EMA《临床试验用计算机化系统验证和确认》.pdf

07 April 2020 EMA/INS/GCP/467532/2019 Inspections Office, Quality and Safety of Medicines Department Notice to sponsors on validation and qualification of computerised systems used in clinical trials Note: This notice should be read in conjunction with Q8 and Q9 from the good clinical practice (GCP) QAs published on the EMA website: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-clinical- practice/qa-good-clinical-practice-gcp Introduction: The integrity, reliability and robustness of data generated in clinical trials, e.g. data submitted to support marketing authorisation applications (MAAs), are essential to regulators. Most clinical trial data supporting MAAs are now collected through computerised data collection tools, e.g. electronic case report forms (eCRFs) and electronic patient reported outcomes (ePROs). In addition, a wide range of computerised media and systems are used in the conduct of a trial, such as safety databases, systems for electronic interactive response technology (eIRT), clinical trial management systems (CTMSs) etc., the use of which will increase in the future. Given recent inspection findings and the implications they have had on the integrity, reliability, robustness and acceptability of data in the context of MAAs, the GCP Inspectors Working Group (IWG) in cooperation with the Committee for Medicinal Products for Human Use (CHMP) sees the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial data. Legal and regulatory background: • Directive 2001/20/EC, Article 2(l) • Directive 2005/28/EC, Article 7 • Regulation (EU) No 536/2014, Recital 51, Articles 2 (30), 2 (31), 47, 71 • ICH Guideline for good clinical practice E6