EMA - FDA Guidance on electronic data in clinical trials

The EMA has released its final guideline on computerised systems and electronic data in clinical trials.

The EMA has developed this guideline as computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly in the last few years from electronic case report forms (eCRF), electronic patient reported outcomes (ePROs) to various wearable devices used to continuously monitor trial participants for clinically relevant parameters and ultimately to the use of artificial intelligence (AI). Hence, there is a need to provide guidance to all stakeholders involved in clinical trials reflective of these changes in data types and trial types on the use of computerised systems and on the collection of electronic data, as this is important to ensure the quality and reliability of trial data, as well as the rights, dignity, safety and wellbeing of the trial participants. This would ultimately contribute to a robust decision-making process based on such clinical data.
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 guideline is expected to come into effect 6 months after publication, i.e. on 10 September 2023.

Reference link: EMA Guideline on computerised systems and electronic data in clinical trials

The FDA is announcing the draft guidance for industry entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.” This FDA draft guidance is of interest to Gilead and Kite’s clinical development involving the use of electronic systems. Internal stakeholders and SMEs will be contacted regarding this opportunity to comment and work with our trade organizations. FDA’s deadline to comment is May 15, 2023.

The draft guidance aims to:

1. Update recommendations for applying and implementing data integrity and data security controls, including the use of audit trails and the protection of records.
2. Provide additional recommendations on the risk-based approach to validation of electronic systems described in the 2003 guidance for industry "Part 11, Electronic Records; Electronic Signatures — Scope and Application."
3. Facilitate the use of electronic systems, electronic records, and electronic signatures to improve the quality and efficiency of clinical investigations.

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Link to FDA draft guidance

FDA Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations_Questions and Answers Mar 2023 draft for comments.pdf