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USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A

A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers" was released yesterday (15th March 2023).

In this draft guidance, recommendations are provided regarding the use of electronic systems, electronic records, and electronic signatures in clinical investigations of new animal drugs, medical products, and tobacco products.

As part of the guidance, FDA provides recommendations about requirements, including 21 CFR part 11, which stipulates that electronic systems, electronic records, and electronic signatures are trustworthy, dependable, and generally equal to paper records and handwritten signatures.

In short this guidance:

  • aims to update recommendations for data integrity and data security controls in electronic systems used in clinical investigations.

  • provides additional recommendations on the risk-based approach to the validation of electronic systems.

  • aims to facilitate the use of electronic systems, records, and signatures to improve the quality and efficiency of clinical investigations.

Furthermore, this guide discusses how part 11 requirements apply to electronic systems and information technology (IT) services for creating, modifying, maintaining, archiving, retrieving, or transmitting electronic records, as well as how digital health technology (DHT) can be used to acquire data remotely in clinical trials.

There was also one more guidance finalized and released yesterday, which is "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act" which provide requirements for the tracing, verification, and identification of certain drug products distributed in the United States.


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