Autoscribe Informatics

Matrix Gemini Lims at work in Cancer research trials case study


Courtesy of Autoscribe Informatics

Executive Summary
The Roy Castle Lung Cancer Foundation (RCLCF) is a UK wide charity, dedicated to the defeat of lung cancer. It funds basic science research, tobacco control initiatives and work in lung cancer patient information, support and advocacy. RCLCF works towards defeating lung cancer through research, campaigning and education and gives practical and emotional support for patients and all those affected by lung cancer and smoking. It also enables children and young people to make informed decisions about smoking and the tobacco industry.

RCLCF funds a programme of research into the early detection of lung cancer. One of these projects is the Liverpool Lung Project which is a study researching the early diagnosis of lung cancer. The main aim of this research programme is to identify people who are at especially high risk of developing lung cancer by using molecular genetics technologies and epidemiology. The research team is led by Professor John Field.

Clinical trial research facilities like RCLCF and computer systems that involve the storage of Human Tissue Samples need to be compliant with the Human Tissue Act (2006). The competent auditing authority is the MHRA and the relevant statutes are the EU Clinical Trials Directive (20001/20/EC and 2005/28/EC) and subsequent UK laws (statutory Instrument 1031, 1928, 2984 and 2031) covering the conduct of clinical trials in accordance with Good Clinical Laboratory Practice (GCLP). Compliance with GCLP guidelines allows clinical laboratories to ensure the safety and efficacy of data and that it is repeatable, reliable, auditable and can be easily reconstructed and audited in a research setting.

Key Objectives for implementing a LIMS at RCLCF

  • Comply with current and future regulatory requirements and associated audits
  • Improve the method for booking in samples
  • Logging of booked out samples and their usage
  • User friendly system that makes sample editing and auditing easy to use
  • Integration with IBM System Builder Database
  • Select a system that can easily be configured to meet current and future needs
  • Select a system with a track record of backward compatibility and ease of upgrade
  • Purchase a compliant system that RCLCF staff could configure themselves from a reputable supplier

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