MHRA and FDA release Joint Paper on Data Integrity in Clinical Trials

Recommendation

8/9 October 2020

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MHRA and FDA GCP Inspectors have released a joint paper on data integrity in global clinical trials. The paper is published in the Journal of Clinical Pharmacology and Therapeutics.

How to ensure data Integrity in clinical trials

Concerns with data reliability could lead to rejection of data used in submissions, but it can also pose significant safety risks, the agencies say.

According to the MHRA, the joint paper describes

• the need for robust processes to manage data,
• issues that impact data integrity, such as audit trails, maintaining the study blind and general data management practices,
• case studies where MHRA and FDA have raised concerns during GCP inspections.

In addition, the agencies are working towards a programme of collaborative and joint inspections.

The MHRA notes that a further joint paper with the FDA is expected to be released in the near future. The second publication will discuss topics like sponsor oversight, electronic source documents, protocol deviations and data quality in novel clinical trial designs.

More information can be found on MHRA´s Blog entitled MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'.