinki

A

b) Good Clinical Practice (GCP)

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3
Q

The consent form should include (mark all that apply):

a) duration of participation
b) compensation
c) benefits, risks, and alternatives
d) purpose of the trial
e) records identifying subjects will be published

A

a) duration of participation
b) compensation
c) benefits, risks, and alternatives
d) purpose of the trial

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4
Q

Essential documents should be retained until at least ____ years after the last approval of a marketing application.

a) 5
b) 7
c) 2
d) 1

A

c) 2

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5
Q

A(n) ________ is:

A person responsible for the conduct of the clinical trial at a trial site.

A

Investigator

1.34

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6
Q

A(n) ________ is:
An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.

A

Sponsor

1.53

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7
Q

A ________ is:
A document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

A

Case Report Form (CRF)

1.11

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8
Q

A ________ is:

A document that describes the objectives, design, methodology, statistical considerations, and organization of a trial.

A

Protocol

1.44

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9
Q

Quality _______ is:
Planned 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 Practice (GCP) and the applicable regulatory requirements.

A

[Quality] Assurance (QA)

1.46

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10
Q

Quality ________ is:
Operational techniques and activities undertaken within the quality assurance system to verity that requirements for quality of the trial-related activities have been fulfilled.

A

[Quality] Control (QC)

1.47

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11
Q

The IRB/IEC should consist of at least _____ members and should retain relevant records (e.g., written procedures, membership lists, submitted documents, minutes of meetings, etc.) for a period of at least _____ years after completion of the trial.

a) 3 members; 5 years
b) 5 members; 5 years
c) 5 members; 3 years
d) 5 members; 2 years

A

c) 5 members; 3 years

  1. 2
  2. 4
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12
Q

Prior to participation in the trial, the subject should receive a copy of the signed and dated written informed consent form.

true
false

A

true

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13
Q

The purpose of trial monitoring are to verify that:

a) the rights and well-being of human subjects are protected
b) the reported trial data are accurate, complete, and verifiable from source-documents
c) the conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with the applicable regulatory requirements
d) all of the above

A

d) all of the above

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14
Q

According to GCP, those bodies that review submitted clinical data and conduct inspections, with the power to regulate, include which of the following (mark all that apply):

a) Competent Authorities
b) Regulatory Authorities
c) Independent Data Monitoring Committee
d) Investigator
e) Sponsor

A

a) Competent Authorities
b) Regulatory Authorities

1.49

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15
Q

The sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO.

true
false

A

true

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16
Q

The investigator is not allowed to deviate from the protocol without agreement by the sponsor and prior review and documented approval/favorable opinion from the IRB/IEC of the amendment.

true
false

A

false

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17
Q

The principles of ICH GCP are derived from which of the following:

a) The Belmont Report
b) The Declaration of Helsinki
c) The Nuremberg Code
d) all of the above

A

b) The Declaration of Helsinki

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18
Q

Who is reponsible for providing the IRB/IEC with a current copy of the Investigator’s Brochure (and an updated copy if the IB is updated during the trial)?

a) the Institution where the trial is taking place
b) Sponsor
c) Investigator
d) either a or c

A

d) either a or c

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19
Q

During a subject’s participation in the trial, the subject or the subject’s legally acceptable representatives should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.

true
false

A

true

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20
Q

The objective of the ICH GCP Guideline is to provide a unified standard for __________ (select all that apply) to facilitate the mutual acceptance of clinical data by the regulatory authorities.

a) United States
b) Australia
c) Japan
d) European Union
e) Canada

A

a) United States

c) Japan
d) European Union

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21
Q

According to ICH GCP, an investigator must inform the subject’s primary physician about the subject’s participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.

true
false

A

false

It is recommended…

4.3.3

22
Q

When changing or correcting a CRF, what items do we need to include and ensure (select all that apply)?

a) signed by the PI
b) dated and initialed
c) reported to the sponsor in real time
d) explained
e) correction does not obscure original entry

A

b) dated and initialed

d) explained
e) correction does not obscure original entry

…endorsed by the investigator…

4.9.3

23
Q

Match the CFR number with the subject to which it pertains.

CFR number:

a) 21 CFR Part 11
b) 21 CFR Part 50
c) 21 CFR Part 56
d) 21 CFR Part 312
e) 21 CFR Part 812

CFR subject:

1) Protection of Human Subjects
2) Investigational Device Exemptions
3) Electronic Records; Electronic Signatures
4) Investigational New Drug Application
5) Institutional Review Board

A

a) 3
b) 1
c) 5
d) 4
e) 2

24
Q

Biomedical studies not performed on human subjects are considered nonclinical studies.

true
false

A

true

1.41

25
Q

Source data are contained in:

a) original records
b) certified copies
c) a and b

A

c) a and b

1. 51

26
Q

A trial in which there is no anticipated direct clinical benefit to the subject is called:

a) an experiment
b) a non-therapeutic trial/study
c) a nonclinical trial/study
d) an observational study
e) a pilot trial/study

A

b) a non-therapeutic trial/study

4. 8.13

27
Q

Any change or correction to a CRF should:
(mark all that apply)

a) be dated
b) be initialed
c) be explained
d) be a replacement of the original entry
e) be endorsed by the investigator

A

a, b, c, and e

…should not obscure the original entry…

4.9.3

28
Q

Once the appropriate essential document retainment period has been reached:

a) the investigator may destroy the documents
b) the investigator must transfer retention of the documents to the sponsor
c) the sponsor determines when the documents no longer need to be retained
d) none of the above

A

c) the sponsor determines when the documents no longer need to be retained

It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained.

4.9.5

29
Q

All serious adverse events should be reported immediately and include the subjects’ name.

true
false

A

false

…should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects’ names…

4.11.1

30
Q

A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, including responsibility for the quality and integrity of the trial data.

true
false

A

false

The ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor.

5.2.1

31
Q

Who reports the subject recruitment rate?

a) investigator
b) monitor
c) sponsor

A

b) monitor

5. 18.4(j)

32
Q

Verification that the conduct of the trial is in compliance with the currently approved protocol/amendments(s), with GCP, and with the applicable regulatory requirement is a purpose of ___________.

a) a sponsor’s audit
b) trial monitoring

A

b) trial monitoring

5. 18.1(c)

33
Q

Evaluation of trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements is a purpose of ____________.

a) a sponsor’s audit
b) trial monitoring

A

a) a sponsor’s audit

5. 19.1

34
Q

Regulatory authorities should:

a) automatically receive an audit report
b) not routinely request audit reports
c) seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists
d) seek access to an audit report in the course of legal proceedings

A

b, c, and d

5.19.3(d)

35
Q

Trial master files should be established at the beginning of the trial:

a) at the investigator’s site
b) at the sponsor’s office
c) at the IRB
d) a and b
e) all of the above

A

d) a and b

8. 1

36
Q

A final close-out of a trial can only be done when the monitor has reviewed both investigator and sponsor files and confirmed that all necessary documents are in the appropriate files.

true
false

A

true

8.1

37
Q

Before the clinical phase of the trial commences, which of the following essential documents is not required to be located in the sponsor’s files?

a) informed consent form
b) any other written information
c) advertisement for subject recruitment
d) financial aspects of the trial
e) investigator’s brochure

A

c) advertisement for subject recruitment

8. 2.3

38
Q

Before the clinical phase of the trial commences, which of the following essential documents is required to be located in the investigator’s files?

a) sample of label(s) attached to investigational product container(s)
b) certificate(s) of analysis of investigational product(s) shipped
c) master randomisation list
d) pre-trial monitoring report
e) trial initiation monitoring report

A

e) trial initiation monitoring report

8. 2.20

39
Q

During the clinical conduct of the trial, which of the following essential documents is required to be located in the investigator’s files?

a) audit certificate
b) certificate of analysis for new batches of investigational products
c) final trial close-out monitoring report
d) subject identification code list
e) treatment allocation and decoding documentation

A

d) subject identification code list

8. 3.21

40
Q

During the clinical conduct of the trial, which of the following essential documents is not required to be located in the sponsor’s files?

a) signed informed consent forms
b) source documents
c) subject identification code list
d) subject enrollment log
e) a and d
f) all of the above

A

f) all of the above

  1. 3.12
  2. 3.13
  3. 3.21
  4. 3.22
41
Q

After completion or termination of the trial, which of the following essential documents is required to be located in the investigator’s files?

a) audit certificate
b) final trial close-out monitoring report
c) treatment allocation and decoding documentation
d) completed subject identification code list

A

d) completed subject identification code list

8. 4.3

42
Q

After completion or termination of the trial, which of the following essential documents is not required to be located in the sponsor’s files?

a) completed subject identification code list
b) documentation of investigational product destruction
c) final report by investigator to IRB where required, and where applicable, to the regulatory authorities
d) a and c
e) all of the above

A

d) a and c

  1. 4.3
  2. 4.7
43
Q

A sponsor’s audit is for internal use and therefore a copy is not usually given to the investigator audited.

true
false

A

true

Guide to Clinical Trials
p 449

44
Q

GCPs are consistent with ethical principles put forth in the Declaration of Helsinki. The main purpose(s) of GCP are:

a) to protect human subjects during clinical studies
b) to protect patients who might receive approved products in the future
c) a and b

A

c) a and b

Protecting Study Volunteers in Research
p 49

45
Q

There is no one source of guidance for GCPs.

true
false

A

true

They are embodied within laws, regulations, and guidelines such as:

  • ethical codes
  • IRB and consent regulations
  • guidelines on the obligations of investigators, sponsors, and monitors
  • Code of Federal Regulations pertaining to drugs and devices
  • ICH Guidelines
  • official guidance documents

Protecting Study Volunteers in Research
p 50

46
Q

Compliance with GCPs during clinical trials will ensure that:
(mark all that apply)

a) the rights and safety of human subjects are not compromised
b) appropriately and adequately trained staff manage the study
c) the study is carefully documented
d) protocol is strictly adhered to

A

a, b, c, d

Protecting Study Volunteers in Research
p 50

47
Q

GCPs encompass all aspects of a clinical trial including (but not limited to):
(mark all that apply)

a) obtaining informed consent
b) documenting accurate case histories
c) maintaining complete “paper trails” for all study documents
d) reporting adverse events
e) proper record retention

A

a, b, c, d, e

Protecting Study Volunteers in Research
p 50

48
Q

It is the _______ who must determine whether an application for an IDE or IND is necessary for a specific project.

a) FDA
b) investigator
c) IRB
d) monitor
e) sponsor

A

e) sponsor

Protecting Study Volunteers in Research
p 66

49
Q

The ICH was organized to provide opportunities for standardized regulatory initiatives to be developed with input from:

a) governmental bodies
b) industry representatives
c) both a and b

A

c) both a and b

The CRC’s Guide to Coordinating Clinical Research
p 36

50
Q

Which regions are involved in the ICH?

a) Canada
b) China
c) European Union
d) Japan
e) Switzerland
f) United States

A

c, d, and f

The CRC’s Guide to Coordinating Clinical Research
p 36

51
Q

There are few differences between the FDA and the ICH standards. If a protocol meets ICH guidelines, it will meet FDA requirements.

true
false

A

true

Conducting Clinical Research
p 113

52
Q

The __________ addresses nontherapeutic trials in greater detail and requires more elements in an informed consent than the __________.

a) FDA; ICH
b) ICH; FDA
c) ICH; Nuremberg Code
d) FDA; Nuremburg Code

A

b) ICH; FDA

Conducting Clinical Research
p 113

SOCRA_2015 (15 decks)

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