ICH GCP-E6

Question 1

What does ICH stand for?

Answer 1

International Council for Harmonisation

Question 2

What is the primary purpose of ICH GCP-E6?

Answer 2

To provide guidelines for Good Clinical Practice in clinical trials.

Question 3

True or False: GCP guidelines apply only to clinical trials conducted in Europe.

Answer 3

False

Question 4

Fill in the blank: ICH GCP-E6 provides a framework for ________ in clinical trials.

Answer 4

ethical and scientific quality

Question 5

Which document outlines the responsibilities of clinical trial sponsors?

Answer 5

The ICH GCP-E6 guidelines

Question 6

What is the role of the Institutional Review Board (IRB) in clinical trials?

Answer 6

To protect the rights, safety, and well-being of trial participants.

Question 7

Multiple Choice: Which of the following is NOT a principle of GCP? A) Informed Consent B) Data Integrity C) Profit Maximization

Answer 7

C) Profit Maximization

Question 8

What is the significance of informed consent in clinical trials?

Answer 8

It ensures that participants are fully aware of the risks and benefits before participating.

Question 9

True or False: The sponsor is responsible for the overall conduct of a clinical trial.

Answer 9

True

Question 10

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

Answer 10

Any unfavorable medical occurrence in a participant during a clinical trial.

Question 11

Fill in the blank: The ________ is responsible for the scientific design of the trial.

Answer 11

investigator

Question 12

Which key document must be prepared before starting a clinical trial?

Answer 12

The Clinical Trial Protocol

Question 13

True or False: GCP guidelines apply to all phases of clinical trials.

Answer 13

True

Question 14

What is the purpose of monitoring in clinical trials?

Answer 14

To ensure compliance with the protocol and GCP guidelines.

Question 15

Multiple Choice: Which of the following is NOT a type of clinical trial? A) Phase I B) Phase IV C) Phase X

Answer 15

C) Phase X

Question 16

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

Answer 16

To monitor the progress of clinical trials and ensure compliance with GCP.

Question 17

Fill in the blank: The ________ must ensure that the trial is conducted in accordance with the protocol.

Answer 17

investigator

Question 18

What does ‘data integrity’ refer to in the context of GCP?

Answer 18

The accuracy and consistency of data collected during a clinical trial.

Question 19

True or False: Participants can withdraw from a clinical trial at any time.

Answer 19

True

Question 20

What is the purpose of a Clinical Study Report (CSR)?

Answer 20

To summarize the trial’s methodology, results, and conclusions.

Question 21

Which entity is responsible for approving the trial before it begins?

Answer 21

The Institutional Review Board (IRB) or Ethics Committee

Question 22

Multiple Choice: What is the main focus of GCP guidelines? A) Financial considerations B) Safety and efficacy of interventions C) Marketing strategies

Answer 22

B) Safety and efficacy of interventions

Question 23

Fill in the blank: ________ is a key principle of GCP that protects human subjects.

Answer 23

Informed consent

Question 24

What is the significance of the Declaration of Helsinki in relation to GCP?

Answer 24

It provides ethical principles for medical research involving human subjects.

Question 25

True or False: GCP guidelines are legally binding.

Answer 25

False

Question 26

What should be done if an adverse event occurs during a trial?

Answer 26

It must be reported according to the protocol and regulatory requirements.

Question 27

What aspect of clinical trials does the term 'blinding' refer to?

Answer 27

The practice of keeping participants unaware of their group assignments to reduce bias.