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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...
Nursing Clinical Information System01:27

Nursing Clinical Information System

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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Related Experiment Video

Updated: Jul 16, 2026

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)
04:11

A Video Protocol of a Randomized Controlled Clinical Trial - Electrochemotherapy of Cutaneous Metastases with Reduced Dose Bleomycin (BLESS Trial)

Published on: June 9, 2026

Web-based electronic data collection system to support electrochemotherapy clinical trial.

Ivan Pavlović1, Damijan Miklavcic

  • 1Faculty of Electrical Engineering, University of Ljubljana, SI-1000 Ljubljana, Slovenia. ivan@lbk.fe.uni-lj.si

IEEE Transactions on Information Technology in Biomedicine : a Publication of the IEEE Engineering in Medicine and Biology Society
|March 30, 2007
PubMed
Summary

This study introduces a Web-based electronic data collection (EDC) system to improve clinical trial data management. The system enhances data quality and analysis for electrochemotherapy trials, moving beyond traditional paper records.

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Area of Science:

  • Medical Informatics
  • Clinical Research Technology
  • Digital Health

Background:

  • Information and communication technology (ICT) is transforming healthcare, yet clinical trials largely rely on paper records.
  • Electronic data collection (EDC) tools are advancing, offering potential to reduce paper-based processes.
  • Establishing Standard Operating Procedures (SOPs) for novel medical devices requires robust data collection and analysis.

Purpose of the Study:

  • To present a Web-based EDC system for a small-scale clinical trial on electrochemotherapy using the Cliniporator device.
  • To facilitate the collection and analysis of treatment parameters essential for defining SOPs.
  • To encourage the adoption of Internet and Web technologies in clinical trial data management.

Main Methods:

  • Developed a central database and Web application for data submission from multiple European medical centers.
  • Integrated data transmission from local Cliniporator devices, including tumor images and interactive mapping.
  • Implemented data quality assurance mechanisms: automatic validation, digital signatures, and alerting systems.
  • Performed statistical data analysis throughout the data collection period.

Main Results:

  • The system successfully collected and managed data from distant medical centers across Europe.
  • Data quality was enhanced through multiple validation and notification features.
  • Usability evaluation after 13 months provided insights into user experience.

Conclusions:

  • Web-based EDC systems can significantly improve clinical trial data collection, follow-up, and analysis.
  • The developed system supports the establishment of SOPs for new medical devices like the Cliniporator.
  • Adopting Internet and Web technologies is crucial for modernizing clinical trial processes.