Scientific Poster , Translational Pharmaceutics , Clinical Trial Manufacturing , First-in-Human

Why Archiving is a Crucial Part of Any Clinical Trial

17 May 2022
Overview

One of the crucial requirements of the principles of Good Clinical Practice (GCP) is the need to ensure the integrity and secure retention of clinical trial documents and records for a period of time determined by legal, country regulations and business requirements. Essential documents serve to demonstrate the compliance of the investigator, sponsor, and Clinical Research Organization (CRO) with the standards of GCP, protocol, procedures and with all applicable regulatory agencies.

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Date
17 May 2022