According to ich e6 an i - Study guides, Class notes & Summaries

Q 1 Good Clinical Practices (GCP) is an international, ethical, and scientific quality standard for conducting, documenting, and reporting human trials to provide assurance that the rights, safety, and well being of trial subjects are protected. Where are GCP regulations/guidance found in? ICH E6 21 CFR part 56 21 CFR part 50 21 CFR part 46 NOT 21 CFR part 96 What is one of the principles GCP according to of ICH (international conference on Harmonization) guiedlines? - Records m...

Biometrics A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature An electronic signature based upon cry...