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Related Concept Videos

Quality Assurance01:19

Quality Assurance

Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
Quality Control01:05

Quality Control

Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
Ethical Standards II01:23

Ethical Standards II

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 and...
Confirmation Biases01:31

Confirmation Biases

The confirmation bias is the tendency to focus on information that confirms our existing beliefs and ignore information that is inconsistent with our expectations. For example, if you think that your professor is not very nice, you notice all of the instances of rude behavior exhibited by the professor while ignoring the countless pleasant interactions he is involved in on a daily basis. Have you ever fallen prey to the confirmation bias, either as the source or target of such bias?
Independent and Dependent Sources01:18

Independent and Dependent Sources

In electrical circuits, sources play a crucial role in providing power for the operation of the circuit. These sources can be broadly categorized into two types: independent and dependent.
Independent voltage or current sources supply a fixed amount of voltage or current, respectively, which is unaffected by other elements within the circuit. These are represented using specific symbols. Independent voltage sources are symbolized with polarities (+ and -), indicating the direction of the...

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Related Experiment Video

Updated: Jun 26, 2026

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

Lessons learned from independent central review.

R Ford1, L Schwartz, J Dancey

  • 1RadPharm, 100 Overlook Center, Princeton, NJ 08540, USA. ford@radpharm.com

European Journal of Cancer (Oxford, England : 1990)
|December 23, 2008
PubMed
Summary
This summary is machine-generated.

Independent central review (ICR) verifies clinical trial endpoints using medical imaging for regulatory submissions. This article discusses ICR

Related Experiment Videos

Last Updated: Jun 26, 2026

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:

  • Oncology
  • Clinical Trials
  • Medical Imaging

Background:

  • Independent central review (ICR) is mandated by regulatory bodies for verifying imaging-dependent clinical trial endpoints in drug licensing.
  • ICR is also utilized by trial sponsors in early-phase studies for critical decisions, including compound in-licensing.

Purpose of the Study:

  • To define and explain the purpose of independent central review (ICR).
  • To discuss the challenges and lessons learned from implementing ICR in Phase II and III oncology trials.

Main Methods:

  • Focus on the definition and purpose of ICR.
  • Discussion of issues encountered in the ICR setting, including interpretation discordance and operational challenges.

Main Results:

  • Exploration of discordance between local and central imaging interpretations.
  • Analysis of consequences arising from ICR, including reader variability.
  • Identification of operational considerations and the necessity for precise imaging requirements in study protocols.

Conclusions:

  • ICR is a critical component for ensuring the reliability of imaging endpoints in oncology drug development.
  • Addressing discordance and optimizing operational aspects are key to successful ICR implementation.