Target Audience: New clinical research staff (Research Nurses/Facilitators/support staff/ Data Managers) who have been working in a research role for less than one year. The course provides a basic overview of research roles and the clinical research process which builds on the theory and practical sessions of ICH Good Clinical Practice training. It is intended for site staff from any clinical speciality who are involved in the conduct of clinical research.
Individuals involved in the design and management of studies should be aware that it will not address their specific needs.
Evidence of GCP training (e.g. one day NIHR Introduction to GCP) will be required prior to enrolment on this course.
Aims & Objectives: At the end of the course participants should have a basic insight and understanding of-
- The context of clinical research in the NHS
- The key roles and responsibilities of members of the Research Team
- The aims and designs of different phases of clinical trials
- Logistics and practicalities in setting up a research study at site
- The relevance of different specimens and diagnostic tests
- Key issues relating to data quality and management
- The role of support services: Pharmacy, Labs & Imaging
- Opportunities for training and development in a clinical research role
Course Summary: The course will include a mixture of short presentations and activities, which will provide an overview rather than an in-depth understanding. Additional reading and resources for each topic will be provided.