What is the primary goal of Good Clinical Practice (GCP)?
GCP ensures the protection of human rights and the integrity of clinical trial data.
Which guideline defines the standard for clinical trials globally?
ICH E6 (R2) outlines international GCP standards for ethical and scientific quality.
Who is ultimately responsible for ensuring GCP compliance at a trial site?
The principal investigator oversees the conduct of the trial and compliance with GCP guidelines.
Which GCP document outlines roles and responsibilities of clinical trial stakeholders?
The ICH GCP guideline describes responsibilities of sponsors, investigators, and IRBs.
What is required before initiating a clinical trial under GCP?
IRB approval and informed consent ensure the trial meets ethical and legal standards.
Which element is NOT part of a standard GCP training program?
GCP training focuses on ethical conduct, roles, safety, and quality standards.
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Why is it important to follow standard operating procedures (SOPs)?
SOPs standardize practices to ensure consistency and compliance across the trial.
How often should GCP training be updated for clinical staff?
Regular training ensures that staff remain compliant with current GCP standards.
What should be done if a GCP violation occurs during a trial?
All GCP violations must be documented, reported, and addressed to maintain trial integrity.