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Related Concept Videos

Clinical Trials01:16

Clinical Trials

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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...
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Guidelines and Strategies for Safe Computer Charting01:18

Guidelines and Strategies for Safe Computer Charting

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The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
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Ethical Standards I01:25

Ethical Standards I

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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,...
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Ethical Standards II01:23

Ethical Standards II

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Ethical standards are the backbone of nursing practice, guiding nurses as they interact with patients, families, and colleagues. These standards are crucial for providing safe, empathetic care centered on the patient's needs.
Nurses are entrusted with upholding various ethical principles and standards. Nurses forge solid therapeutic relationships using trust, empathy, autonomy, confidentiality, and professional competence.
Confidentiality is crucial, embodying respect for individual privacy...
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Purpose of Health Records II01:19

Purpose of Health Records II

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Health records serve various essential purposes in the healthcare system. Here are some key purposes:
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Nursing Clinical Information System01:27

Nursing Clinical Information System

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Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
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Updated: Jul 11, 2025

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Scrybe: A Secure Audit Trail for Clinical Trial Data Fusion.

Jonathan Oakley1, Carl Worley1, L U Yu1

  • 1Clemson University, USA.

Digital Threats : Research and Practice
|November 8, 2023
PubMed
Summary

Scrybe, a novel permissioned blockchain, enhances clinical trial data integrity by addressing regulatory compliance challenges posed by modern smart devices. This solution ensures reliable electronic records and tamper resistance in clinical research.

Keywords:
BlockchainClinical TrialsISO 27789REDCapSecure AuditTitle 21 CFR Part 11

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Area of Science:

  • Computer Science
  • Biomedical Informatics
  • Cybersecurity

Background:

  • Clinical trials face significant challenges meeting regulatory requirements like 21 CFR Part 11 and ISO 27789.
  • The increasing use of smart and wearable IoT devices in trials expands the attack surface and complicates data management.
  • Existing Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) are not equipped to handle these new data sources.

Purpose of the Study:

  • To propose Scrybe, a permissioned blockchain solution for storing proof of clinical trial data provenance.
  • To demonstrate how Scrybe addresses regulatory controls for electronic records.
  • To evaluate the limitations of Ethereum-based blockchains for this application.

Main Methods:

  • Development of Scrybe, a permissioned blockchain architecture.
  • Analysis of Scrybe's alignment with 21 CFR Part 11 and ISO 27789 controls.
  • Proof-of-concept integration of Scrybe with REDCap (Research Electronic Data Capture).

Main Results:

  • Scrybe provides a robust mechanism for ensuring the provenance and tamper resistance of clinical trial data.
  • The proposed blockchain addresses key audit requirements for electronic records, particularly with novel data sources.
  • A proof-of-concept demonstrated successful integration and tamper-evident data storage with REDCap.

Conclusions:

  • Scrybe offers a viable solution to enhance data integrity and regulatory compliance in clinical trials utilizing modern devices.
  • Blockchain technology can effectively secure and validate electronic health records in research settings.
  • Further research into blockchain applications for clinical trial data management is warranted.