What does IRB Stand for?
What is Institutional Review Board
The person responsible for the conduct of the clinical trial at a trial site.
Who is the Investigator?
What does ICH stand for?
What is International Conference on Harmonization ?
According to GCP, the investigator "should be qualified by (3 answers)....."?
What is education, training, and experience?
Which document created in 1964 forms the basis of ethical considerations in clinical research?
What is Declaration of Helsinki?
For trial conduct and safety an investigator must have qualified....?
What is staff?
What is the most important consideration when conducting a clinical trial?
What is Subject Safety?
Sites must submit this before the trial start? It shows whether specimens are in range?
What are Normal Values/ranges for lab tests?
This is an agreement between the sponsor and investigator?
What is a signed protocol?