audit

systematic examination of activities and documents related to a clinical investigation (3.8) performed by (an) independent (3.26) person(s), to determine whether these activities were conducted, and the data recorded, analysed and accurately reported, according to the CIP, standard operating procedures, this document and applicable regulatory requirements

систематичнипреглед активности и докумената у вези са клиничким испитивањем (3.8), извршен од стране независне (3.26) особе (особа) ради утврђивања да ли су ове активности спроведене, и да ли су подаци забележени, анализирани и да ли се о њима тачно извештавало, у складу са CIP-ом, стандардним оперативним процедурама, овим документом и применљивим захтевима прописа