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Question 1

What does ICH stand for?

Answer 1

International Council for Harmonisation

Question 2

What is the primary purpose of ICH GCP guidelines?

Answer 2

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

Question 3

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

Answer 3

False

Question 4

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

Answer 4

rights

Question 5

What is the significance of informed consent in ICH GCP?

Answer 5

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

Question 6

Which document outlines the protocol for a clinical trial?

Answer 6

Clinical Trial Protocol

Question 7

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

Answer 7

C) Profitability

Question 8

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

Answer 8

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

Question 9

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

Answer 9

False

Question 10

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

Answer 10

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

Question 11

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

Answer 11

sponsor

Question 12

What does the term ‘protocol deviation’ mean?

Answer 12

A departure from the approved clinical trial protocol.

Question 13

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

Answer 13

A) Case Report Form

Question 14

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

Answer 14

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

Question 15

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

Answer 15

True

Question 16

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

Answer 16

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

Question 17

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

Answer 17

investigator

Question 18

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

Answer 18

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

Question 19

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

Answer 19

A) Monitoring trial conduct

Question 20

What is the main focus of ICH GCP regarding data?

Answer 20

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

Question 21

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

Answer 21

False

Question 22

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

Answer 22

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

Question 23

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

Answer 23

transparency

Question 24

What does ‘Good Clinical Practice’ ensure?

Answer 24

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

Question 25

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

Answer 25

A) Duration of the study

Question 26

What is an Investigator's Brochure?

Answer 26

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

Question 27

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

Answer 27

False

Question 28

What does the term 'randomization' mean in clinical trials?

Answer 28

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

Question 29

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

Answer 29

sponsor

Question 30

What should be included in the informed consent form?

Answer 30

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

Question 31

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

Answer 31

C) Marketing strategy

Question 32

What is the importance of auditing in clinical trials?

Answer 32

To ensure compliance with GCP and the trial protocol.

Question 33

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

Answer 33

True

Question 34

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

Answer 34

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

Question 35

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

Answer 35

enrollment

Question 36

What does 'adverse event' mean?

Answer 36

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

Question 37

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

Answer 37

B) To determine safety and efficacy

Question 38

What is a Clinical Trial Agreement (CTA)?

Answer 38

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

Question 39

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

Answer 39

True

Question 40

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

Answer 40

protocol

Question 41

What does the acronym SAE stand for?

Answer 41

Serious Adverse Event

Question 42

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

Answer 42

B) Participant recruitment

Question 43

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

Answer 43

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