In October 2024, the FDA released a document titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations. This guidance marks a much-appreciated clarification of the staple August 2003 document many refer to as Part 11: “Part 11, Electronic Records; Electronic Signatures — Scope and Application.”
While both documents aim to ensure the integrity and security of electronic records and signatures, the supplemental 2024 guidance introduces several new elements that reflect the advancements in technology and the specific needs of clinical investigations, providing tailored advice and clarifications that are directly relevant to the GCP (Good Clinical Practices) space.
Highlighted below are such notable elements that make the 2024 guidance a must read for people operating the clinical research space.
Q&A Format
The new guidance adopts a detailed Q&A format, which is a departure from the more general narrative style of Part 11. This format allows for a more practical and user-friendly approach, addressing specific scenarios and questions that stakeholders in clinical trials might encounter. It also identifies key compliance issues that have either been trending or have seen significant increase spanning the past few years.
This helps to demystify what could be conceived as complex regulatory requirements and provides actionable guidance around those specific questions.
Roles and Responsibilities
The 2024 guidance outlines the roles and responsibilities of sponsors, investigators, and other stakeholders in clinical investigations in relation with the use of electronic systems, records and signatures. It provides clarity on the expectations and obligations of each party, helping to ensure that all stakeholders are aligned.
Comprehensive Compliance Guidance
The 2024 document offers a comprehensive guidance on compliance with Part 11 requirements, validation of electronic systems used and deployed in clinical investigations, and managing external IT service providers and services, all within the context of clinical investigations.
This includes recommendations on how to achieve and maintain compliance, as well as practical tips for implementing effective electronic systems and controls.
Conclusion
The FDA’s 2024 guidance on electronic systems, records, and signatures in clinical investigations represents a noticeable step forward in ensuring the integrity and security of electronic data in this field. By answering specific questions of the GCP space in relation with the use of electronic systems, records and signatures, it has simplified the adequate application of P11 in that space.
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