Welsh Government

Good Clinical Practice (GCP) refresher

Course Outline:

This half day course fulfils the requirements for a GCP training update and has been developed by the NIHR in collaboration with the MHRA. It is aimed at all research personnel.

This full day course fulfils the requirements for GCP training and has been developed by the NIHR in collaboration with the MHRA. It is aimed at newly appointed research delivery personnel who are involved in research studies.

Both the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) advocate a proportionate approach to the application of GCP and the appropriate training of staff involved in clinical trials and as such, have released a joint HRA/MHRA statement on the Application of Good Clinical Practice Training for Researchers (v1.1 October 2017) to clarify requirements for GCP training. This has been endorsed by all four UK nations.

The joint statement states training forms one component of the systems for ensuring high quality research. Training should be appropriate and proportionate to the study type, relevant to specific research roles and activities undertaken by staff involved in health and social care research and may range from a detailed knowledge of GCP principles and associated UK Regulations to an awareness of particular GCP principles.

The course is designed to update research professionals and staff by exploring the principles and standards of GCP, the EU Directives, UK Regulations and Research Governance Framework requirements covering clinical trials and other research studies conducted in Wales. Course participants will have opportunity for reflection on their own practice within the context of recent developments, utilising real case examples.

Please note the course runs from 9.30 am – 1.00pm and a certificate of attendance will only be issued if delegates complete all elements of the training.

This course is accredited by the CPD Certification Service (3 Hours) and the Royal College of Physicians (3 CPD points)

 


Following the training, participants will be able to: 

  • Identify the laws, frameworks and guidelines which govern the set up and conduct of clinical research
  • Reflect on their own practice in terms of consistency with the GCP principles and standards
  • Identify areas for improvement that reflect common audit and inspection findings
  • Describe recent developments in the regulation of research
  • Aim to transfer GCP knowledge gained from this training into daily practice, to ensure the rights, safety and wellbeing of participants and the quality of the data.

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