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Related Concept Videos

Quality Assurance01:19

Quality Assurance

174
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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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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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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Clinical Trials: Overview01:11

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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...
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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.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Health Information Technology and Healthcare Information System01:30

Health Information Technology and Healthcare Information System

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Health Information Technology (HIT)
Health Information Technology, commonly called HIT, integrates advanced information systems and technology in healthcare settings. Its primary functions include:
891

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Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care
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Building and implementing a quality assurance/quality improvement program for clinical research.

Reva Bruns1, Marietta Barton-Baxter1, Roxane Poskin1

  • 1Center for Clinical and Translational Science, University of Kentucky, Lexington KY USA.

Applied Drug Research, Clinical Trials and Regulatory Affairs
|January 9, 2023
PubMed
Summary

A Quality Assurance/Quality Improvement program enhances clinical research by improving study design and PI education. This initiative proved effective, educational, and well-accepted by stakeholders, fostering rigorous, ethical, and safe research practices.

Keywords:
Quality assuranceclinical researchgood clinical practiceprogram developmentquality improvementreview

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Area of Science:

  • Clinical and Translational Science
  • Research Quality Improvement

Background:

  • Clinical and Translational Science Award programs aim to advance research.
  • Ensuring study teams adhere to best clinical research practices is crucial.

Purpose of the Study:

  • To establish a Quality Assurance/Quality Improvement (QA/QI) program for Principal Investigator (PI)-initiated studies.
  • To enhance research design quality and PI education proactively.
  • To ensure clinical research is rigorous, ethical, and safe.

Main Methods:

  • The University of Kentucky Center for Clinical and Translational Science developed a QA/QI program in 2011.
  • The program focused on a "find it, fix it" approach to improve research quality from inception.
  • The program aimed to be educational rather than punitive.

Main Results:

  • The QA/QI program has achieved good acceptance among PIs.
  • The program's scope has expanded since its initiation.
  • Review processes have been adapted to meet PI needs.

Conclusions:

  • A well-developed QA/QI program can be efficient, effective, and educational.
  • Such programs are well-accepted by clinical research stakeholders.
  • Implementing QA/QI programs supports the growth of clinical and translational research.