7/24/2018

The Food and Drug Administration (FDA) published a guidance document on July 18, 2018, entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry,” which finalizes the draft guidance released in May 2016. The purpose of the guidance is to support industry in use of electronic data capture systems (EDC) and electronic health records (EHR) while protecting the confidentiality, integrity, and security of data. The guidance aligns with the 21st Century Cures Act, which prompted the FDA to publish guidance for use of “real-world evidence” in regulatory activities.

Background

Interoperable systems can transmit electronic data directly between the two electronic systems. For example:
- An EDC that can transmit data to populate fields within an electronic case report form (eCRF)
Fully integrated systems allow research data to be entered into the EHR without additional systems. For example:
- EHR data that can transmit data to populate eCRF
Such systems would reduce the risk of transcription errors

Best Practices to Support Transmission of Electronic Data Directly Between Two Electronic Systems

Currently, EHRs are commonly used as supporting source data for an eCRF. Risks of missing data and transcription errors should be considered.
Additional considerations apply to EHR utilized as data for clinical investigations.
- The sponsor’s quality management plan should include:
  - Validation of interoperability of systems and electronic transmissions of data
  - A routine audit of electronic data for accuracy, consistency, and completeness
- Monitors must have access to electronic data, and a description of the data accessed must be in the informed consent form
- Adequate security measures to ensure data integrity and protection of subject confidentiality should be employed
- Descriptions of each EHR system at the sites should be recorded in the sponsor’s data management plan
- EHR technology certified under the Office of the National Coordinator for Health Information Technology (ONC) Health Information Technology (IT) Certification Program would be in compliance with 45 CFR part 17.
- Sponsors using EHR technology not certified under ONC IT Certification would need to:
  - Employ adequate security measures
  - Limit access to authorized users
  - Establish the identity of users
  - Ensure there are audit trails
  - Retain records as required by the applicable regulations

Electronic Source (eSource)

EHR systems are not covered under 21 CRF part 11, but EDC must comply with part 11
- This includes EHR systems that use data from EDC and EDC that rely on data from EHRs
A data originator should be identified for recordkeeping
- The EHR may be identified as the data originator
Just as with paper case report forms, only authorized site staff must have access to modify content in eCRFs, and changes must be tracked via an audit trail
Sponsors should consider if the use of EDC or EHR has the potential to inadvertently break the blind, for applicable trials
Sponsors and investigators should understand the electronic systems and add language to the informed consent form describing any additional individuals who may have access to electronic data

Records

Retention of electronic records is required by the applicable regulations, the same as for paper, including the EHR when considered eSource
Any data pertinent to the FDA’s inspection must be made available to view or copy as original EHR or as a certified copy and should include an audit trail

The new Guidance is a next step in the modernization of clinical trials to include electronic data capture systems and health records. Understanding the FDA’s position on EDC and EHR integration may lead to the advancement of more interoperable systems, thus reducing the risk of data transcription errors and improving documentation and audit trail in future clinical trials.

- The Clinical Pathways Team

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