Clinical Trials: Ethics and GCP Principles

What does 'informed consent' in GCP primarily ensure?

Which criteria must be met for a clinical trial to be considered ethical?

Why is blinding used in clinical trials?

What is the significance of the Declaration of Helsinki for clinical trials?

What is essential for the IRB/IEC when determining the composition of its members?

Which responsibility does the IRB/IEC have regarding trial subjects and payments?

What role does the investigator have in the IRB/IEC meetings?

What is a required minimum composition of members for the IRB/IEC?

What is the purpose of inviting non-members with expertise to the IRB/IEC?

What agreement must the investigator/institution give to conduct the trial?

Which of the following is NOT a responsibility of the investigator as per the agreement with the sponsor?

What must the sponsor do regarding insurance or indemnification?

What is the primary role of the principal investigator in a clinical trial?

What is the purpose of a protocol amendment in a clinical trial?

What types of adverse drug reactions (ADRs) must the sponsor expedite reporting for?

'Informed consent' in GCP primarily ensures participant understanding.
Scientific validity is a key criterion for a clinical trial to be considered ethical.
Blinding is used in clinical trials to prevent bias.
The Declaration of Helsinki guides ethical principles for clinical trials.
For IRB/IEC composition, at least one member should be independent of the institution/trial site.
The IRB/IEC has the responsibility to evaluate if payment amounts to trial subjects could lead to undue influence.
An investigator in IRB/IEC meetings may provide information but should not contribute to deliberations.
The IRB/IEC requires a minimum composition of at least five members.
Non-members with expertise are invited to the IRB/IEC to gain specific insights that enhance the review process.
The investigator/institution must agree to compliance with Good Clinical Practice and regulatory requirements to conduct the trial.
Providing financial support to subjects is NOT a responsibility of the investigator as per the agreement with the sponsor.
The sponsor must indemnify the investigator for all trial-related claims regarding insurance or indemnification.
The primary role of the principal investigator in a clinical trial is to lead the team of individuals at the trial site.
A protocol amendment in a clinical trial is to describe changes or clarifications to the original protocol.
Sponsors must expedite reporting for serious and unexpected adverse drug reactions (ADRs).