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phuse_rbm_qtl

Data and code for Phuse RBM QTL survey data analysis white paper.

https://github.com/poncest/phuse_rbm_qtl

Science Score: 31.0%

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Keywords

datavisualization research-paper rprogramming survey-analysis survey-data tidyverse
Last synced: 6 months ago · JSON representation ·

Repository

Data and code for Phuse RBM QTL survey data analysis white paper.

Basic Info
  • Host: GitHub
  • Owner: poncest
  • License: mit
  • Language: R
  • Default Branch: main
  • Homepage:
  • Size: 38.6 MB
Statistics
  • Stars: 1
  • Watchers: 1
  • Forks: 0
  • Open Issues: 1
  • Releases: 0
Topics
datavisualization research-paper rprogramming survey-analysis survey-data tidyverse
Created over 2 years ago · Last pushed almost 2 years ago
Metadata Files
Readme License Citation Authors

README.md

Phuse Risk Base Monitoring - Quality Tolerance Limits (RBM-QTL)

Introduction

This project supports the publication of the RBM-QTL white paper by generating necessary figures. Quality Tolerance Limits (QTL) are statistical tools used in pharmaceutical industries to ensure quality in clinical trials.

Project Goal

  • Generate figures supporting the publication of the RBM-QTL white paper.

Generating Figures

  • Initial Work:

    • Early exploratory analysis.
    • Run the following command in R: source("01_scripts/01_initial_work/04_runfile.R")

  • Selected Figures:

    • Figures selected based on author feedback.
    • Run the following command in R: source("01_scripts/02_selected_figures/04b_selected_runfile.R")

  • Updated Figures:

    • Figures updated based on reviewer feedback.
    • Run the following command in R: source("01_scripts/03_updated_figures/04c_updated_runfile.R")

Additional Information

Folder Structure

Access the White Paper

  • Online version available HERE.
  • PDF copy available in this repository HERE.

Abstract

Risk-based quality management (RBQM) has been encouraged since 2013, when the EMA published a reflection paper on RBQM to support effective monitoring and quality of clinical trials RBQM applies the quality by design (QbD) principles, and, over the past several years, the industry’s understanding of a QbD approach to clinical trials has improved Using QbD encourages designing quality into a trial during the planning phase. The identification of critical to quality factors (CtQs) as part of QbD is key to implementing RBQM.

One method of monitoring risk associated with CtQs is to use quality tolerance limit (QTL) parameters which are linked to the key scientific question(s) of a trial and identify systemic issues that can jeopardize the integrity of trial endpoints.

This white paper aims to provide the reader with valuable insights into the depth and breadth of QTL use by surveying the industry. It will also address how QTLs are used in the wider scope of implementing RBQM and the direction of stakeholders, given that the regulations regarding the conduct of clinical trials continue to evolve.

Contact Information

For questions or support, please contact workinggroups@phuse.global.

Owner

  • Name: Steven Ponce
  • Login: poncest
  • Kind: user

Citation (CITATION.md) 

# Citation

Please cite this work in your publications if it contributes to your research. The citation format provided below follows a commonly accepted academic standard.

## Recommended Citation

Wells, C., Lovejoy, M., Walega, M., Borrendam, N., Krohn, J., Proeve, J., Spiridon, M.-D., Stullcap, K., & Seider, B. (2024). Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry. PHUSE - Risk Based Quality Management Working Group. Available at [PHUSE](https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Risk+Based+Monitoring/WP-084.pdf)

## BibTeX

```bibtex
@misc{phuse2024qtl,
  author = {Wells, Chris and Lovejoy, Mireille and Walega, Michael and Borrendam, Nathalie and Krohn, Jennifer and Proeve, Johann and Spiridon, Madalina-Daniela and Stullcap, Kristin and Seider, Barbara},
  title = {Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry},
  year = {2024},
  publisher = {PHUSE - Risk Based Quality Management Working Group},
  howpublished = {\url{https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Risk+Based+Monitoring/WP-084.pdf}}
}

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