As the landscape of clinical research continues to evolve, integrating Digital Health Technologies (DHTs) presents unique challenges and opportunities for sponsors and investigators. This post highlights key considerations for ensuring data integrity and the proper use of electronic signatures within clinical investigations involving DHTs, as outlined by the Food and Drug Administration Guidance, “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.”
Identifying Data Originators
In clinical investigations utilizing DHTs, sponsors must clearly identify data originators. Clarity can include:
- Participants: When participants manually enter data (e.g., through electronic patient-reported outcome applications), they are identified as the data originators.
- Clinical Trial Personnel: If another individual enters data on behalf of a participant, that individual must be documented as the data originator, along with the reason for the participant’s absence.
- Automated Systems: The DHT itself is considered the data originator for DHTs that transmit data without human intervention, such as activity trackers. Metadata, including the date and time of recording, should be part of the data repository for audit purposes.
Maintaining an authorized list of data originators is essential, and security measures must be implemented to protect access controls, ensuring that only authorized individuals can modify or transmit data.
Ensuring Data Attribution
To maintain data integrity, sponsors must implement measures to ensure that data obtained from DHTs are correctly attributed to the respective data originators. Key strategies include:
- Access Controls: Employing security measures such as personal identification numbers, biometrics, and multi-factor authentication for applications requiring user entry.
- User Education: Informing participants about the appropriate use of DHTs and emphasizing that they should not share their access credentials with others.
- Documentation: Recording discussions about DHT usage in clinical investigation records helps maintain clarity and accountability.
Data Transfer Protocols
Data transmission from DHTs to durable electronic data repositories must follow validated processes outlined in the sponsor’s pre-specified plan. Key considerations include:
- Timeliness: Data should be transmitted contemporaneously or as soon as possible after being recorded.
- Audit Trails: Each transfer should be documented with the date and time, contributing to the overall audit trail for verification purposes.
- Source Data Location: For inspection purposes, electronic source data should be located within the durable electronic data repository rather than on individual DHTs.
Understanding Electronic Signatures
In clinical investigations, electronic signatures are legally binding equivalents of handwritten signatures. Important points regarding electronic signatures include:
- Linking Signatures to Records: Electronic signatures must be linked to their respective records to prevent tampering.
- Signature Requirements: Electronic signatures must consist of the signer’s printed name, along with the date and time of signing.
- Verification Methods: Various methods can be employed to verify an individual’s identity when signing records, including government-issued IDs and multi-factor authentication.
- Biometric Signatures: Electronic signatures based on biometric data must ensure exclusivity to the authorized user.
Compliance and Certification
While the FDA does not certify electronic systems for obtaining electronic signatures, organizations must submit a letter of non-repudiation to certify that their electronic signatures are legally binding. This step is essential for regulatory compliance and maintaining the integrity of electronic records.
Conclusion
As DHTs become more integrated into clinical investigations, sponsors and investigators must prioritize data integrity, proper identification of data originators, secure data transfer processes, and compliant electronic signatures. By adopting robust strategies and maintaining transparent protocols, stakeholders can leverage the benefits of DHTs while ensuring compliance with regulatory requirements.
View the Federal Register Notice for more information.
