Good Clinical Practice Training
Good Clinical Practice (GCP) Training is a key requirement for individuals involved in clinical research, and is designed to ensure that those involved in conducting a trial are qualified by education, training and experience to perform their respective tasks.
The NIAA strongly supports GCP training for all research-active and interested colleagues and endorses the training courses offered by the National Institute for Health Research (NIHR). The NIHR provides both online and face-to-face opportunities through an introductory e-learning module and targeted, full-day workshops.
The courses are aimed at staff involved in studies that have been accepted on to the NIHR's Clinical Research Network (CRN) Portfolio and is suitable for people conducting CTIMP (Clinical Trial of an Investigational Medicine Product) and non-CTIMP courses.
Access
To access this training you will first need to register for the NIHR's Learning Management System using an NHS or university email address. More details about how to register can be found here.
If you have any queries about accessing these modules please contact the NIHR at:
crncc.training@nihr.ac.uk .
Expected learning outcomes
Following the introductory GCP course, participants will have a demonstrable understanding of the background and practical implications of GCP. This understanding is intended to be a foundation for action, bridging the gap between theory and practice in their places of work.
Participants should be able to:
- Demonstrate an understanding of the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
- Demonstrate an understanding of the roles and responsibilities of different individuals and organisations in clinical research
- Understand the regulatory applications required before clinical research can be started in the UK
- Identify a range of essential documents and the purpose of maintaining a trial master file
- Understand the process of receiving informed consent and the roles and responsibilities of those involved in this process
- Demonstrate the ability to correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
- Demonstrate an awareness of the correct safety reporting requirements that ensure patient safety
- Know where to go for further advice and support and how to keep updated.
Further information
Please click here to find out more about the NIHR's GCP training scheme.
