Glossary

All manufacturing activities will need to be conducted in a unit which has an IMP manufacturing authorisation with a named Qualified Person (QP).

This person ensures that an investigation medicinal product (IMP) batch is only released if there is documentation to confirm compliance with Good manufacturing Practice (or equivalent).

All those planned and systematic actions that are established to ensure that the trial is performed and the data is generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.