The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers". This guidance aims to clarify the agency's expectations for the use of electronic systems in clinical trials, ensuring data integrity, transparency, and compliance with applicable regulatory standards.
Electronic Records: Electronic records used in clinical investigations that fall under the scope of part 11 requirements include:
• Records needed for FDA to reconstruct a clinical investigation that are maintained and retained under predicate rules in electronic form in place of paper form or where the electronic record is relied on to perform regulated activities
• Records submitted to FDA in electronic form under predicate rules, even if such records are not specifically identified in FDA regulations
Electronic Signatures: An electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.
Electronic Systems: Systems that capture, store, manipulate, or transmit clinical data electronically. These include electronic data capture (EDC) systems, clinical trial management systems (CTMS), eConsent platforms, and eSource systems.
In this guidance sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties are informed about how electronic systems, electronic records, and electronic signatures can be used in clinical trials of foods, medical products, tobacco products, and new animal drugs. The guidance provides recommendations regarding the requirements in our regulations, which states that FDA regards electronic systems, electronic records, and electronic signatures as trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
This guidance also addresses the applicability of part 11 requirements for electronic systems and information technology (IT) services used to create, modify, maintain, archive, retrieve, or transmit an electronic record as well as for the use of digital health technology (DHT) to remotely acquire data in a clinical investigation.
The increased use of electronic systems in clinical investigations has created new opportunities for improving efficiency, data quality, and patient engagement. However, it has also introduced challenges regarding data management, system validation, and regulatory compliance. This guidance is necessary to help the clinical research community understand how to apply existing regulations to modern electronic tools used in trials.
Electronic records can be retained in various ways; for example, using electronic storage devices or cloud computing. Regulated entities are required to ensure the integrity and confidentiality of data, as well as to preserve the meaning of the records. All electronic records and their associated metadata should be preserved securely and traceable.
For more details and to access the full guidance document, refer to the FDA's website.
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