ICH-Good Clinical Practice E6 R2 (GCP) is the international ethical and quality standard describing the responsibilities and expectations for the conduct of research involving human participants, including the design, execution, recording and reporting of clinical trials. Compliance provides assurance of the protection of the rights of research participants, the integrity of study data and the conclusiveness of study results. Link to the standard is below;
Whilst there are plenty of GCP training courses offered by different organisations, there is no actual GCP ‘qualification’. It is being aware of your responsibilities, whether as an investigator, study coordinator, monitor or any other role in a study, that typically defines someone as being ‘trained’ in GCP.
GCP is not a legal requirement in New Zealand as it is in Europe and the USA for specific types of studies; however the principles should be adopted by all types of clinical studies to ensure that all research is conducted to a similar standard.
GCP should be applied in a pragmatic manner, taking into account the needs and requirements of the community within which the research is being carried out.
Auckland DHB is committed to clinical research excellence and growing capability in the research workforce. GCP training is mandatory for all named investigators on new applications for research approval of interventional studies.
The Global Health Training Centre offers a free GCP training resource on their website. Investigators and research staff can take this training online.
The aim of the tool is to provide a resource that:
Provides all parties in the clinical trials industry with a clear and consistent understanding of what the various components and terms involved in costing for clinical trials mean.
Gives research teams and their organisations a clear and accurate picture of the financial implications of conducting a trial so that decisions can be made based on sound information.
Is sufficiently uncomplicated (despite the complexity of clinical trial costing) that it can be used by busy research teams whether or not there is dedicated assistance and support within the organisation.