FDA revises guidance on electronic systems and signatures in clinical trials

The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the new guidance continues to use the questions and answers format of the previous version, the topics addressed have been updated to account for technological advances.
 
The document updates a previous draft guidance issued in 2017, and builds on the recommendations in FDA’s 2003 guidance on electronic records and signatures under CFR Part 11. FDA said the draft guidance, when finalized, will also supersede its 2007 guidance on computerized systems in clinical investigations. FDA said it recognizes that technology has advanced over the last two decades, necessitating the updated guidance. (RELATED: FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations, Regulatory Focus 20 June 2017)
 
“In addition, electronic systems and technologies are used and managed in novel ways, services are shared or contracted between organizations, and the electronic data flow between systems is more efficient and more prevalent,” FDA said. “The capabilities of electronic systems have improved, and features such as automated date and time stamps, audit trails, and the ability to generate complete and accurate copies and to archive records are standard components of many electronic systems.”
 
“Understanding the evolving uses of electronic records, electronic systems, and electronic signatures in clinical investigations is important for FDA in its assessment of the authenticity, integrity, and reliability of data submitted in support of marketing applications or submissions,” the agency added.
 
FDA said the new guidance updates recommendations for applying and implementing data integrity and data security controls, including the use of audit trails and the protection of records in the current environment of electronic systems used in clinical investigations. It also provides additional recommendations on the risk-based approach sponsors can take to validate electronic systems.
 
The updated guidance divides the Q&A topics by topics such as electronic records, electronic systems and electronic signatures. The guidance notably adds two new broad concepts including information technology (IT) and digital health technology (DHT).
 
In the previous draft guidance, the agency discussed mobile technology, outsourced electronic services, and telecommunication systems, which have been absorbed into other parts of the new guidance.
 
FDA said it is the responsibility of the sponsors and other regulated entities to ensure that the electronic records they submit through the IT vendors they use conform to the agency’s regulatory requirements. They need to consider, among other factors, the IT provider’s policies that may affect their clinical oversight abilities, processes and procedures that allow the user to validate the data and their ability to generate accurate and complete copies of records.
 
The guidance clarifies that DHT systems are defined by FDA as those that use computing platforms, connectivity, software and sensors for health care and related uses. They may be software- or hardware-based and may often run on general-purpose computing platforms such as mobile phones, tablets and smart watches.
 
FDA also points sponsors and other stakeholders to its 2021 draft guidance entitled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, which provides recommendations on DHT used for remote data acquisition from participants in clinical investigations evaluating medical products. When finalized, the agency said stakeholders can use that document to better understand DHTs that conform to its regulatory requirements.