UK MHRA and US FDA Tackle Challenging Data Integrity

On 1 September 2021 the UK MHRA Inspectorate published the white paper on 2020 MHRA and FDA joint Good Clinical Practice (GCP) symposium.

With the globalization of clinical trials, regulators have increased collaboration to evaluate the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint Good Clinical Practice (GCP) symposium of the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency provided the agencies’ perspectives on the challenges in ensuring data quality in novel clinical trial designs and the importance of the management and documentation of protocol deviations, sponsor oversight of clinical trials, and use of electronic source data, including electronic health records. The paper discusses both agencies’ considerations on data integrity topics, from decentralized clinical trials, adaptive design trials and management of protocol deviations to real-world data. It also discusses the impact of the coronavirus disease 2019 (COVID-19) pandemic on clinical trial conduct and underscores the importance of well-designed, resilient, and adaptable systems for GCP compliance and data integrity.

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