Practice Questions Flashcards
Which countries participate/accept GCP?
ICH GCP Guideline Integrated Addendum provides a unified standard for the European Union, Japan, the United States, Canada and Switzerland to facilitate the mutual acceptance of data from clinical trials y the regulatory authorities in these jurisdictions
When do unexpected serious suspected adverse reactions need to be reported? (Not life threatening)
ASAP but no later than within 15 calendar days following the sponsor’s initial receipt of the information
When do observations from animal studies that suggest significant risks to human subjects need to be reported for an IND?
ASAP but no later than within 15 calendar days following the sponsor’s initial receipt of the information
When do unexpected fatal or life threatening suspected adverse reactions need to be reported?
ASAP but no later than within 7 calendar days following the sponsor’s initial receipt of the information
When does an IND safety report follow-up need to be submitted?
Within 8 calendar days following the initial report
Emergency use of an IND/IDE need to be reported within…
5 days
How often much the IRB renew its registration?
Every 3 years
What is the process for obtaining assent for children who are wards of the state?
They are required to have an advocate
What is GCP?
Good clinical practice is an international ethical and scientific quality standard for seigning, conducting, recording and reporting trials that involve the participation of human subjects.
What does compliance with GCP standard ensure?
Provides public assurance that the rights, safety, and well-being of trail subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data is credible.
Who assisted with developing the ICH GCP?
The guidance was developed with consideration of the current GCP of the European Union, Japan and the United States. Additionally, Australia, Canada, the Nordic countries and the World Health Organization.
