Use of Electronic Health Record Data in Clinical Investigation Guidance for Industry

Use of Electronic Health Record Data in Clinical Investigations Guidance for In-

dustry

AMC CPT | Resident Sungpil Han

2016-06-22 | [email protected]

Keywords

EHR ONC (The Office of the National Coordinator) Interoperability, Interoperable technology Digital Standards Digital Signature ALCOA

Ref : HealthIT.gov

HealthIT.gov

HealthIT.gov

I. INTRODUCTION

Purpose of Guidance

Intended to assist sponsors, clinical investi-gators, contract research organizations, IRBs, and other interested parties on the use of EHR data in FDA-regulated clinical inves-tigations

What is EHR?

Electronic platforms with individual elec-tronic health records for patients

Maintained by health care organizations and institutions.

Include• patient’s medical history, diagnoses, treatment

plans, immunization dates, allergies, radiology images,

• pharmacy records, and laboratory and test re-sults.

This guidance provides recommenda-tions

Deciding whether and how to use EHRs as a source of data in clinical investigations

Using EHRs that are interoperable with EDC(Electronic data capture) system.

Ensuring the quality and the integrity of EHR data that are collected and used as elec-tronic source data in clinical investigations

Ensuring that the use of EHR data meets FDA’s inspection, recordkeeping, and record retention requirements

Goals of this guidance are as follows

Modernizing and streamlining clinical in-vestigations• Facilitate the use of EHR data in clinical investi-

gations• Promote the interoperability of EHRs and elec-

tronic systems supporting the clinical investiga-tion

Disclaimer

This does not establish legally enforceable responsibilities.

Guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations.

II. SCOPE

Scope

Use of EHR data in prospective clinical inves-tigations • drugs,• biological products, • medical devices,• combination products.

III. BACKGROUND

Electronic source data, eCRF and EHR

FDA issued guidance on electronic source data in clinical investigations (eSource guidance).

Addressing attributes of source data• Electronic CRF (eCRF)

FDA’s inspection, recordkeeping, and record retention re-quirements

• Derived from a variety of sources, including EHRsEHRs• not under the control of FDA-regulated entities (e.g.,

sponsors, clinical investigators)• belong to health care organizations and institutions.

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Quality of EHRs

As provided in the eSource guidance, FDA does not intend to assess compliance of EHRs• 21 CFR part 11.14. ( 전자기록 및 전자서명에 관한

법령 )However, FDA’s acceptance of data from

clinical investigations for decision-mak-ing purposes • depends on FDA’s ability to verify the quality

and the integrity of data during FDA on-site inspections and audits

Sponsor’s responsibility

Sponsors are responsible for assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product.

Potential Advantages of EHRs

Widespread use of EHRsOpportunities to improve patient safety,

data accuracy, and clinical trial effi-ciency

Enable clinical investigators and study per-sonnel to more easily combine, aggregate, and analyze data from many different sources• clinical notes; physician orders; and radiology,

laboratory and pharmacy records

Real-time and longitudinal health care data

Provide clinical investigators and study per-sonnel access to real-time and longitudi-nal health care data for review and can fa-cilitate post-trial follow-up on patients to as-sess long-term safety and efficacy of medical products.

Opportunities for long-term follow-up of large numbers of patients in studies where primary endpoints are rare, such as in pro-phylaxis studies.

IV. INTEROPERABILITY

Interoperability

Ability of two or more systems or com-ponents to exchange information

Interoperable EHR-EDC system

Interoperability and automated electronic exchange of information between the EHR and EDC• Simplify data collection for a clinical investiga-

tion by enabling clinical investigators and study personnel to capture source data at the time of a subject’s point-of-care visit.

• Reduce errors in data transcription and provide data that is more accurate and complete allowing for improvement in the quality of clinical investi-gations and the interpretation of data.


Depends on supportive technologies and standards

Interoperable technology• Automated electronic transmission of relevant

EHR data to the EDC system• Data elements originating in an EHR automati-

cally populate the eCRFs demographics, vital signs, past medical history, past surgi-

cal history, social history, medications, adverse reactions

Such access must be described in the in-formed consent


Ability to integrate with other health care clinical information systems (e.g., radiology information systems, laboratory information systems).

Data traceability• Originator of the data elements should be iden-

tified along with an electronic date and time stamp at the time

• 21 CFR part 11 Electronic Signatures

Interoperable vs noninteroperable tech-nology

Noninteroperable technology• No capability for direct exchange of EHR data in clini-

cal investigations• Manual transcription of data elements

From the EHR to the eCRF or to the paper CRF

Practical challenges • Complex and diverse clinical data standards• diverse ownership of electronic systems

Data standards• standardization requirements as part of the • ONC Health Information Technology (Health IT)

Certification Program.

https://www.healthit.gov/standards-advisory/draft-2016

V. BEST PRACTICES FOR THE USE OF EHR DATA IN CLINICAL INVESTIGA-

TIONS

BEST PRACTICES

Fundamental elements of data = AL-COA• Attributable : is it obvious who wrote it?• Legible : can it be read?• Contemporaneous : Is the information cur-

rent and in the correct time frame?• Original : is it a copy; has it been altered?• Accurate : are conflicting data recorded

elsewhere?

Use of EHRs

Confidentiality, integrity, and reliability of data. • Access to electronic systems is limited to

authorized users• Authors of records are identifiable• Audit trails are available to track

changes to data

VI. OTHER GENERAL CONSIDERA-TIONS FOR BEST PRACTICES

A. Use of EHRs in Clinical Investigations

Protocol or data management plan• information about the intended use of

the EHR during a clinical investigation• description or diagram of the electronic

data flow • description of how the relevant EHR

data are extracted and subsequently imported into the sponsor’s EDC.


Reviews• check the extracted data for consistency

and completeness • make corrections when errors • ensure that software updates to the spon-

sor’s electronic system or the EHR do not affect the reliability and the integrity of EHR data entering the sponsor’s elec-tronic system.


Archive and backupDiscuss with the relevant FDA review divi-

sion any unique issues or challenges encoun-tered that are related to the data collection from the EHRs.

B. Data Modifications

The sponsor’s electronic system should capture any updated information as well as any accompanying audit trail information.

C. Audit Trails

Adequate methods to monitor, track, and document all changes

FDA Inspection• Identification of the data originator • Date and time data

Audit trail documentation of the EHR • should be retained for a time period that is at

least as long as the time period required for the subject’s electronic records and should be available for FDA to review and copy

D. Informed Consent

Confidentiality of records identify-ing the subject will be maintained

All entities with access to the pa-tient’s electronic health record

Foreseeable risks with the use of EHRs• increased risk of data breaches- must be

described to the subject in the informed consent

E. Privacy and Security of Data

comply with any privacy and secu-rity requirements applicable to their institution or organization.

VII. INSPECTION, RECORDKEEPING, AND RECORD RETENTION REQUIRE-

MENTS

INSPECTION, RECORDKEEPING, AND RECORD RETENTION REQUIREMENTS

FDA • Have access to records • Inspect and copy all records pertaining to a clinical inves-

tigation Paper or electronic records to support data in the eCRF

• case histories, other data pertaining to the clinical investiga-tion

Clinical investigators must retain all paper and elec-tronic source documents (e.g., originals, certified copies)

2 years following the date a marketing application is approved

Thank You For Listening.

Reference1. Use of Electronic Health Record Data in Clinical

Investigations Guidance for Industry, FDA, 2016.2. Guidance for Industry Electronic Source Data in

Clinical Investigations, FDA, 2013.3. 2016 Interoperability Standards Advisory, ONC,

2016.

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Use of Electronic Health Record Data in Clinical Investigation Guidance for Industry