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3 Flashcards

1
Q

What does ICH stand for?

A

International Council for Harmonisation

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2
Q

What is the primary purpose of ICH GCP guidelines?

A

To ensure that clinical trials are conducted ethically and that data are credible.

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3
Q

True or False: ICH GCP guidelines are legally binding in all countries.

A

False

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4
Q

Fill in the blank: ICH GCP guidelines are designed to protect the ______ of trial participants.

A

rights

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5
Q

What is the significance of informed consent in ICH GCP?

A

It ensures that participants are fully aware of the trial and its implications before agreeing to participate.

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6
Q

Which document outlines the protocol for a clinical trial?

A

Clinical Trial Protocol

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7
Q

Multiple Choice: Which of the following is NOT a key principle of ICH GCP? A) Safety, B) Efficacy, C) Profitability

A

C) Profitability

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8
Q

What is the role of the Institutional Review Board (IRB) in ICH GCP?

A

To review and approve the clinical trial protocol and informed consent forms to ensure participant safety.

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9
Q

True or False: ICH GCP guidelines apply only to drug trials.

A

False

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10
Q

What is a Serious Adverse Event (SAE) according to ICH GCP?

A

An event that results in death, is life-threatening, requires hospitalization, or causes significant disability.

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11
Q

Fill in the blank: The ______ is responsible for ensuring compliance with ICH GCP guidelines during the trial.

A

sponsor

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12
Q

What does the term ‘protocol deviation’ mean?

A

A departure from the approved clinical trial protocol.

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13
Q

Multiple Choice: Which document is essential for keeping track of trial participants? A) Case Report Form, B) Informed Consent Form, C) Safety Report

A

A) Case Report Form

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14
Q

What is the required retention period for trial records according to ICH GCP?

A

At least 2 years after the last marketing application approval or after the trial’s completion.

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15
Q

True or False: GCP training is mandatory for all personnel involved in a clinical trial.

A

True

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16
Q

What does the term ‘blinding’ refer to in clinical trials?

A

A method used to prevent bias by keeping study participants and/or researchers unaware of group assignments.

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17
Q

Fill in the blank: The ______ must ensure that the trial is conducted according to GCP guidelines.

A

investigator

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18
Q

What is the purpose of a Data Monitoring Committee (DMC)?

A

To oversee the safety and efficacy of the trial and to recommend continuation or termination of the trial.

19
Q

Multiple Choice: Which of the following is a key responsibility of the sponsor in ICH GCP? A) Monitoring trial conduct, B) Performing laboratory tests, C) Recruiting participants

A

A) Monitoring trial conduct

20
Q

What is the main focus of ICH GCP regarding data?

A

To ensure that data are accurate, reliable, and verifiable.

21
Q

True or False: Investigators can modify the trial protocol at any time without approval.

A

False

22
Q

What is the role of the Clinical Research Associate (CRA)?

A

To monitor the trial sites and ensure compliance with the protocol and GCP guidelines.

23
Q

Fill in the blank: ICH GCP guidelines emphasize the importance of ______ in clinical trials.

A

transparency

24
Q

What does ‘Good Clinical Practice’ ensure?

A

The quality and integrity of clinical trial data and the protection of participants’ rights.

25
Q

Multiple Choice: Which of the following is a critical element of informed consent? A) Duration of the study, B) Sponsor’s profit, C) Researcher’s credentials

A

A) Duration of the study

26
Q

What is an Investigator’s Brochure?

A

A document that provides the investigator with the necessary information about the investigational product.

27
Q

True or False: ICH GCP guidelines apply only to trials conducted in developed countries.

A

False

28
Q

What does the term ‘randomization’ mean in clinical trials?

A

The process of assigning trial participants to different groups by chance.

29
Q

Fill in the blank: The ______ is responsible for reporting all SAEs to the regulatory authorities.

A

sponsor

30
Q

What should be included in the informed consent form?

A

Purpose of the study, risks, benefits, and the right to withdraw.

31
Q

Multiple Choice: Which of the following is NOT a component of GCP? A) Study design, B) Data analysis, C) Marketing strategy

A

C) Marketing strategy

32
Q

What is the importance of auditing in clinical trials?

A

To ensure compliance with GCP and the trial protocol.

33
Q

True or False: The sponsor must ensure that the trial is conducted in compliance with local regulations.

A

True

34
Q

What is the role of the regulatory authority in clinical trials?

A

To review and approve clinical trial applications and monitor compliance with regulations.

35
Q

Fill in the blank: Informed consent must be obtained before ______ in a clinical trial.

A

enrollment

36
Q

What does ‘adverse event’ mean?

A

Any undesirable experience associated with the use of a medical product in a patient.

37
Q

Multiple Choice: What is the primary goal of a clinical trial? A) To make a profit, B) To determine safety and efficacy, C) To develop marketing strategies

A

B) To determine safety and efficacy

38
Q

What is a Clinical Trial Agreement (CTA)?

A

A contract between the sponsor and the investigator outlining the terms of the trial.

39
Q

True or False: Participants can be compensated for their involvement in a clinical trial.

A

True

40
Q

Fill in the blank: The ______ must provide a clear rationale for the trial’s design.

A

protocol

41
Q

What does the acronym SAE stand for?

A

Serious Adverse Event

42
Q

Multiple Choice: Which of the following is a key responsibility of the investigator? A) Data analysis, B) Participant recruitment, C) Marketing the drug

A

B) Participant recruitment

43
Q

What is the purpose of the final report in a clinical trial?

A

To summarize the study results and provide conclusions based on the data collected.

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