The introduction of a section dedicated to data governance in the European good clinical practice (GCP) guidance provides much-needed clarity.

In what she said was one of the most significant updates to the International Council for Harmonisation (ICH) E6 GCP (revision three) guidelines, Silvia Perez, director of clinical quality compliance at AstraZeneca said that there has been a need for clarity on data governance.

The new guidance is available to view as a draft document, with implementation expected in August/September 2024. At the time of implementation, the draft version of Annexe two of the document is expected to be released for comments.

Speaking at Arena International’s Outsourcing in Clinical Trials (OCT) Europe 2024 conference in Barcelona, Perez said: “The main scope of this guidance is that clinical trials should be designed to protect the right safety and wellbeing of participants and ensure the reliability of the results. This guidance is recommended to have a careful evaluation of the scientific objectives in the clinical trials and the risks associated with them, focusing on activities that are critical to achieving the trial objectives.”

Perez spoke about how there are four key processes in the data governance section. This includes processes to ensure the protection of participant data, processes for managing computer systems, processes to safeguard elements such as randomisation, dosing escalation and integrity of the blind, and processes to support key decision making which includes data finalisation, unblinding and changes in trial design.

The data governance section breaks down where the responsibility lies for both the sponsor and investigator. Although there are many similarities, the key differences are that the investigator is only responsible for data during their involvement while the sponsor is responsible for the full life cycle of the data and the investigator must ensure ‘accuracy, completeness, legibility and timeliness of data’ while the sponsor must ensure that the quality control is applied at the relevant stages to ensure reliability of data.

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Perez went on to explain how the data life cycle looks from the moment of data capture to the finalisation of data before analysis. This cycle includes metadata collected in the audit trials.

Perez discussed other changes beyond the data governance, including expansions of the sections about the principles of ICH, investigators, and sponsors.

The main focuses in the revision are on the protection of patients, evaluation of objectives and risks to ensure efficiency, quality of trial design and trial processes and strategies to mitigate risk. There is also a focus on the use of technology in all areas of clinical trials.