Auditing in brief
Between brilliant research concepts and high-quality results, many meticulous steps are taken. Whereas monitoring is a quality control function, through which study conduct is routinely assessed at every step of a given trial, auditing serves a quality assurance function: the independent, top-down, methodical evaluation of trial conduct, and the underlying processes and systems.
Thanks to the scrutiny of qualified auditors, systems improve and trials become more efficient and streamlined. Auditors assess whether a system is lawful and serves its purpose. Furthermore, they check if trial activities are conducted following the sponsor’s Standard Operating Procedures, Good Clinical Practice, and the applicable regulatory requirements, and if data is recorded, analysed, and accurately reported according to the protocol. The rigour of auditing improves the quality and credibility of data produced, potentially helping it reach and benefit the public.
Would you like to know how the experts in the Auditing Platform are channeling their efforts? For more information, consult the fact sheet below.