Basics of Quality Management in CT


1. Why Quality Management?

You have already learned enough about clinical trials to know that it generally takes a lot of resources to set one up. No matter whether it is a large international trial conducted at several centres, or just a small trial with few patients at a single centre, clinical trials are always expensive. They cost a lot of money, e.g. for medicine, laboratory tests, databases, extra personnel, etc. But they are also expensive in terms of the time that they take:

  • The researchers involved often need to spend a lot of time on both scientific and administrative tasks.
  • The sponsor spends time monitoring the trial.
Another important point is that a clinical trial uses the time and energy of the patients who are willing to participate without even knowing if the experiment will lead to a useful treatment.

It is easy to understand how important it is to prevent anything unforeseen happening that would put the safety participants and the result of the trial at risk.

What could actually go wrong when conducting a clinical trial?