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Related Concept Videos

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...
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...
Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

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 illness...
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...
Flow Sheet01:17

Flow Sheet

Flowsheets are valuable tools in nursing documentation. They enable healthcare professionals to efficiently record and monitor various patient assessments and measurements in a consolidated format.
Here's a closer look at the examples of flowsheets commonly used by nurses:
Graphic Sheet Documentation:
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...

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Related Experiment Video

Updated: Jun 21, 2026

Radiation Planning Assistant - A Web-based Tool to Support High-quality Radiotherapy in Clinics with Limited Resources
05:18

Radiation Planning Assistant - A Web-based Tool to Support High-quality Radiotherapy in Clinics with Limited Resources

Published on: October 6, 2023

Process maps in clinical trial quality assurance.

Daniel H Rosen1, Sandra Johnson, Poloko Kebaabetswe

  • 1CDC, Global AIDS Program, CDC - GAP, Atlanta, GA, USA. drosen@psi.org

Clinical Trials (London, England)
|July 24, 2009
PubMed
Summary
This summary is machine-generated.

Process maps visualize clinical trial workflows, identifying deviations from standard operating procedures (SOPs). This simple tool helps ensure trials run correctly and efficiently, improving overall quality.

More Related Videos

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care
14:32

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care

Published on: February 16, 2011

Related Experiment Videos

Last Updated: Jun 21, 2026

Radiation Planning Assistant - A Web-based Tool to Support High-quality Radiotherapy in Clinics with Limited Resources
05:18

Radiation Planning Assistant - A Web-based Tool to Support High-quality Radiotherapy in Clinics with Limited Resources

Published on: October 6, 2023

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care
14:32

Using Visual and Narrative Methods to Achieve Fair Process in Clinical Care

Published on: February 16, 2011

Area of Science:

  • Clinical research methodology
  • Process improvement techniques

Background:

  • Process maps are standard tools for continuous improvement, illustrating sequential steps and decisions.
  • While well-suited for displaying trial processes, process maps are not routinely used in clinical trials.

Purpose of the Study:

  • To present process maps as a tool for visualizing and monitoring the correctness of clinical trial workflows.
  • To demonstrate that process maps can ensure trial processes adhere to Standard Operating Procedures (SOPs).

Main Methods:

  • Process maps were created based on SOPs and actual trial procedures.
  • Maps derived from SOPs served as the gold standard for comparison.
  • Differences between SOP-derived maps and implemented procedures were identified.

Main Results:

  • Eight process maps were generated from each source (SOP and implemented procedures).
  • A total of 172 discrepancies were found between the SOP maps and the walkthrough maps.
  • Identified differences included extra steps, incorrect order, step errors, and ambiguities.

Conclusions:

  • Process maps effectively identify and correct divergences in clinical trial processes.
  • Further research should explore using process maps during trial design and quantifying their cost-benefit ratio.