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{"id":285,"date":"2018-09-26T09:53:06","date_gmt":"2018-09-26T09:53:06","guid":{"rendered":"https:\/\/www.pharmity.com\/?p=285"},"modified":"2019-11-12T15:34:05","modified_gmt":"2019-11-12T15:34:05","slug":"how-to-assess-an-electronic-health-records-ehr-system-for-clinical-research","status":"publish","type":"post","link":"https:\/\/www.pharmity.com\/staging\/?p=285","title":{"rendered":"How to Assess an Electronic Health Records (EHR) System for Clinical Research"},"content":{"rendered":"
Whether<\/span> paper or eSource,<\/strong> investigators and sponsors need to ensure that there are adequate controls in place to preserve the confidentiality, integrity, and security of data.\"How<\/span><\/strong><\/h5>\n
Electronic Health Records (EHR) systems need to be assessed by the Sponsor and\/or CRO for compliance with regulatory requirements before investigator sites activation, but how can this type of systems be assessed? What are the main challenges of EHR systems hosting source data for clinical studies?
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\nThis article reviews the latest Guidance for Industry published in Jul 2018 by the FDA \u201cUse of Electronic Health Record Data in Clinical Investigations\u201d1<\/sup> and compares it with the Reflection paper released by the EMA on the same topic in 2010 \u201cExpectations for electronic source data and data transcribed to electronic data collection tools in clinical trials\u201d2<\/sup>.<\/span><\/strong><\/h5>\n

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\nThe May 2007 FDA Guidance for Industry \u201cComputerized Systems Used in Clinical Investigations\u201d was instrumental in helping to ensure that records generated by a EHR system (understood as a computerized system used in clinical investigations to generate and maintain source data<\/strong><\/span> on each clinical trial subject) are GCP compliant<\/strong><\/span> and must meet the same fundamental elements of data quality<\/span><\/strong> (ALCOA+ Principles: Accurate, Legible, Contemporaneous, Original, Attributable, Complete, Consistent) that are expected of paper records3<\/sup>.
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\nAfter reviewing in detail, the long-awaited Guidance for Industry on the \u201cUse of Electronic Health Record Data in Clinical Investigations\u201d released in July 2018, I do not believe it helps to clarify the multiple doubts around the use of Electronic Health Records (EHRs) as a source of data in clinical investigations.<\/span><\/p>\n

The new Guidance states that the FDA encourages sponsors and clinical investigators to work with health care organizations to use the EHR and EDC systems that are interoperable or fully integrated and the Guidance content tends to revolve around interoperability1<\/sup>. Even though EHR-EDC systems integration it is recognized to be the future, it is not today\u2019s most common environment.
\n<\/span>What the new Guidance clarifies is that EHR systems are not under the control of FDA-regulated entities (e.g. sponsors, clinical investigators)1<\/sup>. The investigator sites had been dealing with the varying interpretations on how FDA\u2019s Part 11 applied to EHRs, but FDA does not intend to assess compliance of EHRs systems with 21 CFR Part 11.<\/span><\/p>\n

\u201c21 CFR Part 11 is not mandatory for a site\u2019s EHR system. It has been confused desirable characteristics of Part 11 as full Part 11 compliance\u201d<\/span><\/p><\/blockquote>\n

The main point about EHRs systems is that they are developed and maintained by the health institutions for general patient medical records. Consequently, they are part of the practice of medicine which FDA does not regulate. However, since these EHR systems hold data relevant to clinical studies, they should have the major elements found in 21 CFR Part 11 that are pertinent to the integrity of data and this is what the new FDA Guidance highlights: \u201cFDA\u2019s acceptance of data from clinical investigations for decision-making purposes depends on FDA ability to verify the quality and integrity of the data during FDA inspections\u201d1<\/sup>.<\/span><\/p>\n

The EMA \u201cReflection paper on expectations for electronic source data transcribed to electronic data collection tools in clinical trials\u201d published in 2010, in my opinion covers the topic following a more practical approach. The Reflection paper refers to the twelve requirements stated in the CDISC (Clinical Data Interchange Standards Consortium) standard for source data4<\/sup>, irrespective of the technology used to hold the data and provides recommendations on how to meet them2<\/sup> (see Table 1).<\/span><\/p>\n

\"How<\/a><\/p>\n

In addition, to the above requirements, the following aspects also need to be considered5<\/sup>:<\/span><\/p>\n