What are the roles and requirements for the study subject record (medical record) and related source documents in the context of a clinical trial?Ģ. Read more also at the EMA Q&A GCP section: LINKġ. data entry, batch certification), this EMA guideline is highly appreciated and serves as a good basis for GCP computer system validation. Annex 11) were not really fitting to GCP processes (e.g. The EMA GCP regulations and directives lacked on clearly defined requirements for computerized systems, and useful GMP regulations (e.g. Here is the download link to the US-FDA Guidance for Industry – Computerized Systems Used in Clinical Investigations from 2007: LINKīoth guidelines are comparable, however the US-FDA guidance applies to medicinal products and medical devices (ref. But there have been no major changes between the draft and the final version. The current guideline has 52 pages – the draft version had 47 pages. Requirements and expectations are also covered related to specific types of systems, processes, and data. It also covers requirements and expectations for computerised systems, including validation, user management, security, and electronic data for the data life cycle. This guideline will describe some generally applicable principles and definition of key concepts. The EMA published the final guideline on computerised systems and electronic data in clinical trials.
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