The EMA published the final guideline on computerised systems and electronic data in clinical trials.
This guideline will describe some generally applicable principles and definition of key concepts. It also covers requirements and expectations for computerised systems, including validation, user management, security, and electronic data for the data life cycle. Requirements and expectations are also covered related to specific types of systems, processes, and data.
The current guideline has 52 pages – the draft version had 47 pages. But there have been no major changes between the draft and the final version.
Download it here on the EMA website: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-electronic-data-clinical-trials_en.pdf
Here is the download link to the US-FDA Guidance for Industry – Computerized Systems Used in Clinical Investigations from 2007: LINK
Both guidelines are comparable, however the US-FDA guidance applies to medicinal products and medical devices (ref. 21 CFR 312.62(b) and 812.140(b)) and both guidelines refer to ICH E6.
The EMA GCP regulations and directives lacked on clearly defined requirements for computerized systems, and useful GMP regulations (e.g. Annex 11) were not really fitting to GCP processes (e.g. data entry, batch certification), this EMA guideline is highly appreciated and serves as a good basis for GCP computer system validation.
Read more also at the EMA Q&A GCP section: LINK
1. What are the roles and requirements for the study subject record (medical record) and related source documents in the context of a clinical trial?
2. What should be considered when transferring copies of medical records to clinical trials sponsors or their service providers? Rev. March 2022