FDA Electronic Health Record Data in Clinical Research
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The document presents FDA guidance on the use of electronic health record (EHR) data in clinical investigations, emphasizing interoperability, best practices, and regulatory compliance. Key topics include the importance of using certified EHR systems, ensuring data integrity and security, and the need for collaboration between healthcare organizations and clinical researchers. The guidance aims to improve data accuracy and enhance clinical trial efficiency while addressing inspection and recordkeeping requirements.
FDA Electronic Health Record Data in Clinical Research
- 1. FDA Electronic Health Record Data in Clinical Research North American eClinical Forum Autumn Meeting Jules T. Mitchel, MBA, PhD 2 October 2018
- 2. Use of Electronic Health Record Data in Clinical Investigations • Guidance for Industry, Issued 18 July 2018 • U.S. Department of Health and Human Services • Food and Drug Administration • Center for Drug Evaluation and Research (CDER) • Center for Biologics Evaluation and Research (CBER) • Center for Devices and Radiological Health (CDRH)
- 3. Table of Contents 1. Interoperability and Integration of Systems • Data Standards • Structured and Unstructured data • Validation • Data from Multiple EHRs 2. Best Practices for Using EHRs in Clinical Investigations • Use of Health Information Technology Certified by the Office of the National Coordinator for Health Information Technology ONC • Use of Health Information Technology not Certified by ONC • eSource Principles for EHRs • Blinded Study Designs • Informed Consent 3. Inspection, Recordkeeping, and Record Retention Requirements
- 4. What Are Electronic Health Record (EHR) Systems? 1. Electronic health record (EHR) systems are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. 2. A typical individual EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and laboratory and test results.
- 5. Guidance Recommendations 1. Deciding whether and how to use EHRs as a source of data in clinical investigations 2. Using EHR systems that are interoperable with EDC systems in clinical investigations 3. Ensuring the quality and integrity of EHR data collected and used as electronic source data in clinical investigations 4. Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements
- 6. Scope of the Guidance 1. Use of EHRs in prospective clinical investigations of human drugs and biological products, medical devices, and combination products, including clinical investigations conducted in clinical practice settings 2. Use of EHRs in foreign clinical studies not conducted under an investigational new drug application (IND) or an investigational device exemption (IDE) that are submitted to FDA in support of an application for the marketing approval of a medical product
- 7. Not Included in the Scope of the Guidance 1. Health IT such as mobile and telehealth technology, medical devices and remote monitoring devices, assistive technologies, and sensors. 2. The use of EHR data in postmarketing observational pharmacoepidemiologic studies designed to assess adverse events and risks associated with drug exposure or designed to test prespecified hypotheses for such studies. 3. The use of EHR data to evaluate feasibility of the trial design or as a recruitment tool for clinical investigations. 4. Data collected for registries and natural history studies.
- 8. Advantages of Using EHR Data 1. With the widespread use of EHRs, there are opportunities to improve data accuracy and promote clinical trial efficiency when EHRs are used in clinical investigations. 2. EHRs may enable clinical investigators and study personnel to have access to many types of data (e.g., clinical notes, physician orders, radiology, laboratory, and pharmacy records) that can be combined, aggregated, and analyzed.
- 9. Advantages of Using EHR Data 1. EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products. 2. In addition, there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies.
- 10. FDA is Encouraging Pharma to be Interoperable 1. FDA encourages sponsors and clinical investigators to work with entities that control EHR systems, such as health care organizations, to use EHR and EDC systems that are interoperable or fully integrated. 2. However, diverse ownership of electronic systems and data may necessitate appropriate collaboration between the health care and clinical research communities. 3. Therefore FDA encourages sponsors and health care organizations to work with EHR and EDC system vendors to further advance the interoperability and integration of these systems.
- 11. Data Standards 1. Many of these challenges are being addressed by the adoption of open data standards and through EHR data standardization requirements as part of The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program and ONC’s Interoperability Standards Advisory. 2. The data exchange between EHR and EDC systems should leverage the use of existing open data standards, when possible, while ensuring that the integrity and security of data are not compromised
- 12. Structured and Unstructured Data 1. FDA encourages exchange of structured data (e.g., demographics, vital signs, laboratory data) between EHR and EDC systems so that data may be entered once at the point-of-care and used many times without manual re-entry or manual source data verification. 2. Sponsors should ensure that the structured data elements obtained from the EHR correspond with the protocol-defined data collection plan (e.g., time and method of measurement). In addition, for extraction of unstructured data, sponsors should consider the reliability and quality of unstructured EHR data and the appropriateness of using it as critical source data, such as study endpoints
- 13. Validation 1. Sponsors should ensure that the interoperability of EHR and EDC systems (e.g., involving the automated electronic transmission of relevant EHR data to the EDC system) functions in the manner intended in a consistent and repeatable fashion and that the data are transmitted accurately, consistently, and completely. 2. The sponsor’s quality management plan (e.g., standard operating procedures, software development life cycle model, change control procedures) should address the interoperability of the EHR and EDC system and the automated electronic transmission of EHR data elements to the EDC system.
- 14. Validation 1. Sponsors should ensure that software updates to the sponsor’s EDC systems do not affect the integrity and security of EHR data transmitted to the sponsor’s EDC systems. 2. In addition, as part of the quality management plan, FDA encourages sponsors to periodically check a subset of the extracted data for accuracy, consistency, and completeness with the EHR source data and make appropriate changes to the interoperable system when problems with the automated data transfer are identified.
- 15. Data From Multiple EHR Systems 1. The EHR system at the clinical investigation site may be interoperable with multiple EHR systems from many different health care organizations or institutions that are not affiliated with the clinical investigation site. 2. If data from multiple EHR systems from different health care organizations and institutions are integrated with EHR data at the clinical investigation site, data from another institution’s EHR system may be used and transmitted to the sponsor’s EDC system provided that data sharing agreements are in place.
- 16. Best Practices in Clinical Trials 1. Sponsors and clinical investigators should ensure that policies and processes for the use of EHRs at the clinical investigation site are in place and that there are appropriate security measures employed to protect the confidentiality and integrity of the study data. 2. Sponsors should also ensure that study monitors have suitable access to all relevant subject information pertaining to a clinical investigation, as appropriate. Such access must be described in the informed consent. 3. At any time during the course of a clinical investigation, sponsors should discuss with the relevant FDA review division any unique issues or challenges encountered relating to the data collection from the EHRs.
- 17. Health Information Technology Certified by ONC 1. Under the ONC Health IT Certification Program, certified EHR technology should be in compliance with applicable provisions under 45 CFR part 170. 2. EHR technology with certified capabilities generally has clear advantages, because many of the certification requirements are aimed toward ensuring interoperable data sharing and enabling processes to keep electronic data confidential and secure. In particular, all EHR technology certified under the ONC Health IT Certification Program is required to meet certain privacy and security protection requirements for an individual’s health. 3. FDA encourages the use of such certified EHR systems together with appropriate policies and procedures for their use
- 18. Health Information Technology Not Certified by ONC 1. FDA recognizes the importance of data from foreign studies to support safety and efficacy claims for medical products and may accept data from clinical studies conducted outside the United States. 2. EHR systems not certified by ONC, including EHR systems at foreign clinical sites, can provide adequate data to inform FDA’s regulatory decisions provided that adequate controls are in place to ensure the confidentiality, integrity, and security of data.
- 19. Health Information Technology Not Certified by ONC For EHR systems not certified by ONC, sponsors should consider whether such systems have the following privacy and security controls in place to ensure that the confidentiality, integrity, and security of data are preserved: 1. Policies and processes for the use of EHR systems at the clinical investigation site are in place, and there are appropriate security measures employed to protect the study data. 2. Access to electronic systems is limited to authorized users. 3. Authors of records are identifiable. 4. Audit trails are available to track changes to data. 5. Records are available and retained for FDA inspection for as long as the records are required by applicable regulations
- 20. Health Information Technology Not Certified by ONC 1. Sponsors should consider the previous factors when determining the suitability of EHR systems not certified by ONC for use in clinical investigations. 2. If the clinical investigation site is using a system that does not contain the adequate controls previously described in the items above, sponsors should consider the risks of employing such systems (e.g., the potential harm to research subjects, patient privacy rights, and data integrity of the clinical investigation and its regulatory implications).
- 21. Health Information Technology Not Certified by ONC The following information may be helpful to sponsors to determine the suitability of EHR systems not certified by ONC: 1. Any EHR system certification information from other authorizing bodies outside the United States, including information about aspects of the EHR system that the authorizing body evaluated when certifying the EHR system 2. Feature and product-specification information from the EHR system vendor Sponsors should consult with the relevant FDA review divisions if any issues or challenges with the EHR system are identified.
- 22. Data Management Plan Documentation 1. Sponsors should include in their data management plan a list of EHR systems used by each clinical investigation site in the clinical investigation. Sponsors should document the manufacturer, model number, and version number of the EHR system and whether the EHR system is certified by ONC. 2. If an EHR system is decertified during the course of the clinical investigation because the system no longer conforms to ONC’s certification criteria, sponsors should determine the nature or reasons for the nonconformity and determine whether it would affect the quality and integrity of data used in the clinical investigation.
- 23. eSource Principles: Data Originator 1. For the purposes of recordkeeping, audit trails, and inspection, each electronic data element should be associated with a data originator. 2. The EHR is identified as the data originator for EHR data elements gathered during the course of a clinical investigation. 3. Identifying the EHR as the data originator may be sufficient because sponsors are not expected to know details about all users who contribute information to the patient’s EHR.
- 24. eSource Principles: Data Modification 1. After data are transmitted to the eCRF, the clinical investigator or delegated study personnel should be the only individuals authorized to make modifications or corrections to the data. 2. Modified and corrected data elements should have data element identifiers that reflect the date, time, data originator, and the reason for the change. 3. Modified and corrected data should not obscure previous entries.
- 25. eSource Principles: Data Modification 1. Clinical investigators should review and electronically sign the completed eCRF for each study participant before data are archived or submitted to FDA. 2. If modifications are made to the eCRF after the clinical investigator has already signed the eCRF, the changes should be reviewed and approved by the clinical investigator. 3. Use of electronic signatures for records that are subject to 21 CFR part 11 must comply with relevant requirements in that regulation.
- 26. eSource Principles: Informed Consent 1. When informed consent is required, the consent must include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and should identify entities, such as health care providers, clinical investigators, sponsors, contract research organizations, study monitors, and regulatory agencies who may gain access to the patient’s electronic health record relating to the clinical investigation. 2. In addition, the consent process must also note the possibility that FDA may inspect records and should not state or imply that FDA needs permission from the subject for access to the records.
- 27. Inspection, Recordkeeping, and Record Retention 1. FDA must have access to records and may inspect and copy all records pertaining to a clinical investigation. 2. All relevant information in the EHR pertaining to the clinical investigation must be made available to FDA for review upon request. 3. This information should be made available and viewable to FDA as original records in the EHR or as certified copies. 4. During an inspection, FDA may also request other paper or electronic records to support data in the eCRF (e.g., case histories, other data pertaining to the clinical investigation). In addition, FDA may request to review the EHR audit trail information during inspection.
- 28. Thank You Jules T. Mitchel, MBA, Ph.D., President Target Health Inc. 261 Madison Avenue, 24th Floor, New York, NY 10016 jmitchel@targethealth.com www.targethealth.com TARGET HEALTH INC., founded in 1993, is a private, New York City-based, full-service eCRO, engaged in all aspects of Drug and Device Development, including Regulatory Affairs Strategic Planning, Clinical Research, Data Management, Biostatistics, Medical Writing and the paperless clinical trial.