EMERGO SUMMARY OF KEY POINTS

• New US FDA guidance updates recommendations for using electronic records and signatures in medical device clinical investigations.
• Clinical trial sponsors are required to ensure reliability, trustworthiness and auditability of electronic records and signatures.
• Risk-based validation of electronic records and signatures is required especially for critical clinical study data.

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations.

The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures. The FDA requires that electronic records and signatures are reliable and trustworthy, and that validations of electronic systems are carried out using risk-based approaches.

Types of electronic records covered by the guidance

Specific types of electronic records and signatures falling under the scope of the new FDA guidance include:

• Records kept in electronic format in lieu of paper format that regulators would require in order to reconstruct a medical device clinical study
• Electronic records used to perform regulated clinical study activities
• Records submitted to the FDA in electronic format according to predicate rules
• Electronic signatures intended as equivalent to hand-written signatures

Electronic systems used to maintain the types of records and signatures listed above are also covered by the guidance; these include commercial off-the-shelf and customized systems used by clinical study sponsors, outsourced electronic services and mobile technologies.

How to apply risk-based validation to electronic systems

The FDA includes a lengthy Q&A section in the guidance to address various issues related to 21 CFR Part 11 compliance. First among these topics is how to meet risk-based validation requirements for electronic records and signatures.

Risk-based validation of electronic systems is necessary, states the guidance, given how variable different systems’ reliability and complexity are. Clinical investigators, sponsors and IRBs should consider the purpose and importance of particular electronic records, as well as attributes and intended use of the electronic system used to produce a particular record.

“In general, sponsors and other regulated entities should have electronic systems validated if those systems process critical records…that are submitted to FDA,” states the guidance. “The extent of validation should be tailored to the nature of the system and its intended use.”

However, the FDA does not provide recommendations on specific risk assessment techniques or methods in the draft guidance. Instead, the agency recommends other resources including the International Council for Harmonization’s Q9 Quality Risk Management and ISO 31010:2009 Risk Management—Risk Assessment Techniques.

Medical device clinical trial sponsors and related stakeholders should consult the full guidance—especially its Q&A section—to determine how best to implement the FDA’s recommendations.

Additional US FDA and clinical resources:

• Medical device clinical study audit support
• US FDA medical device and IVD regulatory strategy support
• US FDA Pre-Sub consulting for medical device companies
• Whitepaper: Clinical data to support FDA 510(k) submissions