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A Novel Definition of Urinary Tract Infection across a National Primary Care Network [Geriatrics]

Annals of Family Medicine

Objective To develop and validate a novel electronic medical records (EMR)-based UTI case definition that can be applied to elucidate and understand UTI treatment and practice patterns in primary care. Context Misdiagnosis and over-diagnosis of urinary tract infection (UTI) are a leading cause of inappropriate antimicrobial use.

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The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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Episode 293 – Antiracism in Medicine Series – Episode 22 – Live from SGIM 2023: Best of Antiracism Research at the Society of General Internal Medicine’s 2023 Annual Meeting

The Clinical Problem Solvers

Describe difficulties and examples of how to measure unconscious race bias in medical practice. Identify strategies to mitigate bias and stigma in the electronic health record as a trainee and medical practitioner. He has also served as a Council member and Secretary of SGIM.

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Card studies using EHR alerts linked to REDCap questionnaires: a practical session on how to build the tools [Research methodology and instrument development]

Annals of Family Medicine

Background Researchers use card studies to obtain observational data about primary care provider (PCP) knowledge, attitudes, and behaviors on a variety of topics. Card studies have been influential in changing clinical practice, such as the reduction of antibiotics in patients with upper respiratory infections.

PCP 130
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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. Provide both completed and planned actions and related timelines.

Provider 111
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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

Medical 111
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Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

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