3 Flashcards
What does ICH stand for?
International Council for Harmonisation
What is the primary purpose of ICH GCP guidelines?
To ensure that clinical trials are conducted ethically and that data are credible.
True or False: ICH GCP guidelines are legally binding in all countries.
False
Fill in the blank: ICH GCP guidelines are designed to protect the ______ of trial participants.
rights
What is the significance of informed consent in ICH GCP?
It ensures that participants are fully aware of the trial and its implications before agreeing to participate.
Which document outlines the protocol for a clinical trial?
Clinical Trial Protocol
Multiple Choice: Which of the following is NOT a key principle of ICH GCP? A) Safety, B) Efficacy, C) Profitability
C) Profitability
What is the role of the Institutional Review Board (IRB) in ICH GCP?
To review and approve the clinical trial protocol and informed consent forms to ensure participant safety.
True or False: ICH GCP guidelines apply only to drug trials.
False
What is a Serious Adverse Event (SAE) according to ICH GCP?
An event that results in death, is life-threatening, requires hospitalization, or causes significant disability.
Fill in the blank: The ______ is responsible for ensuring compliance with ICH GCP guidelines during the trial.
sponsor
What does the term ‘protocol deviation’ mean?
A departure from the approved clinical trial protocol.
Multiple Choice: Which document is essential for keeping track of trial participants? A) Case Report Form, B) Informed Consent Form, C) Safety Report
A) Case Report Form
What is the required retention period for trial records according to ICH GCP?
At least 2 years after the last marketing application approval or after the trial’s completion.
True or False: GCP training is mandatory for all personnel involved in a clinical trial.
True
What does the term ‘blinding’ refer to in clinical trials?
A method used to prevent bias by keeping study participants and/or researchers unaware of group assignments.
Fill in the blank: The ______ must ensure that the trial is conducted according to GCP guidelines.
investigator
What is the purpose of a Data Monitoring Committee (DMC)?
To oversee the safety and efficacy of the trial and to recommend continuation or termination of the trial.
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) Monitoring trial conduct
What is the main focus of ICH GCP regarding data?
To ensure that data are accurate, reliable, and verifiable.
True or False: Investigators can modify the trial protocol at any time without approval.
False
What is the role of the Clinical Research Associate (CRA)?
To monitor the trial sites and ensure compliance with the protocol and GCP guidelines.
Fill in the blank: ICH GCP guidelines emphasize the importance of ______ in clinical trials.
transparency
What does ‘Good Clinical Practice’ ensure?
The quality and integrity of clinical trial data and the protection of participants’ rights.
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) Duration of the study
What is an Investigator’s Brochure?
A document that provides the investigator with the necessary information about the investigational product.
True or False: ICH GCP guidelines apply only to trials conducted in developed countries.
False
What does the term ‘randomization’ mean in clinical trials?
The process of assigning trial participants to different groups by chance.
Fill in the blank: The ______ is responsible for reporting all SAEs to the regulatory authorities.
sponsor
What should be included in the informed consent form?
Purpose of the study, risks, benefits, and the right to withdraw.
Multiple Choice: Which of the following is NOT a component of GCP? A) Study design, B) Data analysis, C) Marketing strategy
C) Marketing strategy
What is the importance of auditing in clinical trials?
To ensure compliance with GCP and the trial protocol.
True or False: The sponsor must ensure that the trial is conducted in compliance with local regulations.
True
What is the role of the regulatory authority in clinical trials?
To review and approve clinical trial applications and monitor compliance with regulations.
Fill in the blank: Informed consent must be obtained before ______ in a clinical trial.
enrollment
What does ‘adverse event’ mean?
Any undesirable experience associated with the use of a medical product in a patient.
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
B) To determine safety and efficacy
What is a Clinical Trial Agreement (CTA)?
A contract between the sponsor and the investigator outlining the terms of the trial.
True or False: Participants can be compensated for their involvement in a clinical trial.
True
Fill in the blank: The ______ must provide a clear rationale for the trial’s design.
protocol
What does the acronym SAE stand for?
Serious Adverse Event
Multiple Choice: Which of the following is a key responsibility of the investigator? A) Data analysis, B) Participant recruitment, C) Marketing the drug
B) Participant recruitment
What is the purpose of the final report in a clinical trial?
To summarize the study results and provide conclusions based on the data collected.
