Unleashing the Power of Technology in Clinical Trials: FDA’s Latest Guidance on Electronic Systems, Records and Signatures
The U.S. Food and Drug Administration (FDA) released a draft guidance on March 15, 2023, titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (2023 Draft Guidance)”.
This draft updates the earlier 2017 draft guidance (Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 Part 11 – Questions and Answers) which is based on the 2003 FDA guidance (recommendations on electronic records and signatures under CFR Part 11).
The update to the guidance has brought important changes to the way technology is being utilized in the clinical trial field, and FDA indicates that, when finalized, it will supersede its 2007 guidance (computerized systems in clinical trials).
Why is this guidance being updated?
The FDA recognizes that the use of electronic technologies in clinical trials has evolved significantly over the past two decades. As technology has continued to advance, new tools and approaches have emerged that are transforming the way clinical trials are conducted. To keep up with these changes, the FDA has determined that it is necessary to update its guidance on the use of electronic technologies in clinical trials.
What is the goal of this draft guidance?
The primary goal is to provide updated recommendations and best practices for the use of electronic systems, electronic data, and electronic signatures in clinical investigations. When finalized, this draft guidance is intended to represent FDA’s current position on electronic systems, records, and signatures in clinical investigations.
Who is this guidance of interest to?
This guidance will be of interest to contracting agencies, clinical investigators, institutional review boards (IRBs), and contract research organizations (CROs) that use electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs.
What are the updates of this draft guidance?
The updates in this draft guidance reflect the rapid advancements in technology. It recognizes that electronic systems and technologies are now being used and managed in novel ways that were not envisaged at the time of the previous draft guidance, released in 2017. Consequently, the changes implemented include:
- Information technology (IT) added as a new concept
- Digital health technology (DHT) included as a new concept
- Revisions of risk-based approach for validation
- Expanded Glossary
In the following section, we will delve into the specifics of the changes and improvements made in this draft guidance.
What are the details of the changes?
The updated guidance recognizes the increasingly prevalent use of Information Technology Service Providers (ITSPs) as part of clinical investigations and provides recommendations for regulated entities on how to ensure the data integrity and data security safeguards that are relevant to the service provided by the ITSP. Specifically, the guidance recommends that regulated entities enter into service level agreements with ITSPs, evaluate and select ITSPs based on their ability to provide the necessary safeguards, document quality and risk management procedures related to the ITSP, and record ongoing oversight of the ITSP.
The updated draft guidance takes into account the technological advancements made since 2017, including the use and applicability of audit trails, biometric and multi-factor authentication, digital health technologies (DHTs) and remote applications, metadata, and signatures drawn with a finger or electronic stylus on an electronic system.
The recommendations regarding these technologies aim to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
Additionally, the updated draft guidance does include revisions to the risk-based approach for validation of electronic systems, particularly in relation to customized systems. The guidance recommends that sponsors review a vendor’s standard operating procedures (SOPs), system and software development life cycle model, validation documentation, and change control procedures, and that user acceptance testing (UAT) is performed to ensure the customized system fulfills the intended purpose.
These recommendations aim to ensure that customized electronic systems used in clinical investigations are validated to a level appropriate to their intended use and potential impact on data integrity, patient safety, and product quality.
Lastly, the updated guidance includes an expanded glossary of terms related to electronic technologies in clinical investigations, such as audit trails, certified copies, DHTs, ITSPs, metadata, and service level agreements. This expanded glossary aims to provide clarity and consistency in the use of terminology related to electronic technologies in clinical investigations.
What conclusions can be drawn?
The recommendations aim to ensure the integrity and reliability of electronic records and signatures and facilitate the adoption of technological advancements in clinical investigations, while also providing clarity and consistency in the use of terminology related to electronic technologies in clinical investigations.
In conclusion, the FDA emphasizes the significance of comprehending the changing applications of electronic records, electronic systems, and electronic signatures in clinical investigations. This understanding is crucial for the FDA to ensure the accuracy, security, and trustworthiness of the data provided in marketing applications or submissions.
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