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Use of Electronic Health Record Data in Clinical …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry
    EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. EHR systems can be used to integrate...

Electronic health records to facilitate clinical research

    https://pubmed.ncbi.nlm.nih.gov/27557678/
    Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns …

Using electronic health record data for clinical research: …

    https://pubmed.ncbi.nlm.nih.gov/35157608/
    Electronic health record (EHR) data not only offer many exciting research opportunities but also come with their own inherent limitations. Researchers may not …

Use of Electronic Records and Electronic Signatures in …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-records-and-electronic-signatures-clinical-investigations-under-21-cfr-part-11
    This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other …

Chapter 4 Obtaining Data From Electronic …

    https://www.ncbi.nlm.nih.gov/books/NBK551878/
    An EHR is an electronic system used and maintained by healthcare systems to collect and store patients’ medical …

The Importance and Use of Electronic Health Records in …

    https://www.sciencedirect.com/science/article/pii/B978012849905400040X
    The electronic medical record (EMR) and electronic health record (EHR) are platforms utilized within both clinical care and clinical research settings to collect …

Using electronic health records for clinical …

    https://www.cmaj.ca/content/191/5/E128
    Electronic health records allow the add-on of interventions or software directly in the workflow of the clinical team, enabling clinicians to become the research …

Introduction - Rethinking Clinical Trials

    https://rethinkingclinicaltrials.org/chapters/design/using-electronic-health-record-data-pragmatic-clinical-trials-top/using-electronic-health-record-data-in-pragmatic-clinical-trials-introduction/
    Using electronic health record (EHR) data for research is fundamentally different than collecting the research data prospectively, as is traditional for controlled clinical trials. …

Using electronic health records for clinical research: the …

    https://pubmed.ncbi.nlm.nih.gov/25463966/
    This will be achieved through multiple but unified initiatives across different major disease areas (e.g. cardiovascular, cancer) and clinical research use cases (protocol feasibility, …

Use of Electronic Health Record Data in Clinical …

    https://www.fda.gov/files/drugs/published/Use-of-Electronic-Health-Record-Data-in-Clinical-Investigations-Guidance-for-Industry.pdf
    Electronic Health Record (EHR) — An individual patient record contained within the EHR system. A typical individual EHR may include a patient’s medical history, …



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