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Related Concept Videos

Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Ethical Standards I01:25

Ethical Standards I

The American Nurses Association (ANA) created and implemented the first nationally accepted Code of Ethics for Nurses with Interpretive Statements. The Code of Ethics is a living document regularly updated by the ANA and establishes an ethical standard that is non-negotiable for nurses in all roles and settings.
The Code of Ethics provisions outline the nurse's duty to the patient, the healthcare team, the profession, and society. The Code's fundamental principles include advocacy,...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

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Related Experiment Video

Updated: May 24, 2026

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
07:50

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

Implementation and FAIR Evaluation of Clinical Data Provision Framework.

Shozo Konishi1, Kazuo Okamura2, Aoi Yamaguchi2

  • 1Department of Medical Informatics, The University of Osaka Graduate School of Medicine.

Studies in Health Technology and Informatics
|May 23, 2026
PubMed
Summary
This summary is machine-generated.

A new framework enables secure secondary use of hospital clinical data while protecting patient privacy. This model enhances data sharing for research, achieving high FAIR data maturity except for interoperability.

Keywords:
FAIR principle evaluationdata cataloghospital-based frameworkprivacy protectionsecondary use of medical data

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The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
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The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

Related Experiment Videos

Last Updated: May 24, 2026

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
07:50

A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts

Published on: September 20, 2018

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time
06:05

The Participant-Reported Implementation Update and Score (PRIUS): A Novel Method for Capturing Implementation-Related Data Over Time

Published on: February 19, 2021

Area of Science:

  • Medical Informatics
  • Data Science
  • Health Data Governance

Background:

  • Growing demand for secondary use of clinical data from industry and academia.
  • Need to balance analytical utility with stringent patient privacy requirements.
  • Existing frameworks may not adequately address both data utility and privacy concerns.

Purpose of the Study:

  • To develop and implement a hospital-based data-provision framework for secure secondary data use.
  • To balance analytical utility with patient privacy using anonymized data and hash-based indices.
  • To establish a scalable model for FAIR (Findability, Accessibility, Interoperability, Reusability)-oriented data sharing in medical institutions.

Main Methods:

  • Developed a lightweight, hospital-based framework with three layers: hospital, PLR platform, and secondary users.
  • Implemented anonymized research IDs and hash-based data indices for temporal reconstruction without actual dates.
  • Separated the data catalog (research IDs, observation indices, hash-based indices) from the securely stored dataset.
  • Utilized the PLR platform for overall coordination and access governance.
  • Applied the framework to a perinatal cohort, generating four data categories.

Main Results:

  • The framework successfully enabled secure secondary data use for a perinatal cohort.
  • FAIR evaluation showed high maturity in Findability, Accessibility, and Reusability.
  • Interoperability was limited due to non-standardized, non-machine-readable data formats.
  • The framework demonstrated clear data governance and operational scalability.
  • Anonymized IDs and hash-based indices facilitated temporal reconstruction while preserving privacy.

Conclusions:

  • The developed framework offers a practical and scalable solution for FAIR-oriented secondary use of clinical data.
  • It supports secure and efficient data sharing in medical institutions, balancing data utility and patient privacy.
  • Addressing data standardization is crucial for improving interoperability in future iterations.