12/19/2024
Photo by Markus Spiske on Unsplash
In October 2024, The Food and Drug Administration (FDA) released a final guidance: “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers”. It is intended for sponsors, principal investigators, institutional review boards (IRB), contracted research organizations (CRO) (all of which are considered regulated entities) and other interested clinical trial stakeholders that use electronic records and systems. The guidance provides recommendations regarding the requirements of 21 CFR part 11 and expands on the existing guidance “Part 11, Electronic Records; Electronic Signatures — Scope and Application (August 2003)” as the FDA acknowledges the advances in technology since 2003. Following a brief introduction and background, the guidance goes into a Q&A on the major topics of electronic records and systems in clinical trials.
Electronic Records (ER): ERs used in clinical trials that fall under part 11 requirements include records needed for FDA reconstruction of a trial and records submitted to the FDA in electronic form (both are under the predicate rule).
Should regulated entities maintain and retain a certified copy of clinical investigation electronic records?
How should regulated entities retain electronic records from a clinical investigation?
Are electronic communication methods (e.g., email systems or text messages) addressed by 21 CFR part 11?
Electronic Systems (ES) Deployed by Regulated Entities (RE): Regarding creating modifying, archiving, retrieving, and transmitting trial records, REs should ensure their deployed ESs are fit for purpose and are implemented in a way that protects patient safety and upholds data integrity.
What should be considered when using a risk-based approach for validation of electronic systems deployed in clinical investigations?
What will be FDA’s focus during inspections of clinical investigators for electronic systems that fall under the scope of part 11?
Should an audit trail record every key stroke?
Information Technology (IT) Service Providers and Services: REs that contract IT services should ensure the provider’s authenticity, integrity, and confidentiality when they are handling trial records and data.
What should REs include in agreements with IT service providers?
What should REs have available to demonstrate that the IT services are performed in accordance with FDA’s regulatory requirements?
Would FDA inspect or investigate IT service providers in a clinical investigation?
Digital Health Technologies (DHT): Defined as a system that uses computing platforms, connectivity, software, and/or sensors for health care and related uses.
When using DHTs to record data from participants in clinical investigations, how do sponsors identify the data originator?
How should data attribution be ensured when DHTs are used to record and transmit data in clinical investigations?
For inspection purposes, what is the location of the source data recorded by a DHT?
Electronic Signature: These are considered any series of symbols that are the legally binding equivalent of an individual’s handwritten signature.
Does FDA consider signatures drawn with a finger or an electronic stylus on a mobile platform or other electronic system to be electronic signatures?
What requirements must an electronic signature based on biometrics meet to be considered acceptable?
Are users of electronic signatures required to submit letters of non-repudiation to FDA to certify that an electronic signature is the legally binding equivalent of a traditional handwritten signature?
The full list of questions and answers can be found in the guidance on the FDA website, supplemental information can be found on the Federal Register, and since it is a final guidance, anyone can submit comments at any time on the docket. While this guidance gives a comprehensive overview of common questions and answers regarding ERs and ESs, if you or your company needs more extensive training on the subject, Clinical Pathways can help. Clinical Pathways offers a wide array of clinical trial consulting and training services that includes appropriate use of electronic systems, records, and signatures in clinical investigations as well as what to expect in an FDA audit when using them. For full list of our services and to subscribe to our blog and newsletter please visit our website: https://www.clinicalpathwaysresearch.com/.
-The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.