Assinale com V (verdadeiro) ou F (falso) as afirmações a seguir sobre Boas Práticas Clínicas.
( ) In relation to trials compliance is adherence to all the trial-related requirements, Good Clinical Practice requirements, and the applicable
regulatory requirements.
regulatory requirements.
( ) Essential document is a permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.
( ) Impartial Witness is an independent body constituted of medical professionals and non-medical members.
( ) If a trial is conducted by a team of individualsat a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
( ) An adverse reaction, the nature or severity of which is not consistent with the applicable product information, is an Unexpected Adverse Drug Reaction.
A sequência correta de preenchimento dos parênteses, de cima para baixo, é
