05/02/2023

The US Food and Drug Administration (FDA) released a draft guidance “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers” in March 2023. When finalized, it will replace the 2007 guidance “FDA Computerized Systems Used in Clinical Investigations.” The FDA regulates electronic systems, electronic records, and electronic signatures used by sponsors and CROs to create records required for clinical trials per 21 CFR Part 11. Part 11 is a companion regulation to other FDA regulations and laws called "predicate rules,” where specific requirements for recordkeeping, record content, signatures, and record retention are addressed (e.g., 21 CFR Parts 312 and 812). Other guidance documents related to Part 11 are “Electronic Records and Signatures Scope and Application” from 2003, “Electronic Source Data in Clinical Investigations” from 2013, and “Electronic Source Data in Clinical Investigations” from 2020. The current regulatory landscape of electronic systems is changing rapidly and other guidance documents are likely.

Some notable recommendations from the draft questions and answers guidance are:

Sponsors should review the vendor’s SOPs, the system and software development life cycle model, validation documentation, change control procedures, and change control tracking logs.
In addition, sponsors should perform user acceptance testing (UAT) and document the criteria for and results of testing to ensure that the electronic system fulfills its intended purpose. Alternatively, sponsors should review the vendor’s UAT and document that the UAT was reviewed and was found to be adequate, and this should be documented.
In an inspection, the FDA could focus on staff training records on the use of the eSystem, procedures and controls that are in place for system access, data creation, data modification, and data maintenance, and the site’s use of the eSystem to generate, collect, transmit, and archive data.

Comment on the draft guidance now through May 15, 2023 HERE.

Does your team need training on clinical trials electronic systems to be inspection ready? Clinical Pathways offers eLearning and live training. For more information or to purchase eLearning, visit our online store here: https://www.clinicalpathwaysresearch.com/store/esystems/

Contact us at info@clinicalpathwaysresearch.com for information about live or enterprise training.

- The Clinical Pathways Team

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