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Related Concept Videos

Quality Control01:05

Quality Control

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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...
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Errors occurring during blood pressure monitoring01:25

Errors occurring during blood pressure monitoring

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Blood pressure monitoring is a crucial clinical procedure in diagnosing and managing various cardiovascular conditions. Despite its significance, the accuracy of blood pressure measurements can be compromised by multiple factors, potentially leading to either falsely high or low readings. These inaccuracies are critical as they can significantly impact patient care. So, it is vital to understand these challenges deeply and adopt strategic approaches to minimize errors.
Several factors...
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Quality Assurance01:19

Quality Assurance

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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...
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Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

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Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
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Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

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The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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.
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Risk-Based Quality Management: A Case for Centralized Monitoring.

Nicole Stansbury1, Danilo Branco1, Cris McDavid1

  • 1Association of Clinical Research Organizations (ACRO), 601 New Jersey Ave NW #350, Washington DC, 20001, USA.

Therapeutic Innovation & Regulatory Science
|December 11, 2024
PubMed
Summary
This summary is machine-generated.

Risk-based quality management (RBQM) adoption in clinical trials shows strong risk assessment use but lags in other areas. Centralized monitoring is underutilized, missing opportunities for improved patient safety and data quality.

Keywords:
Centralized monitoringClinical trial qualityRBMRBQMRisk-based monitoringRisk-based quality management

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Area of Science:

  • Clinical research
  • Pharmaceutical sciences
  • Regulatory affairs

Background:

  • The Association of Clinical Research Organizations has surveyed Risk-Based Quality Management (RBQM) adoption since 2019.
  • Four years of survey data, including 2022 results from 4958 trials across seven CROs, are presented.
  • The 2022 survey focused on 1004 new clinical trial starts.

Purpose of the Study:

  • To analyze the adoption trends of RBQM elements in clinical trials.
  • To identify gaps in RBQM implementation beyond initial risk assessment.
  • To advocate for increased utilization of centralized monitoring and Quality Tolerance Limits (QTLs).

Main Methods:

  • Analysis of four years of landscape survey data on RBQM adoption.
  • Focus on 2022 survey data from 4958 clinical trials.
  • Development of a case study demonstrating RBQM implementation.

Main Results:

  • Overall risk assessment adoption is strong, but other RBQM components lag.
  • New study starts show nearly 50% adoption for most RBQM elements.
  • Centralized monitoring is underutilized despite its potential benefits.

Conclusions:

  • Companies may not fully benefit from RBQM due to incomplete implementation.
  • Industry views on Quality Tolerance Limits (QTLs) are mixed.
  • Increased adoption of centralized monitoring is crucial for efficient and effective clinical trials.