Basics of Quality Management in CT

1. Why Quality Management?

1.1. What Could Actually Go Wrong When Conducting a Clinical Trial?

  • Wrong medication given to patient.
  • Measurements taken at the wrong time.
  • Participant did not show up for appointment.
  • Participant included in the trial even though they were not eligible.
  • Adverse reaction not reported.
  • No back-up of data entered into the computer.
  • Wrong statistical analysis is being used to calculate the result of the trial.
When thinking about this question one realises that many things could go wrong in the course of a clinical trial. These were some examples, but many more can be found.

It also becomes evident that most of the mistakes that can occur during a clinical trial can be avoided simply by proper planning and regular control of the trial procedures. This is what is understood as ‘quality management’.

Quality management is described in the Guideline for Good Clinical Practice (ICH-GCP guideline). It is the responsibility of the ‘sponsor’ i.e. the person, institution, organisation or company that takes responsibility for initiation, management and/or financing of the clinical trial. If the trial is large, the sponsor may not be able to oversee all activities and might even lack the necessary qualifications for ensuring the proper quality of all steps of the trial. In such circumstances, the sponsor is obliged to hire qualified people to help ensure that the trial is planned, conducted and analysed correctly.

Quality management activities can be divided into two sub-groups – those done before starting the trial (quality assurance or QA) and those done after the trial has been initiated (quality control or QC). Examples of these activities are described below.

Quality assurance (QA) can be described as the activities done in order to avoid any mistakes happening, whereas quality control (QC) might be described as the activities done in order to identify and to correct mistakes that have occurred. Both are regarded as equally important and it should always be carefully considered how to incorporate both QA and QC activities in each individual trial. They are necessary to ensure the validity of the trial.

The following parts of this lesson describe the QA and QC activities as defined in the GCP-guideline.