Considere as afirmações a seguir sobre Boas Práticas Clínicas.
I - The Investigator’s Brochure is a compilation of the clinical and nonclinical data on the investigational product that are relevant to the study of the product in human subjects.
II - Only important changes or corrections to a Case Report Form (CRF) should be dated, initialed, and explained and should not obscure the original entry.
III - Monitors should be appropriately trained and should have adequate scientific and/or clinical knowledge. However, a monitor’s qualifications should not be documented.
IV - The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design.
Quais estão corretas?
