ICH GCP-E6 Flashcards
What does ICH stand for?
International Council for Harmonisation
What is the primary purpose of ICH GCP-E6?
To provide guidelines for Good Clinical Practice in clinical trials.
True or False: GCP guidelines apply only to clinical trials conducted in Europe.
False
Fill in the blank: ICH GCP-E6 provides a framework for ________ in clinical trials.
ethical and scientific quality
Which document outlines the responsibilities of clinical trial sponsors?
The ICH GCP-E6 guidelines
What is the role of the Institutional Review Board (IRB) in clinical trials?
To protect the rights, safety, and well-being of trial participants.
Multiple Choice: Which of the following is NOT a principle of GCP? A) Informed Consent B) Data Integrity C) Profit Maximization
C) Profit Maximization
What is the significance of informed consent in clinical trials?
It ensures that participants are fully aware of the risks and benefits before participating.
True or False: The sponsor is responsible for the overall conduct of a clinical trial.
True
What does the term ‘adverse event’ refer to in clinical trials?
Any unfavorable medical occurrence in a participant during a clinical trial.
Fill in the blank: The ________ is responsible for the scientific design of the trial.
investigator
Which key document must be prepared before starting a clinical trial?
The Clinical Trial Protocol
True or False: GCP guidelines apply to all phases of clinical trials.
True
What is the purpose of monitoring in clinical trials?
To ensure compliance with the protocol and GCP guidelines.
Multiple Choice: Which of the following is NOT a type of clinical trial? A) Phase I B) Phase IV C) Phase X
C) Phase X
What is the role of a Clinical Research Associate (CRA)?
To monitor the progress of clinical trials and ensure compliance with GCP.
Fill in the blank: The ________ must ensure that the trial is conducted in accordance with the protocol.
investigator
What does ‘data integrity’ refer to in the context of GCP?
The accuracy and consistency of data collected during a clinical trial.
True or False: Participants can withdraw from a clinical trial at any time.
True
What is the purpose of a Clinical Study Report (CSR)?
To summarize the trial’s methodology, results, and conclusions.
Which entity is responsible for approving the trial before it begins?
The Institutional Review Board (IRB) or Ethics Committee
Multiple Choice: What is the main focus of GCP guidelines? A) Financial considerations B) Safety and efficacy of interventions C) Marketing strategies
B) Safety and efficacy of interventions
Fill in the blank: ________ is a key principle of GCP that protects human subjects.
Informed consent
What is the significance of the Declaration of Helsinki in relation to GCP?
It provides ethical principles for medical research involving human subjects.
True or False: GCP guidelines are legally binding.
False
What should be done if an adverse event occurs during a trial?
It must be reported according to the protocol and regulatory requirements.
What aspect of clinical trials does the term ‘blinding’ refer to?
The practice of keeping participants unaware of their group assignments to reduce bias.
