Welsh Government

Introduction to Good Clinical Practice (GCP)

Course Outline:

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 meet the needs of people who are recruiting participants and gathering study data in local research sites in order to apply GCP and the EU Directives, UK Regulations and Research Governance Framework into daily practice. This includes clinical trials and other research conducted within health and social care settings in Wales.  The day is built around group activities and work-based scenarios with the aim of preparing participants to improve their implementation of GCP when they return to their workplace.

Please note 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 (6.5 Hours) and the Royal College of Physicians (6 CPD points)

 


Following the training, participants will be able to: 

  • Understand the laws, frameworks and guidelines which govern the set up and conduct of clinical and non-clinical research
  • Understand the roles and responsibilities of individuals and organisations in research
  • Identify essential documents for the conduct of research
  • Understand the process, roles and responsibilities of receiving informed consent
  • Demonstrate accuracy in case report form completion and data query resolution
  • Demonstrate correct safety reporting requirements

Search for this course here: